• Castle Rock Veterinarian Brekke Veterinary Clinic Reminds Pet Owners About Heartworm Risk During Heartworm Awareness Month

    by on April 23rd, 2017

    CASTLE ROCK, Colo., April 23, 2017 (GLOBE NEWSWIRE) — April is Heartworm Awareness Month for pets and Brekke Veterinary Clinic of Castle Rock is taking this opportunity to remind area pet owners about the risks and hazards of heartworm. These risks can become particularly pronounced during the spring season when mosquitoes become more active. 

    Dogs, in particular, are at high risk for heartworm, and the disease is fatal for many of them if left untreated. An estimated one million dogs in the U.S. currently have heartworm disease, according to the American Heartworm Society. Heartworm is also a threat to cats who venture outdoors.

    Heartworms are spread by infected mosquitoes, and they take residence within the hearts, lungs and pulmonary arteries of animals that have been bitten. The worms can grow up to one foot long and multiply within the body. Heartworm can eventually lead to heart failure as well as damage to the other organs in the body.

    Fortunately, heartworm is preventable. If detected after it has spread, the pet will require extensive treatment including X-rays, vaccinations, and close monitoring of their progress. However, the prevention of heartworm disease can be as simple as giving pets a monthly medication.

    Most pet owners find heartworm prevention costs to be a small price to pay for their pet’s health and safety. By contrast, treating an advanced case of heartworm can be costly in terms of the pet’s suffering and loss of quality of life.

    It is essential to stay on top of heartworm prevention in dogs and cats. Again, the spring season is “heartworm season,” but infected mosquitoes can potentially strike pets any time of the year, especially in temperate climates.      

    Castle Rock Veterinarian Brekke Veterinary Clinic carries a number of effective solutions for heartworm prevention, including Interceptor® Plus monthly flavored tablets. A simple heartworm blood test is recommended annually for early detection. In addition to heartworm prevention, Brekke Veterinary Clinic also provides a full suite of veterinary services including full exams, preventative care, surgery, cardiology, internal medicine, oncology, dermatology, dentistry, emergency care, and more.

    Head Veterinarian Dr. Jay Brekke, DVM says, “We know that people regard their pets as members of the family, and we treat every animal with care and respect. Heartworm is a very serious issue, and we encourage all pet owners to take the easy steps required to help prevent it. April is Heartworm Awareness Month, so this is the perfect time to promote awareness about this important pet health issue.”

    Those in the public who wish to learn more about the services available at Brekke Veterinary Clinic, or those who wish to book an appointment, may do so by calling (303) 474-4260. Additional information about the practice can also be accessed on their website at http://brekkevet.com/.

    CONTACT: Brekke Veterinary Clinic 
    856 W Happy Canyon Rd #120 
    Castle Rock, CO 80108
    (303) 474-4260
  • Study underscores antipsoriatic effect of gastric bypass surgery

    by on April 22nd, 2017

    From JAMA Surgery Gastric bypass surgery was associated with more than a 50% drop in baseline rates of psoriasis, and with about a 70% decrease in the incidence of psoriatic arthritis, investigators reported. In contrast, gastric banding did not appear to affect baselines rates of either of these autoimmune conditions, Alexander Egeberg, MD, of Herlev […]

  • EHR price alert doesn’t reduce lab orders

    by on April 22nd, 2017

    FROM SGIM 2017 Displaying Medicare allowable fees in the electronic health record at the time of order entry did not significantly reduce the number of inpatient lab tests at three Philadelphia hospitals. In a study involving 98,529 patients and 142,921 admissions, Medicare payment information popped up randomly in the EHR when standard tests including complete […]

  • HIV demographics shifting in U.S.

    by on April 22nd, 2017

    FROM AIDS CARE (FRONTLINE MEDICAL NEWS) The number of people living with diagnosed HIV in the United States will increase to 1,232,054 by 2045, up from 917,294 in 2013, according to projections based on the National HIV Surveillance System and U.S. census data. The number of people with HIV over age 55 will more than […]

  • Ebola research update: March 2017

    by on April 22nd, 2017

    The struggle to defeat Ebola virus disease continues globally, although it may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look. Malaria parasite coinfections were common in patients presenting […]

  • ACA brought down veterans’ uninsured rate

    by on April 22nd, 2017

    The percentage of uninsured veterans dropped by almost 40% in the first 2 years after the Affordable Care Act’s major coverage provisions were implemented, according to a report from the Robert Wood Johnson Foundation and the Urban Institute. In 2015, 5.9% of the almost 9.4 million veterans aged 19-64 years were uninsured, down from 9.6% […]

  • UPDATED: Cellectar Biosciences Strengthens Management Team with Appointment of John Friend, M.D. as Chief Medical Officer

    by on April 21st, 2017

    MADISON, Wis., April 21, 2017 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces it has appointed John Friend, II, M.D. as vice president and chief medical officer effective April 17, 2017.

    “Cellectar has accelerated and expanded its research and development program to include multiple clinical trials for our lead product candidate CLR 131, as well as the active preclinical development of additional compounds utilizing our PDC platform,” said Jim Caruso, president and CEO of Cellectar Biosciences. “John’s depth of drug development experience in the biopharmaceutical industry, specifically, advancing drugs from preclinical stage through clinical studies, as well as successful oversight of the regulatory process, precisely meets our current need in helming our PDC programs and we look forward to benefitting from his leadership.”

    Dr. Friend, age 47, brings 15 years of global drug development expertise and general management experience in oncology, inflammation, endocrine/metabolism, and pain management to Cellectar.  Prior to joining the company, John spent more than seven years at Helsinn Therapeutics leading its research and development division.  Most recently he served as senior vice president of Medical and Scientific Affairs at Helsinn, building the non-clinical, clinical, medical and regulatory affairs teams to lead multiple global franchises from early product development to market commercialization. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.  After obtaining an undergraduate degree in Chemistry from Southern Methodist University, John earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS).  He completed post-graduate residency program in family medicine and subsequently served as clinical director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina.

    Grant of Inducement Option

    Cellectar has granted to Dr. Friend, effective as of his first day of employment with Cellectar, 100,000 shares of Cellectar’s common stock vesting in equal annual installments over three years.  This grant was approved by both the Compensation Committee of Cellectar’s Board of Directors and the full Board of Directors and made as an inducement material to Dr. Friend’s entering into employment with Cellectar as contemplated by Nasdaq Listing Rule 5635(c)(4).

    About Cellectar Biosciences, Inc.
    Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma, as well as a Phase II clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical-stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com.

    This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2016. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

    CONTACT: CONTACT: 
    Jules Abraham
    JQA Partners, Inc.
    917-885-7378
    jabraham@jqapartners.com
  • UPDATED: Cellectar Biosciences Strengthens Management Team with Appointment of John Friend, M.D. as Chief Medical Officer

    by on April 21st, 2017

    MADISON, Wis., April 21, 2017 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces it has appointed John Friend, II, M.D. as vice president and chief medical officer effective April 17, 2017.

    “Cellectar has accelerated and expanded its research and development program to include multiple clinical trials for our lead product candidate CLR 131, as well as the active preclinical development of additional compounds utilizing our PDC platform,” said Jim Caruso, president and CEO of Cellectar Biosciences. “John’s depth of drug development experience in the biopharmaceutical industry, specifically, advancing drugs from preclinical stage through clinical studies, as well as successful oversight of the regulatory process, precisely meets our current need in helming our PDC programs and we look forward to benefitting from his leadership.”

    Dr. Friend, age 47, brings 15 years of global drug development expertise and general management experience in oncology, inflammation, endocrine/metabolism, and pain management to Cellectar.  Prior to joining the company, John spent more than seven years at Helsinn Therapeutics leading its research and development division.  Most recently he served as senior vice president of Medical and Scientific Affairs at Helsinn, building the non-clinical, clinical, medical and regulatory affairs teams to lead multiple global franchises from early product development to market commercialization. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.  After obtaining an undergraduate degree in Chemistry from Southern Methodist University, John earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS).  He completed post-graduate residency program in family medicine and subsequently served as clinical director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina.

    Grant of Inducement Option

    Cellectar has granted to Dr. Friend, effective as of his first day of employment with Cellectar, 100,000 shares of Cellectar’s common stock vesting in equal annual installments over three years.  This grant was approved by both the Compensation Committee of Cellectar’s Board of Directors and the full Board of Directors and made as an inducement material to Dr. Friend’s entering into employment with Cellectar as contemplated by Nasdaq Listing Rule 5635(c)(4).

    About Cellectar Biosciences, Inc.
    Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma, as well as a Phase II clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical-stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com.

    This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2016. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

    CONTACT: CONTACT: 
    Jules Abraham
    JQA Partners, Inc.
    917-885-7378
    jabraham@jqapartners.com
  • Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe*

    by on April 21st, 2017
    • Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases.  Biosimilar rituximab also recommended to treat blood cancers
    • Comprehensive data packages, confirming Sandoz biosimilars rituximab and etanercept match their respective reference medicines, were the basis for CHMP decisions
    • Subject to EC** approval, Sandoz market leadership position extended as the only company to have five approved biosimilars in Europe[1]

    Holzkirchen, April 21, 2017 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.

    “We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios”.

    If approved, Sandoz biosimilar rituximab may be used in all indications of the reference medicine, MabThera®***, which are non-Hodgkin’s lymphoma – follicular lymphoma and diffuse large B-cell lymphoma – chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

    If Sandoz biosimilar etanercept is approved, it may be used in all indications of the reference medicine, Enbrel®****, which are rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, Juvenile idiopathic arthritis and pediatric plaque psoriasis.

    The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical – including pharmacokinetic/pharmacodynamic – data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines[2-8].

    • Studies within the biosimilar rituximab development program included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA)[7] and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL)[8].
    • The biosimilar etanercept development program included an innovative Phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY), which included three treatment switches between the reference medicine and biosimilar etanercept[4].

    Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and, in addition to biosimilar rituximab and etanercept (ErelziTM approved in 2016 by the FDA), plans to launch three more biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

    Disclaimer
    The foregoing release contains forward-looking statements that can be identified by words such as “proposed,” “recommended,” “positive CHMP opinions,” “positive opinions,” “recommending,” “potential,” “recommendations,” “will,” “may,” “committed,” “pipeline,” “plans,” “launch,” “well-positioned,” or similar terms, or by express or implied discussions regarding potential marketing approvals or labeling for biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar rituximab, biosimilar etanercept, and the other products in the Sandoz biosimilar pipeline. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar rituximab or biosimilar etanercept will be approved for all indications included in the reference products’ respective labels. Nor can there be any guarantee that biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management’s expectations regarding biosimilar rituximab, biosimilar etanercept, and such other Sandoz biosimilar pipeline products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of biosimilar rituximab or biosimilar etanercept; global trends toward health care cost containment, including government, payor and general public pricing pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling biosimilar rituximab, biosimilar etanercept, or its other biosimilar products; the particular prescribing preferences of physicians and patients; general economic and industry conditions; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

    About Sandoz
    Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

    * European Economic Area (EEA). The European Economic Area (EEA) provides for the free movement of persons, goods, services and capital within the internal market of the European Union (EU) between its 28 member states, as well as three of the four member states of the European Free Trade Association (EFTA): Iceland, Liechtenstein and Norway.
    ** European Commission
    *** MabThera® is a registered trademark of F. Hoffmann-La Roche AG
    **** Enbrel® is a registered trademark of Pfizer in Europe and Amgen in the US.

    References
    [1] European Medicines Agency 2017. The European public assessment reports are published on the European Medicines Agency website (cited 03 March 2017). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
    [2] Visser J et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs. 2013;27:495-507.
    [3] Da Silva A et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014;55:1609-1617.
    [4] Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead of print].
    [5] von Richter O et al. GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its auto-injector device with pre-filled syringes. Br J Clin Pharmacol. 2016 Oct 27. doi: 10.1111/bcp.13170. [Epub ahead of print]
    [6] Hofmann HP et al. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®). Exp Opin Biol Ther. 2016;16:1185-95.
    [7] Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222.
    [8] Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma ASH annual meeting, 3-6 December 2016, San Diego, USA:1809.

    # # #

    For further information, contact:

    Novartis Media Relations
    Central media line: +41 61 324 2200
    E-mail: media.relations@novartis.com

    Eric Althoff
    Novartis Global Media Relations
    +41 61 324 7999 (direct)
    +41 79 593 4202 (mobile)
    eric.althoff@novartis.com

    Duncan Cantor
    Sandoz Global Communications
    +49 170 650 6067
    duncan.cantor@sandoz.com

    Tara Lanigan
    Sandoz Global Communications
    +49 172 8295 276
    tara.lanigan@sandoz.com

    Chris Lewis
    Sandoz Global Communications
    +49 8024 476 1906
    chris.lewis@sandoz.com

    Novartis Investor Relations
    Central investor relations line: +41 61 324 7944
    E-mail: investor.relations@novartis.com

    Central   North America  
    Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
    Pierre-Michel Bringer +41 61 324 1065    
    Thomas Hungerbuehler +41 61 324 8425    
    Isabella Zinck +41 61 324 7188    

    Attachments:

    http://www.globenewswire.com/NewsRoom/AttachmentNg/f8110fab-cdd4-47b3-940c-0671b7ec7d80

  • Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe*

    by on April 21st, 2017
    • Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases.  Biosimilar rituximab also recommended to treat blood cancers
    • Comprehensive data packages, confirming Sandoz biosimilars rituximab and etanercept match their respective reference medicines, were the basis for CHMP decisions
    • Subject to EC** approval, Sandoz market leadership position extended as the only company to have five approved biosimilars in Europe[1]

    Holzkirchen, April 21, 2017 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.

    “We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios”.

    If approved, Sandoz biosimilar rituximab may be used in all indications of the reference medicine, MabThera®***, which are non-Hodgkin’s lymphoma – follicular lymphoma and diffuse large B-cell lymphoma – chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

    If Sandoz biosimilar etanercept is approved, it may be used in all indications of the reference medicine, Enbrel®****, which are rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, Juvenile idiopathic arthritis and pediatric plaque psoriasis.

    The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical – including pharmacokinetic/pharmacodynamic – data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines[2-8].

    • Studies within the biosimilar rituximab development program included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA)[7] and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL)[8].
    • The biosimilar etanercept development program included an innovative Phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY), which included three treatment switches between the reference medicine and biosimilar etanercept[4].

    Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars, and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and, in addition to biosimilar rituximab and etanercept (ErelziTM approved in 2016 by the FDA), plans to launch three more biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

    Disclaimer
    The foregoing release contains forward-looking statements that can be identified by words such as “proposed,” “recommended,” “positive CHMP opinions,” “positive opinions,” “recommending,” “potential,” “recommendations,” “will,” “may,” “committed,” “pipeline,” “plans,” “launch,” “well-positioned,” or similar terms, or by express or implied discussions regarding potential marketing approvals or labeling for biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from biosimilar rituximab, biosimilar etanercept, and the other products in the Sandoz biosimilar pipeline. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, biosimilar rituximab or biosimilar etanercept will be approved for all indications included in the reference products’ respective labels. Nor can there be any guarantee that biosimilar rituximab, biosimilar etanercept, or any of the other products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management’s expectations regarding biosimilar rituximab, biosimilar etanercept, and such other Sandoz biosimilar pipeline products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of biosimilar rituximab or biosimilar etanercept; global trends toward health care cost containment, including government, payor and general public pricing pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling biosimilar rituximab, biosimilar etanercept, or its other biosimilar products; the particular prescribing preferences of physicians and patients; general economic and industry conditions; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

    About Sandoz
    Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

    * European Economic Area (EEA). The European Economic Area (EEA) provides for the free movement of persons, goods, services and capital within the internal market of the European Union (EU) between its 28 member states, as well as three of the four member states of the European Free Trade Association (EFTA): Iceland, Liechtenstein and Norway.
    ** European Commission
    *** MabThera® is a registered trademark of F. Hoffmann-La Roche AG
    **** Enbrel® is a registered trademark of Pfizer in Europe and Amgen in the US.

    References
    [1] European Medicines Agency 2017. The European public assessment reports are published on the European Medicines Agency website (cited 03 March 2017). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
    [2] Visser J et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs. 2013;27:495-507.
    [3] Da Silva A et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014;55:1609-1617.
    [4] Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead of print].
    [5] von Richter O et al. GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its auto-injector device with pre-filled syringes. Br J Clin Pharmacol. 2016 Oct 27. doi: 10.1111/bcp.13170. [Epub ahead of print]
    [6] Hofmann HP et al. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®). Exp Opin Biol Ther. 2016;16:1185-95.
    [7] Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222.
    [8] Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma ASH annual meeting, 3-6 December 2016, San Diego, USA:1809.

    # # #

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