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Archive for February, 2017

  • Accelerate Diagnostics Receives FDA Marketing Authorization for the Accelerate Pheno™ System and Accelerate PhenoTest™ BC Kit

    by on February 24th, 2017

    TUCSON, Ariz., Feb. 23, 2017 (GLOBE NEWSWIRE) — Accelerate Diagnostics, Inc. (Accelerate) today announced that the U.S. Food and Drug Administration has granted the de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis.

    The Centers for Disease Control and Prevention estimate at least 2 million people each year are infected with antibiotic resistant bacteria across the U.S. In addition, antibiotic resistance contributes to the morbidity and mortality of healthcare-associated infections (HAI) that kill an estimated 75,000 people annually.1

    “The ability to provide not only rapid identification but also rapid phenotypic susceptibility ensures patients receive the most effective and appropriate therapy in a timely manner,” said James Lewis, PharmD, Infectious Diseases Clinical Pharmacy Coordinator and Adjunct Associate Professor at Oregon Health and Science University and member of the CLSI Subcommittee on Antimicrobial Susceptibility Testing. “We know each hour of inadequate antibiotic therapy increases mortality and that excessive use of broad spectrum agents drives resistance. The faster we can tailor therapy, the better things are for the patient and the potential prevention of antibiotic resistance.”

    Culture based identification and susceptibility systems require time consuming manual procedures, resulting in laboratory processing time that often exceeds 48 hours. With the Accelerate PhenoTest™ BC kit, labs can reduce the turnaround time by testing directly from positive blood culture samples, producing results up to 40 hours faster than conventional methods.

    The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility testing methods intended for use with the Accelerate Pheno™ system. The blood culture kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms using morphokinetic cellular analysis (MCA) of individual microbial cells and colonies under the challenge of antibiotics.

    The Accelerate clinical study included more than 39,000 tests conducted on 1,850 samples across 13 trial sites and exceeded the requirements of the FDA for identification and antimicrobial susceptibility testing. The study showed overall sensitivity of 97.4% and specificity of 99.3% for identification. For susceptibility, overall essential and categorical agreement versus standard broth microdilution was 96.3% and 96.4% respectively.2

    The Accelerate PhenoTest™ BC kit includes 140 assays for both identification and susceptibility testing, of which 116 were submitted to the FDA. The kit also includes what Accelerate refers to as a “definitive” monomicrobial test indicating when a patient’s positive blood culture sample has only one targeted pathogen. In the Accelerate clinical trial the monomicrobial result had a 99.6% positive predictive value (PPV) when evaluated in combination with the Gram stain.  The monomicrobial result, matched with a Gram stain, allows microbiologists to report results without additional laboratory workup.

    “We are excited to offer microbiologists and treating physicians earlier intelligence about the infections they fight on a daily basis,” said Lawrence Mehren, President and CEO of Accelerate Diagnostics, Inc. “Bringing this solution to market has been a culmination of years of effort. I could not be more proud of the Accelerate team, more grateful to our clinical trial partners, or appreciative of the FDA’s guidance throughout this endeavor.”

    The FDA granted the de novo request from Accelerate to legally market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for in vitro diagnostic use. The de novo classification process provides a regulatory pathway intended to expedite FDA review of novel low-to-moderate risk devices for which no predicate device exists when special and general controls demonstrate reasonable assurance of safety and effectiveness.

    Accelerate will discuss the de novo request granted by the FDA with investors and analysts on its preliminary earnings conference call scheduled for, Monday, February 27, 2017 at 4:15pm ET. A live audio webcast of the call will be accessible from the investor portal of the company’s website at axdx.com/investors.

    Visit axdx.com to get more information about the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit.

    References:

    1. Reports from the Centers for Disease Control and Prevention can be found at cdc.gov/hai/surveillance/ and cdc.gov/drugresistance/
    2. Overall results are based on FDA/CLSI 2016 breakpoints – see product labeling for additional detail

    About Accelerate Diagnostics, Inc.

    Accelerate Diagnostics, Inc. (“Accelerate Diagnostics,”) (Nasdaq:AXDX), is an in vitro diagnostics company dedicated to providing solutions for the global challenge of antibiotic resistance and healthcare-associated infections. The company’s fully automated Accelerate Pheno™ system, and direct from positive blood culture Accelerate PhenoTest™ BC kit, leverage a suite of technologies to eliminate the lengthy culture and sample preparation steps required prior to testing. Using proprietary molecular identification methods and morphokinetic cellular analysis (MCA), the solution aims to reduce the time that clinicians must wait for quantitative antimicrobial susceptibility results necessary for optimal antibiotic selection, dosing, and infusion strategy, called minimum inhibitory concentrations, or MICs.

    The “ACCELERATE DIAGNOSTICS”, “ACCELERATE PHENO” and “ACCELERATE PHENOTEST” logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.

    Forward-Looking Statements

    Certain of the statements made in this press release are forward looking, such as those, among others, about our projections as to when certain key business milestones may be achieved, the potential of our products or technology, the growth of the market, our estimates as to the size of our market opportunity and potential pricing, our competitive position and estimates of time reduction to results, and our future development plans and growth strategy. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Information about the risks and uncertainties faced by Accelerate Diagnostics is contained in the section captioned “Risk Factors” in the company’s most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 9, 2016, and in any other reports that we file with the Securities and Exchange Commission from time to time. The company’s forward-looking statements could be affected by general industry and market conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.

    CONTACT: Investors May Contact:
    Laura Pierson, Accelerate Diagnostics, +1 520 365-3100
    investors@axdx.com
    
    Reporters May Contact:
    Andrew Chasteen, Accelerate Diagnostics, +1 520 365-3100
    achasteen@axdx.com
  • EyeGate Pharmaceuticals Reports Full-year 2016 Financial Results and Provides Business Update

    by on February 23rd, 2017

    WALTHAM, Mass., Feb. 23, 2017 (GLOBE NEWSWIRE) — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced financial results for the twelve-month period ended December 31, 2016, and provided an update on recent corporate and operational achievements.

    2016 and Recent Business Highlights:

    • Entered into exclusive, worldwide licensing agreement with Valeant Pharmaceuticals International, Inc. (“Valeant”) for EGP-437 combination product to treat post-operative pain and inflammation in ocular surgery patients. Under the agreement, the Company received an upfront cash payment and is eligible to receive development and commercial milestone payments as well as royalties on the sale of the product;
    • Reported positive top-line data from Phase 1b/2a clinical trial of the EGP-437 combination product for treatment of post-operative inflammation and pain in cataract surgery patients;
    • Received additional milestone payments from Valeant under licensing agreement for EGP-437 combination product in uveitis;
    • Continued enrolling patients in confirmatory Phase 3 clinical trial of the EGP-437 combination product targeting non-infectious anterior uveitis; 
    • Reported positive top-line data from first-in-human pilot study of EyeGate Ocular Bandage Gel (“EyeGate OBG”) in the treatment of corneal epithelial defects;
    • FDA Pre-Submission meeting confirmed 510(k) De Novo regulatory path for EyeGate OBG

    “We made remarkable progress throughout 2016, setting the stage for 2017 to be a potentially transformational year for EyeGate. Following the positive top-line data from our cataract surgery trial reported in the fourth quarter, we recently signed our second licensing agreement with Valeant through which they will commercialize our EGP-437 combination product in this highly prevalent indication. We remain on-track to initiate a placebo-controlled Phase 2b study in cataract surgery patients in the first half of 2017 and continue to target the filing of a supplemental NDA in the second half of 2018,” said Stephen From, Chief Executive Officer of EyeGate. “Our pivotal study of EGP-437 in anterior uveitis, the first indication licensed to Valeant, continues to progress as well. We expect to complete enrollment in Q3 2017 and to report top-line data in Q4 2017, leading to an NDA submission by the end of the year.

    “In addition to the success of the EGP-437 program, 2016 was notable for the expansion of our clinical portfolio through the acquisition of Jade Therapeutics and its novel Cross-linked, Thiolated Carboxymethyl Hyaluronic Acid (CMHA-S) platform. Since completing the acquisition nearly a year ago, we generated positive data from a first-in-human pilot study of our lead CMHA-S product, EyeGate OBG, for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (“PRK”) and are currently planning to initiate a double-masked, controlled trial evaluating EyeGate OBG monotherapy against the current standard of care, bandage contact lens, in Q2 2017. Importantly, our fourth quarter pre-submission meeting with the FDA confirmed that EyeGate OBG will pursue regulatory clearance in the U.S. via the 510(k) De Novo path. Based on the encouraging data from the pilot study as well as continued discussions with the FDA, we are targeting submission of the 510(k) De Novo application by the end of this year. This is truly an exciting time for EyeGate and we believe our outlook has never been more positive. We are grateful to our shareholders for their ongoing support and look forward to sharing details of our future success.”

    Full-year 2016 Financial Review

    Net loss for 2016 was $13.3 million, compared with $8.4 million in 2015.

    Research and development expenses for the year totaled $8.4 million compared with $2.7 million in 2015. The increase of $5.7 million in costs was primarily due to an increase in clinical and other activity, which we were able to undertake after our August 2015 follow-on offering and is also related to the initiation of our Phase 3 clinical trial for the treatment of anterior uveitis, the Phase 1b/2a trial for post-cataract surgery inflammation and pain, the development of and clinical trial for the EyeGate OBG, as well as research expenses attributable to the Company’s EGP-437-based and CMHA-S-based product pipelines.

    General and administrative expenses were $5.6 million, compared with $4.0 million in 2015. The increase of $1.6 million was primarily due to increases in payroll, office and other expenses as company operations have expanded with the increase in clinical activity related to the EGP-437 Phase 3 trials for the treatment of anterior uveitis, the Phase 1b/2a trial for post-cataract surgery inflammation and pain, and the clinical trial for the EyeGate OBG, as well as the expansion of operations following the Jade Acquisition.

    Cash and cash equivalents as of December 31, 2016 totaled $3.6 million, compared with $8.4 million as of December 31, 2015. Cash and cash equivalents as of December 31, 2016 does not include the upfront payment received in conjunction with the recently announced Valeant licensing agreement.

    About EyeGate:

    EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EGP-437, EyeGate’s first product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. In addition, EyeGate is developing, through its wholly-owned Jade subsidiary, products using cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. For more information, please visit www.EyeGatePharma.com.

    Forward-looking Statements

    Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade, a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

    CONTACT: Lee Roth / Janhavi Mohite
    The Ruth Group for EyeGate Pharmaceuticals
    646-536-7012 / 7026
    lroth@theruthgroup.com / jmohite@theruthgroup.com
  • Five Prime Announces Fourth Quarter and Full Year 2016 Financial Results

    by on February 23rd, 2017

    SOUTH SAN FRANCISCO, Calif., Feb. 23, 2017 (GLOBE NEWSWIRE) — Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, today provided a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2016.

    “2016 was a year of tremendous progress in Five Prime’s clinical and preclinical pipeline,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime. “We advanced our three clinical-stage programs and look forward to announcing data from each of these programs this year. With a concerted focus on building out our pipeline, we also unveiled three preclinical programs that we advanced into IND-enabling activities. We are on track to meet our goal of filing at least one IND application for a new molecule each year for the foreseeable future, beginning this year.”

    2016 Business Highlights and Recent Developments

    Clinical Pipeline:

    • Cabiralizumab (FPA008): an investigational antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages. In the setting of advanced cancer, tumor-associated macrophages can inhibit the immune system’s ability to eradicate the disease. In pigmented villonodular synovitis (PVNS), a CSF-1-driven tumor, the bulk of the tumor mass in joints is formed by the macrophages themselves. Five Prime and Bristol-Myers Squibb (BMS) have an exclusive worldwide collaboration agreement for the development and commercialization of cabiralizumab for these and potentially additional indications.

      – Initiated Phase 1b portion of cabiralizumab/OPDIVO trial. 
    In October 2016, Five Prime initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab with the PD- 1 immune checkpoint inhibitor OPDIVO® (nivolumab) in multiple tumor types. Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the combination in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer. Five Prime expects to complete enrollment in the current Phase 1b trial cohorts in the second half of 2017. 

        – Advanced the Phase 2 trial of cabiralizumab in patients with tenosynovial giant cell tumor (TGCT), also known as pigmented villonodular synovitis (PVNS).
    Five Prime expects to complete enrollment of the Phase 2 trial of cabiralizumab in PVNS in the first half of 2017. Five Prime is evaluating clinical measures, including response rate, pain and range of motion in approximately 30 PVNS patients. 

        – Five Prime plans to seek regulatory guidance on a pivotal trial in diffuse PVNS.

        – Five Prime plans to disclose clinical data from the cabiralizumab PVNS trial at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting and from the cabiralizumab immuno-oncology trial in the second half of 2017. 

    • FPA144: an isoform-selective antibody in development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. FPA144 has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Five Prime retains global development and commercialization rights to FPA144.

        – Opened new gastric cancer cohorts and added a bladder cancer cohort in Phase 1 monotherapy trial of FPA144. Enrollment continues in the expansion portion of the trial, evaluating the safety, PK and efficacy of biweekly 15 mg/kg infusions of FPA144 in patients with gastric cancer whose tumors highly overexpress FGFR2b. During the third quarter of 2016, Five Prime added cohorts to evaluate FPA144 in patients with bladder cancer whose tumors overexpress FGFR2b and in patients with gastric cancer whose tumors express moderate or low levels of FGFR2b. Five Prime reported initial single-agent efficacy and safety data at the ASCO 2016 Annual Meeting and at the ASCO 2016 Gastrointestinal Cancers Symposium.

        – Five Prime plans to seek regulatory guidance on a registrational path for FPA144 in combination with chemotherapy as an early-line gastric cancer therapy.

        – Five Prime plans to disclose updated clinical data from the FPA144 program at the ASCO 2017 Annual Meeting.

    • FP-1039: a protein drug designed to block FGF signaling. As a ligand trap, FP-1039 binds to and neutralizes a subset of FGF ligands (such as FGF2), preventing these growth-promoting and angiogenic proteins from reaching FGFR1 on the surface of tumor cells. 

      – Five Prime plans to make decisions on potential future development of FP-1039 in mesothelioma after data on objective response rate, disease control rate and progression-free survival are mature. Five Prime regained full rights to FP-1039 from GlaxoSmithKline (GSK) in September 2016. GSK is completing the ongoing Phase 1b trial combining FP-1039 with 1st-line pemetrexed and cisplatin in untreated, unresectable mesothelioma. GSK concluded trial recruitment with 25 patients enrolled at the 15 mg/kg dose in June 2016, and continues to dose and follow patients. 

      – Five Prime plans to disclose clinical data from this program at the European Society for Medical Oncology (ESMO) 2017 Congress.  

    Preclinical Research and Development:

    • Five Prime unveiled three preclinical development candidates in IND-enabling studies at its R&D Day in New York City in December 2016.

      – FPA150 (anti-B7-H4) 

            — An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC.
            — Investigational New Drug (IND) application planned for the fourth quarter of 2017.

      – FPA154 (GITR agonist antibody)

            — A tetravalent agonist antibody designed for greater GITR activation versus conventional antibodies. Conventional GITR agonist antibodies have two GITR binding sites while FPA154 has four.
            — IND application planned for the fourth quarter of 2017.

      – FPT155 (CD80)

            — A natural, multi-targeting immune modulator that stimulates T cell responses through three critical pathways: CTLA4 blockade, CD28 agonism (without superagonism) and PD-L1 blockade that removes a potent inhibitory checkpoint.
            — IND planned in 2018.

    • Progress in pre-clinical and research programs is on track for the company to achieve the goal of filing at least one IND application for a new molecule each year for the foreseeable future, beginning this year.
       
    • Completed multiple immuno-oncology research screens to identify new targets and drug candidates. Five Prime’s research team completed functional screens on CD8 T cells and regulatory T cells, as well as a comprehensive screen of all extracellular binding interactions in the “immunome,” a defined subset of 700 extracellular proteins enriched for potential immune cell modulators. Five Prime conducted the screens to identify new immuno-oncology targets, which the company is prioritizing for further development as targets for new drug candidates or drug candidates themselves, either as monotherapies or as part of rational combination regimens.
       
    • Five Prime will feature three preclinical research poster presentations during the 2017 American Association for Cancer Research (AACR) Annual Meeting, April 1 – 5, 2017, in Washington, D.C.

    Summary of Financial Results and Guidance:

    • Cash Position. Cash, cash equivalents and marketable securities totaled $421.7 million on December 31, 2016 compared to $517.5 million on December 31, 2015. The decrease in year-end cash in 2016 was primarily attributable to net cash used in operations to advance the company’s clinical and preclinical pipeline.
    • Revenue. Collaboration and license revenue for the fourth quarter of 2016 was $8.3 million compared to $363.3 million for the fourth quarter of 2015. During the fourth quarter of 2015, the company recognized the entire upfront payment of $350 million as revenue under the cabiralizumab license and collaboration agreement with BMS.  Collaboration and license revenue for the full year 2016 was $30.7 million compared to $379.8 million for the full year 2015.
    • R&D Expenses. Research and development expenses for the fourth quarter of 2016 increased by $8.2 million, or 39%, to $29.1 million from $21.0 million in the fourth quarter of 2015. Full year 2016 research and development expenses increased by $23.9 million, or 34%, to $94.1 million in 2016 from $70.2 million in 2015. These increases were primarily related to advancing the FPA144 program in a phase 1 clinical trial, advancing the cabiralizumab program in immuno-oncology and PVNS, and advancing our internal immuno-oncology preclinical and research activities.
    • G&A Expenses. General and administrative expenses for the fourth quarter of 2016 increased by $1.9 million, or 22%, to $10.5 million from $8.6 million in the fourth quarter of 2015. Full year 2016 general and administrative expenses were $35.8 million, an increase of $13.2 million, or 58%, from $22.6 million in 2015. This increase was primarily due to increases in personnel related expenses, including stock-based compensation.
    • Net Income (Loss). Net loss for the fourth quarter of 2016 was $20.1 million, or $0.73 per basic share and diluted share, compared to net income of $296.1 million, or $11.37 per basic share and $10.63 per diluted share, for the fourth quarter of 2015. Full year 2016 net loss was $65.7 million, or $2.44 per basic share and diluted share, compared to net income of $249.6 million, or $9.73 per basic share and $9.23 per diluted share. These decreases in net income were primarily related to recognizing the 2015 upfront payment of $350 million as revenue under the cabiralizumab license and collaboration agreement with BMS. 

    Cash Guidance. Five Prime expects full-year 2017 net cash used in operating activities to be less than $120 million. The company estimates ending 2017 with approximately $300 million in cash, cash equivalents and marketable securities.

    Conference Call Information

    Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 60580589. To access the live webcast please visit the “Events & Presentations” page under the “Investors” tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

    About Five Prime
    Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.

    Cautionary Note on Forward-looking Statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements about (i) the timing of IND filings; (ii) the timing of initiation, progress and scope of clinical trials for Five Prime’s product candidates, including regarding the completion of enrollment in such trials; (iii) Five Prime’s full-year 2017 net cash used in operating activities; and (iv) the estimated amount of Five Prime’s cash, cash equivalents and marketable securities at the end of 2017. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Five Prime’s collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. Other factors that may cause Five Prime’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

      
    Five Prime Therapeutics, Inc. 
    Selected Balance Sheets Data 
    (in thousands) 
          
      December 31, December 31, 
       2016  2015 
    Balance Sheet Data:     
    Cash, cash equivalents and marketable securities $  421,748 $  517,466 
    Total assets    448,281    548,285 
    Total current liabilities (excluding deferred revenue)    24,591    61,859 
    Deferred revenue (in total, including short term portion)   32,006    48,777 
    Total stockholders’ equity     391,575    433,206 
          

     

    Five Prime Therapeutics, Inc.  
    Condensed Statements of Operations  
    (in thousands, except per share amounts)  
              
              
     For The Three Months
    Ended

    December 31,
      For The Year Ended
    December 31,
      
      2016   2015   2016   2015   
    Collaboration and license revenue$  8,262  $  363,341  $  30,691  $  379,801   
    Operating expenses:         
    Research and development   29,149     20,956     94,072     70,197   
    General and administrative   10,522     8,602     35,831     22,631   
    Total operating expenses   39,671     29,558     129,903     92,828   
    Operating income (loss)   (31,409)    333,783     (99,212)    286,973   
    Interest income   646     155     2,467     484   
    Income (loss) before income tax   (30,763)    333,938     (96,745)    287,457   
    Income tax benefit (provision)   10,657     (37,810)    31,048     (37,810)  
    Net income (loss)$  (20,106) $  296,128  $  (65,697) $  249,647   
    Basic net income (loss) per common share$  (0.73) $  11.37  $  (2.44) $  9.73   
    Diluted net income (loss) per common share$  (0.73) $  10.63  $  (2.44) $  9.23   
              
    Shares used to compute basic  net income (loss) per common share   27,436     26,043     26,955     25,661   
    Shares used to compute diluted net income (loss) per common share     27,436     27,850     26,955     27,035   
              
    CONTACT: Heather Rowe
    Investor Relations
    415-365-5737
    heather.rowe@fiveprime.com
    
    Amy Kendall
    Corporate Communications
    415-365-5776
    amy.kendall@fiveprime.com
  • Achaogen Announces Leadership Promotions

    by on February 23rd, 2017

    SOUTH SAN FRANCISCO, Calif., Feb. 23, 2017 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company discovering and developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced the promotions of Blake Wise to President and Chief Operating Officer, Lee Swem, Ph.D., to Senior Vice President and Chief Scientific Officer and Zeryn Sarpangal to Senior Vice President of Corporate and People Strategy.

    “We have many talented individuals in the organization whose contributions and teamwork are essential to the significant progress we’ve made as an organization. The leadership and effort of these three individuals has been instrumental to this progress and I’m excited to recognize their impact with these promotions,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “As we expand key operating areas of the company, these promotions reflect our commitment to building a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to address the significant unmet medical need presented by MDR infections.”

    Blake Wise has been appointed President and Chief Operating Officer. He joined Achaogen in 2015 as Achaogen’s Chief Operating Officer. In his expanded role, Mr. Wise will oversee commercialization, technical operations, corporate development, investor relations, corporate communications and human resources. Prior to joining Achaogen, Mr. Wise held increasingly responsible positions at Genentech, most recently as Vice President, Cross BioOncology where he led cross-portfolio oncology initiatives, including key account management, marketing, managed markets, companion diagnostics, pipeline commercialization, and long-term oncology strategy. Mr. Wise received a Bachelor of Arts degree in Business Economics from University of California, Santa Barbara, and a Masters of Business Administration degree from the University of California, Berkeley Haas School of Business.

    Dr. Lee Swem has been promoted to Senior Vice President and Chief Scientific Officer. He joined Achaogen in 2013 as the Director of the Therapeutic Antibody Program, where he developed a state-of-the-art antibody discovery platform to rapidly identify rare functional antibodies to treat serious human infectious diseases. In 2015, he was appointed Vice President, Head of Research. Prior to Achaogen, Dr. Swem was a Scientist in the Department of Infectious Disease at Genentech where he developed programs in anti-influenza A and B, and began a small molecule anti-bacterial program. Dr. Swem received his Ph.D. from Indiana University followed by postdoctorate research at Princeton University.

    Zeryn Sarpangal has been promoted to Senior Vice President of Corporate and People Strategy. In this role, she will oversee human resources along with key aspects of corporate strategy, alliance management and non-dilutive funding. Ms. Sarpangal has been at Achaogen for more than six years and has held various roles in the organization including Sr. Director of Finance & Operations and Director of Strategic Marketing. In 2015, she was promoted to Vice President of Human Resources and Corporate Affairs. From 2012 to 2013, Ms. Sarpangal was Vice President of Finance & Operations at Identified, an HR data analytics company, that was acquired by Workday. Prior to joining Achaogen, she was an engagement manager at McKinsey & Company focused on social sector organizations and biopharmaceutical companies, and prior to that, a healthcare investment banking analyst at Goldman, Sachs & Co. Ms. Sarpangal received a Bachelor of Arts in Economics and Molecular & Cell Biology from University of California, Berkeley, and a Masters of Business Administration from the Stanford Graduate School of Business.

    About Achaogen
    Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com.

    Forward-Looking Statements
    This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACT: Contacts:
    Hans Vitzthum, Investors
    212.915.2568
    hans@lifesciadvisors.com
    
    Denise Powell, Media
    510.703.9491
    denise@redhousecomms.com
  • Radius Health Reports Fourth Quarter and Full Year 2016 Financial and Operating Results

    by on February 23rd, 2017

    US FDA PDUFA for abaloparatide-SC is March 30, 2017

    Build out of Commercial Organization to be completed in 1Q 2017

    24-month ACTIVExtend trial has concluded, Radius to report top-line results in 2Q 2017

    WALTHAM, Mass., Feb. 23, 2017 (GLOBE NEWSWIRE) — Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the fourth quarter and full year ended December 31, 2016, and provided a business update.  As of December 31, 2016, Radius had $332.4 million in cash, cash equivalents and marketable securities.

    “We continue to work closely with the U.S. Food and Drug Administration as we move towards the March 30, 2017 PDUFA for abaloparatide-SC for postmenopausal osteoporosis. Our highly experienced leadership is completing the build out of our commercial organization with seasoned talent who have demonstrated success across sales, marketing, reimbursement and distribution and are fully prepared to support a successful launch, pending favorable regulatory review,” said Robert Ward, President and Chief Executive Officer of Radius. “2017 will be a major inflection point for Radius, as we evolve towards a commercial company. We are confident that we are prepared for this change and have the talent, experience and resources required to deliver sustainable high performance.”

    Pipeline Updates

    Abaloparatide-SC

    Radius’ new drug application (NDA) in the United States for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis was accepted for filing by the FDA and granted a Prescription Drug User Fee Act (PDUFA) date of March 30, 2017. Radius’ marketing authorisation application (MAA) to the European Medicines Agency (EMA), is currently undergoing regulatory review, and we anticipate receiving an opinion from the Committee for Medicinal Products for Human Use (CHMP) in 2017.

    On February 1, 2017, results from the first six months of the recently completed 24- month ACTIVExtend trial were published in the Mayo Clinic Proceedings “Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial”. The 24-month ACTIVExtend clinical trial has completed and Radius will report the top line results in the second quarter of 2017.

    Abaloparatide-SC as a treatment for postmenopausal women with osteoporosis is an investigational product and its safety and efficacy have not been established.

    Abaloparatide-TD

    Last September, at the annual meeting of the American Association for Bone Mineral Research (ASBMR), we presented the positive results from a human replicative clinical evaluation of an optimized abaloparatide transdermal patch. These results established an important demonstration of how we have changed the pharmacokinetic profile in our program to develop a bioequivalent transdermal patch. Currently, we are focused on completing the manufacturing, scale-up, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to abaloparatide-SC. We believe that the transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, an opportunity to expand their practices to include the use of anabolic therapy.

    RAD1901

    On December 8, 2016, at the San Antonio Breast Cancer symposium we reported on the encouraging results of our ongoing Phase 1 studies of RAD1901 in advanced breast cancer. We were pleased with the clear demonstration of activity at the 400 mg dose in this heavily pretreated patient population. We plan to engage with regulatory agencies to gain alignment on defining the next steps for the program in the first half of 2017, which would include the design of a Phase 2 trial. Also in the first half of this year, we plan to report results from our completed Phase 2b trial in vasomotor symptoms.

    RAD140

    In December 2016, we submitted an investigational new drug application, or IND, to the FDA for RAD140, a selective androgen receptor modulator discovered in-house at Radius. We expect to initiate a first-in-human Phase 1 clinical trial in women with hormone receptor positive breast cancer in 2017.

    Building A Commercial Organization For Sustainable Growth

    In our evolution towards becoming a fully integrated biopharmaceutical company, our accomplished senior leadership is completing the build out of our commercial, medical and compliance organizations to support the potential commercialization of abaloparatide-SC in the United States, pending favorable regulatory review. Our sales leaders have already hired over 90% of our clinical sales specialists with a focus on identifying the most experienced team possible. The result is a sales team with substantial osteoporosis, injectable and women’s health experience, and the majority have had prior launch experience, which matches the depth of experience across our Medical Science Liaison team.

    If approved, we intend to distribute abaloparatide-SC in the United States through a network of distributors and specialty pharmacies. Under this distribution model, both the distributors and specialty pharmacies would take physical delivery of product and the specialty pharmacies would dispense the product directly to patients.

    Under the leadership of our Chief Compliance Officer, we are continuing to strengthen our compliance program in support of launch of abaloparatide-SC as part of our commitment to a strong culture of compliance and good corporate governance.

    Radius Expects the Following Upcoming Milestones

    • Abaloparatide-SC
      -FDA PDUFA date of March 30, 2017
      -Receive a CHMP opinion regarding the EMA’s review of the abaloparatide-SC MAA in 2017
      -Enter into a partnership for the potential commercialization of abaloparatide-SC prior to commercial launch
      -Report top-line results from the recently completed 24-month ACTIVExtend clinical trial in the second quarter of 2017
    • RAD1901
      -Complete ongoing Phase 1 breast cancer clinical trials
      -Engage with regulatory authorities in 1H 2017 to gain alignment on defining next steps for the program, which would include the design of a Phase 2 breast cancer trial
      -In 1H 2017, complete, and report results from, our ongoing Phase 2b vasomotor trial
    • RAD140
      -Initiate a first-in-human Phase 1 study in 2017 in women with hormone receptor positive breast cancer

    Radius Expects To Make Presentations at the Following Upcoming Conferences

    • On March 6, 2017, Radius President and CEO, Robert Ward will make a presentation and will host one-on-ones at the Cowen Conference in Boston
    • On March 24-25, 2017, at the 2017 World Congress of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), 4 scientific presentations will be made on abaloparatide titled:

      -“Effects of abaloparatide-SC on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis
      -“Abaloparatide-SC decreases vertebral, nonvertebral, major osteoporotic, and wrist fractures in a subset of postmenopausal women at high risk of fracture by FRAX score”
      -“Abaloparatide-SC for postmenopausal osteoporosis: analysis of the number needed to treat compared with teriparatide”
      -“Abaloparatide-SC significantly reduces vertebral and nonvertebral fractures and increases bone mineral density regardless of baseline risk: results from the ACTIVE phase 3 clinical trial”

    Fourth Quarter 2016 Financial Results

    For the three months ended December 31, 2016, Radius reported a net loss of $52.7 million, or $1.22 per share, as compared to a net loss of $33.2 million, or $0.77 per share, for the three months ended December 31, 2015. The increase in net loss for the three months ended December 31, 2016 as compared to the three months ended December 31, 2015 was primarily due to an increase in research and development and general and administrative expenses, partially offset by a decrease in loss on retirement of note payable, a decrease in interest expense and an increase in interest income.

    Research and development expenses for the three months ended December 31, 2016 were $25.6 million, compared to $22.2 million for the same period in 2015. This increase was primarily driven by higher research and development costs associated with the development of RAD1901 to support a Phase 1 study in metastatic breast cancer that commenced in late 2014 and a Phase 2b study in postmenopausal vasomotor symptoms that commenced in December 2015. This increase was also a result of an increase in compensation expense, including stock-based compensation, due to an increase in headcount from December 31, 2015 to December 31, 2016.

    General and administrative expenses for the three months ended December 31, 2016 were $27.5 million, compared to $11.6 million for the same period in 2015. This increase was primarily attributable to an increase in professional support costs, including the costs associated with increasing headcount and preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review. This increase was also driven by an increase in compensation expense, including stock-based compensation, due to an increase in headcount from December 31, 2015 to December 31, 2016.

    Full Year 2016 Financial Results

    For the twelve months ended December 31, 2016, Radius reported a net loss of $182.8 million, or $4.24 per share, as compared to a net loss of $101.5 million, or $2.56 per share, for the twelve months ended December 31, 2015. The increase in net loss for 2016 was primarily due to an increase in research and development expenses and general and administrative expenses, partially offset by a decrease in loss on retirement of note payable, a decrease in interest expense and an increase in interest income.

    Research and development expenses for the twelve months ended December 31, 2016 were $107.4 million, compared to $68.3 million for 2015. The increase was primarily attributable to increased compensation expense, including an increase of $3.3 million of non-cash stock-based compensation expense, due to growth in headcount from 48 research and development employees as of December 31, 2015, to 107 research and development employees as of December 31, 2016. This increase was also driven by higher contract service costs associated with the development of our investigational product candidate RAD1901 as a result of the increased clinical and manufacturing activities in 2016, as compared to 2015. These increases were partially offset by a decrease in the total professional contract service costs associated with the development of abaloparatide-SC as more subjects completed study protocol activities associated with the 24-month ACTIVExtend clinical trial in 2016, as compared to 2015.

    General and administrative expenses for the twelve months ended December 31, 2016 were $77.5 million, compared to $30.8 million for 2015. This increase was primarily due to increased professional support costs of approximately $19.4 million, including costs associated with preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review, as compared to 2015. This increase was also driven by increased compensation expense, including an increase of $8.0 million of non-cash stock-based compensation expense, due to growth in headcount from 27 general and administrative employees as of December 31, 2015, to 130 general and administrative employees as of December 31, 2016.

    For the twelve months ended December 31, 2016, the decrease in loss on retirement of note payable was $1.6 million and other expenses increased by $0.3 million. These amounts were partially offset by the increase in interest income from investments of $1.4 million and a decrease in interest expense of $1.9 million.

    As of December 31, 2016, Radius had $332.4 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance, Radius believes that, prior to the consideration of revenue from the potential future sales, subject to favorable regulatory review, of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities for not less than twelve months from the date of this press release and into 2018.

    Conference Call and Webcast

    In connection with the earnings release, Radius will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, February 23, 2017 to discuss the financial results, and give an update on the Company’s progress.

    Conference Call Information:
    Date: Thursday, February 23, 2017
    Time: 4:30 p.m. ET
    Domestic Dial-in Number: 1-877-705-6003 
    International Dial-in Number: 1-201-493-6725
    Live webcast: http://public.viavid.com/index.php?id=122846 

    For those unable to participate in the conference call or live webcast, a replay will be available until March 9, 2017 at 11:59 p.m. ET. To access the replay, dial domestic 1-844-512-2921, international 1-412-317-6671.  The replay passcode is 13654552.

    A live audio webcast of the call will also be available on the Investors section of the Company’s website, www.radiuspharm.com.  A webcast replay will be available for two weeks on the Radius website, www.radiuspharm.com.

    About Radius

    Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe and a New Drug Application (NDA) has been accepted for filing by the FDA with a PDUFA date of March 30, 2017. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius’ pipeline also includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in breast cancer. For more information, please visit www.radiuspharm.com

    About Abaloparatide

    Abaloparatide is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its potential for favorable bone building activity. 

    Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). In the fourth quarter of 2015, Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of patients with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius submitted a New Drug Application (NDA) for abaloparatide-SC to the US Food and Drug Administration (FDA) at the end of the first quarter of 2016, which has been accepted for filing with a PDUFA date of March 30, 2017. Radius also is developing an investigational abaloparatide-transdermal patch (abaloparatide-TD) based on 3M’s patented Microstructured Transdermal System technology for potential use as a treatment for osteoporosis.

    About RAD1901

    RAD1901 is a selective estrogen receptor down-regulator/degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, breast cancer. RAD1901 is currently being investigated for potential use in postmenopausal women with estrogen receptor positive (ER+), HER2-negative advanced breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

    RAD1901 also is being evaluated in a Phase 2b study at low doses for potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov.

    RAD140

    RAD140 is a nonsteroidal selective androgen receptor modulator. The androgen receptor (AR) is highly expressed in many estrogen receptor (ER)-positive, ER-negative, and triple-negative receptor breast cancers. Because of its receptor and tissue selectivity, potent activity, oral bioavailability, and long half-life, RAD140 could have clinical potential in the treatment of breast cancer. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, which is highly expressed in many breast cancers.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the progress of abaloparatide-SC in the regulatory process with the FDA and the EMA and the expected timing of potential regulatory actions, the expected timing of potential collaboration agreements, our plans for commercialization of abaloparatide-SC, the progress in the development of our product candidates, including abaloparatide-SC, abaloparatide-TD, RAD1901 and RAD140, each of the statements under the heading “Radius Expects The Following Upcoming Milestones,” upcoming events and presentations, the sufficiency of our cash, cash equivalents and marketable securities, and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-SC, abaloparatide-TD, RAD1901 and RAD140.

    These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues and may need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; any collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; risk related to manufacturing and supply; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Consolidated Balance Sheets
    (Amounts in thousands, except share and per share amounts)
     
      December 31, December 31,  
       2016   2015  
          
    ASSETS     
    Current assets:     
    Cash and cash equivalents $258,567  $  159,678  
    Restricted cash    47     –   
    Marketable securities  73,880   313,661  
    Prepaid expenses and other current assets    2,315     6,969  
    Total current assets  334,809   480,308  
    Property and equipment, net    4,922     1,897  
    Other assets    551     260  
    Total assets $340,282  $482,465  
          
    LIABILITIES AND STOCKHOLDERS’ EQUITY 
    Current liabilities:     
     Accounts payable $  6,128  $  6,228  
     Accrued expenses and other current liabilities    26,597     14,952  
    Total current liabilities    32,725     21,180  
           
    Other non-current liabilities    379     –   
    Total liabilities $  33,104  $  21,180  
    Commitments and contingencies      
    Stockholders’ equity:     
    Common stock, $.0001 par value; 200,000,000 shares authorized, 43,141,134 shares and 42,984,243 shares issued and outstanding at December 31, 2016
    and 2015, respectively
     $  4  $  4  
    Additional paid-in-capital    935,671     907,040  
    Accumulated other comprehensive income    71     5  
    Accumulated deficit    (628,568)    (445,764) 
    Total stockholders’ equity    307,178     461,285  
    Total liabilities and stockholders’ equity $  340,282  $  482,465  
          

    Consolidated Statement of Operations and Comprehensive Loss
    (Amounts in thousands, except share and per share amounts)
     
        Three Months Ended Twelve Months Ended
       December 31, December 31,
       2016   2015   2016   2015 
           
    OPERATING EXPENSES:        
    Research and development $  25,579  $  22,226  $  107,406  $  68,280 
    General and administrative    27,463     11,585     77,542     30,797 
    Loss from operations    (53,042)    (33,811)    (184,948)    (99,077)
    OTHER INCOME (EXPENSE):        
    Other income (expense), net    (119)    92     (293)    (35)
    Loss on retirement of note payable    –      –      –      (1,572)
    Interest income    441     479     2,437     1,043 
    Interest expense    –      –      –      (1,885)
    NET LOSS $  (52,720) $  (33,240) $  (182,804) $  (101,526)
    OTHER COMPREHENSIVE INCOME, NET OF TAX:        
    Unrealized (loss) gain from marketable securities    19     (94)    66     26 
    COMPREHENSIVE LOSS $  (52,701) $  (33,334) $  (182,738) $  (101,500)
    LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS – BASIC AND DILUTED: $  (52,720) $  (33,240) $  (182,804) $  (101,526)
    LOSS PER SHARE:        
    Basic and diluted $  (1.22) $  (0.77) $  (4.24) $  (2.56)
    WEIGHTED AVERAGE SHARES:        
    Basic and diluted    43,122,210     42,924,137     43,067,952     39,643,099 

     

    CONTACT: Investor Relations Contact:
    Barbara Ryan
    Email: bryan@radiuspharm.com
    Phone: 203-274-2825
    
    Media Contact:
    Lori Gorski
    Email: Lgorski@radiuspharm.com
    Phone: 617-551-4096
  • Achaogen Announces Leadership Promotions

    by on February 23rd, 2017

    SOUTH SAN FRANCISCO, Calif., Feb. 23, 2017 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company discovering and developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced the promotions of Blake Wise to President and Chief Operating Officer, Lee Swem, Ph.D., to Senior Vice President and Chief Scientific Officer and Zeryn Sarpangal to Senior Vice President of Corporate and People Strategy.

    “We have many talented individuals in the organization whose contributions and teamwork are essential to the significant progress we’ve made as an organization. The leadership and effort of these three individuals has been instrumental to this progress and I’m excited to recognize their impact with these promotions,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “As we expand key operating areas of the company, these promotions reflect our commitment to building a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to address the significant unmet medical need presented by MDR infections.”

    Blake Wise has been appointed President and Chief Operating Officer. He joined Achaogen in 2015 as Achaogen’s Chief Operating Officer. In his expanded role, Mr. Wise will oversee commercialization, technical operations, corporate development, investor relations, corporate communications and human resources. Prior to joining Achaogen, Mr. Wise held increasingly responsible positions at Genentech, most recently as Vice President, Cross BioOncology where he led cross-portfolio oncology initiatives, including key account management, marketing, managed markets, companion diagnostics, pipeline commercialization, and long-term oncology strategy. Mr. Wise received a Bachelor of Arts degree in Business Economics from University of California, Santa Barbara, and a Masters of Business Administration degree from the University of California, Berkeley Haas School of Business.

    Dr. Lee Swem has been promoted to Senior Vice President and Chief Scientific Officer. He joined Achaogen in 2013 as the Director of the Therapeutic Antibody Program, where he developed a state-of-the-art antibody discovery platform to rapidly identify rare functional antibodies to treat serious human infectious diseases. In 2015, he was appointed Vice President, Head of Research. Prior to Achaogen, Dr. Swem was a Scientist in the Department of Infectious Disease at Genentech where he developed programs in anti-influenza A and B, and began a small molecule anti-bacterial program. Dr. Swem received his Ph.D. from Indiana University followed by postdoctorate research at Princeton University.

    Zeryn Sarpangal has been promoted to Senior Vice President of Corporate and People Strategy. In this role, she will oversee human resources along with key aspects of corporate strategy, alliance management and non-dilutive funding. Ms. Sarpangal has been at Achaogen for more than six years and has held various roles in the organization including Sr. Director of Finance & Operations and Director of Strategic Marketing. In 2015, she was promoted to Vice President of Human Resources and Corporate Affairs. From 2012 to 2013, Ms. Sarpangal was Vice President of Finance & Operations at Identified, an HR data analytics company, that was acquired by Workday. Prior to joining Achaogen, she was an engagement manager at McKinsey & Company focused on social sector organizations and biopharmaceutical companies, and prior to that, a healthcare investment banking analyst at Goldman, Sachs & Co. Ms. Sarpangal received a Bachelor of Arts in Economics and Molecular & Cell Biology from University of California, Berkeley, and a Masters of Business Administration from the Stanford Graduate School of Business.

    About Achaogen
    Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com.

    Forward-Looking Statements
    This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.

    CONTACT: Contacts:
    Hans Vitzthum, Investors
    212.915.2568
    hans@lifesciadvisors.com
    
    Denise Powell, Media
    510.703.9491
    denise@redhousecomms.com
  • Cancer Genetics India Partners with CSIR-Centre for Cellular and Molecular Biology to Organize the 2nd Annual Next Generation Sequencing Conference in India

    by on February 23rd, 2017
    • Scientists at CSIR-CCMB conduct groundbreaking multi-disciplinary research in the area of modern biology and aim to promote collaborative research using advanced technologies that enable omics-based research.             

    HYDERABAD, India, Feb. 23, 2017 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in precision diagnostics for oncology, announced today that Cancer Genetics India (CG India) and CSIR-Centre for Cellular and Molecular Biology (CSIR-CCMB) have jointly organized the 2nd Annual NGS Conference taking place from 22nd to 24th of February 2017 in Hyderabad, India. The conference will bring together eminent scientists from several government research institutions that conduct cutting edge biological research using NGS technology and bioinformatics. The objective of the conference is to provide recent updates and discuss the impact of diverse yet relevant applications of NGS and bioinformatics on key research areas such as agri-genomics, onco-genomics, microbiology, and human genetics.

    The opening day of the conference coincided with the 89th birthday of Dr. P. M. Bhargava, the founder of CSIR-CCMB. On this occasion, CSIR-CCMB had organized a “Founder’s Day Celebration,” which was a great opportunity to interact with one of India’s most celebrated scientists. “We are delighted to partner with CG India to welcome all speakers and participants to hear from Dr. T Ramasamy, the distinguished speaker on this occasion,” said Dr. Rakesh Mishra, Director, CSIR-CCMB. “We are looking forward to a great conference that will promote cross-disciplinary research collaborations across India.”

    Comprehensive genomics services are central to CG India’s business model and are at the forefront of several scientific investigations carried out by scientists at CSIR-CCMB. Together, the two organizations believe that this platform will foster productive research collaborations that improve human health. CG India’s state-of-the-art facility, extensive expertise in developing customized NGS protocols, experience with routine assays, and comprehensive capabilities in analyzing NGS data will greatly support such research collaborations.

    “We are excited about this event and look forward to support and fulfill the scientific demands of leading scientists in the area of genomics, by providing high quality NGS and bioinformatics services,” said Mr. Panna Sharma, CEO and President of CGI. “As we help molecular oncologists gain novel insights in the molecular epidemiology of certain cancers in the Indian context, we look forward to developing research and clinical collaborations with leading cancer research centers and academic institutions.”

    The conference will highlight work in the area of genomics- driven findings in oncology to promote awareness about cancer related discoveries and explore how they may translate into personalized oncology applications. For more information, please visit http://cgiindia.in/NGSSymposium/.

    ABOUT CANCER GENETICS
    Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.

    The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.

    For more information, please visit or follow CGI at:
    Internet: www.cancergenetics.com
    Twitter: @Cancer_Genetics
    Facebook: Cancer Genetics, Inc. or CG India

    Forward-Looking Statements:
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.’s expectations regarding the completion, timing, pricing and size of the offering described in this press release constitute forward-looking statements.

    Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2015 and the Form 10-Q for the Quarter ended March 31, 2016 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.

    CONTACT: Contact:
    Panna Sharma
    CEO & President
    Cancer Genetics, Inc.
    Tel: 201-528-9200
    Email: panna.sharma@cgix.com
  • New Solitaire(TM) Stent Retriever Study Validates Outcomes and Real-World Application of Stroke Treatment Best Practices

    by on February 23rd, 2017

    Economic Study Finds Solitaire Stent Retriever Highly Cost-Effective

    DUBLIN and HOUSTON – Feb. 23, 2017 – Data presented today on Medtronic’s (NYSE:MDT) Solitaire stent retriever at the International Stroke Conference (ISC) in Houston demonstrate that the results from the four pivotal randomized controlled trials – SOLITAIRE(TM) FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME), Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE), EXtending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial (EXTEND IA) and Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT) – can be replicated in U.S. centers, in a pragmatic, real-world setting reconfirming the benefits of mechanical thrombectomy in patients suffering acute ischemic stroke (AIS). Study investigators presented the results from Systematic Evaluation of Patients TReated with Neurothrombectomy Devices for AcuTe Ischemic Stroke (STRATIS) Registry.

    STRATIS is the largest AIS study to date with a focus on the impact of systems of care on clinical outcomes. STRATIS examined the impact of treatment delays on patient outcomes when treated with the Solitaire stent retriever and intravenous tissue plasminogen activator (IV-tPA), if eligible. In the study, 984 patients were enrolled at 55 centers throughout the U.S.; 64 percent were treated with the Solitaire stent retriever and IV-tPA and 36 percent were treated with the Solitaire stent retriever alone. The study found that interhospital transfer was associated with significant delays to treatment and significantly lower chance of functional independence at 90 days (60.0 percent vs. 52.2 percent, p=0.02). Further, those treated via balloon guide catheter (BGC) had higher rates of functional independence at 90 days (61.8 percent vs. 50.2 percent, p=0.002) with fewer passes (1.7 vs. 2.0, p=0.0008) than patients treated via distal access catheter.

    “The STRATIS registry confirms that the outcomes from four of the global randomized clinical trials that helped to transform stroke treatment are applicable in different health systems across the U.S. with the same positive results,” said Curtis Given, M.D., co-director, Neurointerventional Services, Baptist Health, Lexington, Ky. “We are consistently seeing that access to stent retrievers reduces long-term disability in patients. We must continue to work towards a system that makes early treatment with this technology available to all patients.”
                                                                                         
    In addition to confirming real-world application, a recent study published in Stroke, Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results from the SWIFT-PRIME Trial, found that treatment with both the Solitaire stent retriever and IV-tPA is highly cost-effective and an economically dominant strategy with substantial long-term cost savings and gains in both life-expectancy and quality-adjusted life-expectancy compared to IV-tPA alone. While initial costs were higher for the Solitaire stent retriever and IV-tPA compared to IV-tPA alone ($45,761 vs. $28,578, p<0.001), costs between patient discharge and 90 days, were $4,904 per patient lower ($11,270 vs. $16,174, p=0.014) for patients treated with the Solitaire stent retriever than patients treated with IV-tPA alone due to significant reductions in rehospitalization, rehabilitation-related, and long-term nursing home costs. Finally, treatment with the Solitaire stent retriever was associated with cost savings of $23,203 per patient over a lifetime.

    “The cost-effectiveness data shows that despite higher initial treatment costs, in the long run, patients who receive stent retriever therapy with the Solitaire stent retriever spend less time in the hospital, less time in rehabilitation, and less time in nursing home care after an acute ischemic stroke. Patients have faster and complete recoveries, and the healthcare system saves money overall,” said Jeffrey L. Saver, M.D., FAHA, FAAN, FANA, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles and director, UCLA Comprehensive Stroke Center.

    The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, helping to restore blood flow and remove large blood clots causing AIS.

    “Medtronic continues to provide ground-breaking data that shows the impact and now, long-term cost savings of our Solitaire stent retriever, the most studied of this class of devices,” said Stacey Pugh, vice president and general manager of Medtronic’s Neurovascular business, which is part of the Restorative Therapies Group. “As the pioneer of stent retriever technology, we are committed to working with hospitals, providers and organizations such as the American Heart Association/American Stroke Association (AHA/ASA) to continue to bring the most effective stroke treatments to the patients who need it most.”

    According to the American Heart Association/American Stroke Association (AHA/ASA), stroke is the fifth leading cause of death in the U.S. and a leading cause of disability. In June 2015, the AHA/ASA published new stroke treatment guidelines that recommended the use of stent retriever technology – such as the Solitaire stent retriever device – in conjunction with IV rtPA/alteplase as a first-line treatment for eligible patients.

    About Medtronic
    Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

    Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

    -end-

     

     

    Contacts:
    Sara Thatcher
    Public Relations
    +1-901-338-9212

    Ryan Weispfenning
    Investor Relations
    +1-763-505-4626

  • Abiomed Surpasses 50,000 Impella® Patients Treated in the United States

    by on February 23rd, 2017

    DANVERS, Mass., Feb. 23, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced that it has supported more than 50,000 patients in the U.S. with its Impella® line of heart pumps. Impella heart pumps enable minimally invasive treatment for high risk heart failure patients who might otherwise have no treatment options.

    The 50,000th patient supported with an Impella device was treated by Dr. Subhash Banerjee, Professor of Medicine at the University of Texas Southwest Medical Center and Chief of Cardiology at the Dallas VA Medical Center. “Impella heart pumps enable percutaneous treatment options for high risk heart failure patients who have been turned-down for surgery,” said Dr. Banerjee, who performed the procedure with the Impella CP®. “Hemodynamic stability is essential to treating these types of high risk patients and with the support of an Impella device, we are able to safely perform complete and complex coronary interventions on patients that might not have been treated previously.”

    Impella heart pumps are the first and only temporary percutaneous ventricular support devices that are FDA-approved as safe and effective for use in high-risk percutaneous coronary interventions (PCI) as well as the treatment of cardiogenic shock, a life-threatening condition that typically occurs during or after a heart attack, or post-cardiopulmonary bypass surgery.

    Heart failure and coronary heart disease are the number one cause of death in the United States, causing one out of every three deaths, or nearly 900,000 deaths each year.1 This heart failure epidemic currently affects 5.7 million Americans and by the year 2030 that number is expected to grow by 46 percent.1,2   While, to date, over 50,000 patients have been treated with Impella in the United States, Impella is currently used in only 1 percent of PCIs and in less than 10 percent of patients experiencing an AMI complicated by cardiogenic shock. As a result, tens of thousands of patients remain undertreated and potentially unaware of the procedural options Impella can afford physicians.

    In Detroit, an unprecedented collaboration between metro cardiologists across five hospitals is providing an early indication of the potential to improve heart attack survival rates using Impella early in the cardiogenic shock spiral.

    “People are aware that heart disease is the number one killer, but they may not know what a major role coronary artery disease plays in the development of cardiogenic shock, which has had the same devastating mortality rate for 30 years in spite of the major advances in cardiac care,” said William W. O’Neill, M.D., director of the Center for Structural Heart Disease at Henry Ford Health System. “In our collaborative approach crossing the usual hospital system boundaries, we have utilized a common protocol since July 2016 in an effort to improve the outcomes for our entire community.”  

    Continued Dr. O’Neill: “In reviewing the observational data generated from treating a small group of 30 patients, we continue to develop and prove the hypothesis that Impella, used early, can be an effective tool to improve survival of cardiogenic shock and enable patients to keep their own hearts after events that may otherwise have resulted in transplant, chronic heart failure, or death.” These results and other data observed in Abiomed’s IQ Assurance Database will be discussed in March at the annual American College of Cardiology Scientific Sessions in Washington, D.C.

    The Impella pumps offer the unique ability to both stabilize the patient’s hemodynamics before or during a percutaneous coronary intervention (PCI) procedure and unload the heart, which allows the muscle to rest and potentially recover its native function. Impella is now recognized by multiple medical guidelines and regulatory bodies worldwide and is supported in published expert consensus documents and nearly 400 clinical publications. Heart recovery is the ideal option for patient quality of life and, as documented in several clinical papers, has the ability to save costs for the healthcare system3,4,5.

    In 2014, a study analyzed all adult patients receiving short-term mechanical circulatory support (MCS) in the United States from 2004 to 2011 (12,000 patients) using the Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project. The study showed the use of short term mechanical support in the U.S. had reduced hospital mortality rates while also reducing hospital costs.6 Additionally, Impella has been shown to reduce length of stay7, reduce readmission rates8 and has been proven cost effective in multiple clinical studies.9 

    “Treating 50,000 patients in the United States is an incredible milestone for the Company, as it reflects our unyielding commitment to addressing the significant unmet need for advanced heart failure patients who might otherwise have no treatment options,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “By working to change the standard of care and building the field of heart recovery, it is our goal to continue to improve patient outcomes and increase access to this life-changing innovation.”

    Founded in 1981 in Danvers, Massachusetts, Abiomed develops and manufactures Impella, a line of the world’s smallest heart pumps that are inserted minimally invasively in a hospital catheterization lab without the need for surgery. The Impella heart pumps are in over 1,200 U.S. hospitals and are used in 98% of the top U.S. heart hospitals.

    ABOUT IMPELLA
    The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5 and Impella CP® are also approved to treat certain advanced heart failure patients undergoing elective percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed’s right-side heart pump, the Impella RP®, is approved to treat certain patients experiencing right heart failure.

    To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

    The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries. Impella 2.5, Impella 5.0, and Recovering hearts. Saving lives. are trademarks of Abiomed, Inc.
                           
    ABOUT ABIOMED
    Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.

    FORWARD-LOOKING STATEMENTS
    This release contains forward-looking statements, including statements regarding development of Abiomed’s existing and new products, the Company’s progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

    1. American Heart Association: Heart Disease and Stroke Statistics; 2015 Update
    2. Cardiovascular Business: Heart failure expected to steadily rise through 2030 ; Jan 30, 2017 http://www.cardiovascularbusiness.com/topics/heart-failure/heart-failure-expected-steadily-rise-through-2030
    3. Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: Cost-Effectiveness in the Emergent Setting. Catheter Cardiovasc Interv. 2014 May 1;83(6):E183-92.
    4. Cheung A, Danter M, Gregory D. TCT-385 Comparative Economic Outcomes in Cardiogenic Shock Patients Managed with the Minimally Invasive Impella or Extracorporeal Life Support. J Am Coll Cardiol. 2012;60(17_S):. doi:10.1016/j.jacc.2012.08.413.
    5. Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini B, O’Neill W. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013 Mar;6(2):88-99
    6. Stretch et al, Journal of the American College of Cardiology, 2014
    7. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Maini B, et al. Catheter Cardiovasc Interv. 2014;83(6):E183-E192.
    8. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Gregory D, Scotti DJ. J Manag Care Med. 2013:16(1):61-69; Maini B, et al. Expert Rev Pharmacoecon Outcomes Res. 2014;14(3):403-416. ; Gregory DA, et al. J Am Coll Cardiol. 2014;63(12_S):A925.
    9. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Maini B, et al. Catheter Cardiovasc Interv. 2014;83(6):E183-E192; Roos JB, et al. J Med Econ. 2013;16(3):381-390.
    CONTACT: For further information please contact: 
    
    Ingrid Goldberg
    Director, Investor Relations
    978-646-1590
    igoldberg@abiomed.com
    
    Adrienne Smith
    Senior Director, Public Relations and Corporate Communications
    978-646-1553
    adsmith@abiomed.com
  • Abiomed Surpasses 50,000 Impella® Patients Treated in the United States

    by on February 23rd, 2017

    DANVERS, Mass., Feb. 23, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced that it has supported more than 50,000 patients in the U.S. with its Impella® line of heart pumps. Impella heart pumps enable minimally invasive treatment for high risk heart failure patients who might otherwise have no treatment options.

    The 50,000th patient supported with an Impella device was treated by Dr. Subhash Banerjee, Professor of Medicine at the University of Texas Southwest Medical Center and Chief of Cardiology at the Dallas VA Medical Center. “Impella heart pumps enable percutaneous treatment options for high risk heart failure patients who have been turned-down for surgery,” said Dr. Banerjee, who performed the procedure with the Impella CP®. “Hemodynamic stability is essential to treating these types of high risk patients and with the support of an Impella device, we are able to safely perform complete and complex coronary interventions on patients that might not have been treated previously.”

    Impella heart pumps are the first and only temporary percutaneous ventricular support devices that are FDA-approved as safe and effective for use in high-risk percutaneous coronary interventions (PCI) as well as the treatment of cardiogenic shock, a life-threatening condition that typically occurs during or after a heart attack, or post-cardiopulmonary bypass surgery.

    Heart failure and coronary heart disease are the number one cause of death in the United States, causing one out of every three deaths, or nearly 900,000 deaths each year.1 This heart failure epidemic currently affects 5.7 million Americans and by the year 2030 that number is expected to grow by 46 percent.1,2   While, to date, over 50,000 patients have been treated with Impella in the United States, Impella is currently used in only 1 percent of PCIs and in less than 10 percent of patients experiencing an AMI complicated by cardiogenic shock. As a result, tens of thousands of patients remain undertreated and potentially unaware of the procedural options Impella can afford physicians.

    In Detroit, an unprecedented collaboration between metro cardiologists across five hospitals is providing an early indication of the potential to improve heart attack survival rates using Impella early in the cardiogenic shock spiral.

    “People are aware that heart disease is the number one killer, but they may not know what a major role coronary artery disease plays in the development of cardiogenic shock, which has had the same devastating mortality rate for 30 years in spite of the major advances in cardiac care,” said William W. O’Neill, M.D., director of the Center for Structural Heart Disease at Henry Ford Health System. “In our collaborative approach crossing the usual hospital system boundaries, we have utilized a common protocol since July 2016 in an effort to improve the outcomes for our entire community.”  

    Continued Dr. O’Neill: “In reviewing the observational data generated from treating a small group of 30 patients, we continue to develop and prove the hypothesis that Impella, used early, can be an effective tool to improve survival of cardiogenic shock and enable patients to keep their own hearts after events that may otherwise have resulted in transplant, chronic heart failure, or death.” These results and other data observed in Abiomed’s IQ Assurance Database will be discussed in March at the annual American College of Cardiology Scientific Sessions in Washington, D.C.

    The Impella pumps offer the unique ability to both stabilize the patient’s hemodynamics before or during a percutaneous coronary intervention (PCI) procedure and unload the heart, which allows the muscle to rest and potentially recover its native function. Impella is now recognized by multiple medical guidelines and regulatory bodies worldwide and is supported in published expert consensus documents and nearly 400 clinical publications. Heart recovery is the ideal option for patient quality of life and, as documented in several clinical papers, has the ability to save costs for the healthcare system3,4,5.

    In 2014, a study analyzed all adult patients receiving short-term mechanical circulatory support (MCS) in the United States from 2004 to 2011 (12,000 patients) using the Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project. The study showed the use of short term mechanical support in the U.S. had reduced hospital mortality rates while also reducing hospital costs.6 Additionally, Impella has been shown to reduce length of stay7, reduce readmission rates8 and has been proven cost effective in multiple clinical studies.9 

    “Treating 50,000 patients in the United States is an incredible milestone for the Company, as it reflects our unyielding commitment to addressing the significant unmet need for advanced heart failure patients who might otherwise have no treatment options,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “By working to change the standard of care and building the field of heart recovery, it is our goal to continue to improve patient outcomes and increase access to this life-changing innovation.”

    Founded in 1981 in Danvers, Massachusetts, Abiomed develops and manufactures Impella, a line of the world’s smallest heart pumps that are inserted minimally invasively in a hospital catheterization lab without the need for surgery. The Impella heart pumps are in over 1,200 U.S. hospitals and are used in 98% of the top U.S. heart hospitals.

    ABOUT IMPELLA
    The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5 and Impella CP® are also approved to treat certain advanced heart failure patients undergoing elective percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed’s right-side heart pump, the Impella RP®, is approved to treat certain patients experiencing right heart failure.

    To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

    The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries. Impella 2.5, Impella 5.0, and Recovering hearts. Saving lives. are trademarks of Abiomed, Inc.
                           
    ABOUT ABIOMED
    Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.

    FORWARD-LOOKING STATEMENTS
    This release contains forward-looking statements, including statements regarding development of Abiomed’s existing and new products, the Company’s progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

    1. American Heart Association: Heart Disease and Stroke Statistics; 2015 Update
    2. Cardiovascular Business: Heart failure expected to steadily rise through 2030 ; Jan 30, 2017 http://www.cardiovascularbusiness.com/topics/heart-failure/heart-failure-expected-steadily-rise-through-2030
    3. Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: Cost-Effectiveness in the Emergent Setting. Catheter Cardiovasc Interv. 2014 May 1;83(6):E183-92.
    4. Cheung A, Danter M, Gregory D. TCT-385 Comparative Economic Outcomes in Cardiogenic Shock Patients Managed with the Minimally Invasive Impella or Extracorporeal Life Support. J Am Coll Cardiol. 2012;60(17_S):. doi:10.1016/j.jacc.2012.08.413.
    5. Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini B, O’Neill W. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013 Mar;6(2):88-99
    6. Stretch et al, Journal of the American College of Cardiology, 2014
    7. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Maini B, et al. Catheter Cardiovasc Interv. 2014;83(6):E183-E192.
    8. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Gregory D, Scotti DJ. J Manag Care Med. 2013:16(1):61-69; Maini B, et al. Expert Rev Pharmacoecon Outcomes Res. 2014;14(3):403-416. ; Gregory DA, et al. J Am Coll Cardiol. 2014;63(12_S):A925.
    9. Gregory D, et al. Am Health Drug Benefits. 2013;6(2):88-99; Maini B, et al. Catheter Cardiovasc Interv. 2014;83(6):E183-E192; Roos JB, et al. J Med Econ. 2013;16(3):381-390.
    CONTACT: For further information please contact: 
    
    Ingrid Goldberg
    Director, Investor Relations
    978-646-1590
    igoldberg@abiomed.com
    
    Adrienne Smith
    Senior Director, Public Relations and Corporate Communications
    978-646-1553
    adsmith@abiomed.com
  • Survey highlights interest in diet’s effects on RA

    by on February 23rd, 2017

    FROM ARTHRITIS CARE & RESEARCH Nearly one-quarter of patients with long-standing rheumatoid arthritis who participated in a recent survey reported that their diets affect their RA symptoms. Of 217 participants with a median disease duration of 17 years, 52 (24%) reported that certain foods either improve or worsen symptoms. Foods most commonly associated with improved […]

  • A familiar face

    by on February 23rd, 2017

    A friend of mine recently fell and sustained a complex wrist fracture. She is more than a month post injury, and her forearm, with all its external hardware, looks like an 11-year-old’s science project gone horribly wrong. As she related the story of her fall, the surgery, and her recovery, she mentioned that, since the […]

  • Pilot trial of first in kind biologic shows RA treatment potential

    by on February 23rd, 2017

    FROM ANNALS OF THE RHEUMATIC DISEASES The novel biologic mavrilimumab that targets the GM-CSF pathway has shown therapeutic potential in the treatment of rheumatoid arthritis in a proof-of-concept trial, particularly in patients who have failed to respond to biologics that target other pathways. Writing in the Annals of the Rheumatic Diseases, researchers led by Gerd […]

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