NEWTON, Mass., Jan. 04, 2016 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ:CHMA), a late-stage biopharmaceutical company developing Mycapssa™ (octreotide capsules), an investigational oral drug for the maintenance therapy of adult patients with the orphan disease acromegaly, today announced two additions to its management team.
Tara McCarthy has joined Chiasma as Senior Vice President and General Counsel, responsible for legal strategy and compliance. Steven Vickers has joined Chiasma as Vice President of Sales and is responsible for building and leading Chiasma’s anticipated U.S. sales effort, beginning with the potential mid-2016 launch of Mycapssa™. In June 2015, Chiasma submitted a New Drug Application (NDA) for Mycapssa™ for the maintenance treatment of adults with acromegaly, and the NDA is pending U.S. Food and Drug Administration (FDA) approval with an April 15, 2016 Prescription Drug User Fee Act (PDUFA) date.
“During the course of the past year, we have focused on building a senior management team that would enable us to transition Chiasma from a development-stage organization to a commercial-ready company,” said Mark Leuchtenberger, Chief Executive Officer of Chiasma. “With the additions of Steven and Tara, we have accomplished this goal and are readying the entire organization for what we believe will be an exciting 2016. Both of these individuals bring to Chiasma a wealth of commercial launch experience, and we believe their contributions will be invaluable as we seek approval for Mycapssa™ here in the U.S. and advance our clinical and regulatory work in Europe.”
Ms. McCarthy most recently served as the vice president of commercial law for Vertex Pharmaceuticals, building a global commercial legal team and helping to launch its INCIVEK®, KALYDECO® and ORKAMBI® product lines in multiple countries, including the U.S. Prior to Vertex, she served as senior corporate counsel at Genzyme Corporation, where she was responsible for the company’s Renal and Endocrinology business unit and its RENAGEL®/RENVELA®, HECTOROL® and THYROGEN® product lines. Before joining Genzyme, Ms. McCarthy served as assistant general counsel and director of investor relations for Health Dialog Services Corporation. She earned her J.D. from the University of Michigan Law School and a B.A. from the University of Massachusetts at Amherst.
“With a strong proprietary technology foundation and the potential for a near-term product approval, Chiasma is well positioned in the rare disease space,” said Ms. McCarthy. “I look forward to working with an excellent management team to prepare the company for success in the next phase of its development.”
Mr. Vickers spent the past four years with Onyx Pharmaceuticals, which is now a subsidiary of Amgen. During this time, he served as senior national sales director for the company’s hematology business, leading the successful launch of Onyx’s KYPROLIS™ and BLINCYTO™ product lines. Prior to joining Onyx, Mr. Vickers served as a sales leader at Millennium Pharmaceuticals, Eisai Incorporated and Chiron Corporation. He earned his M.B.A. in Corporate Finance and Marketing from the University of Southern California and a B.S. from the University of California at Berkeley.
“I am thrilled to join Chiasma at this important stage,” said Mr. Vickers. “During the coming months, we will focus on building a sales and support infrastructure in a diligent, yet strategic manner to enable long-term commercial success following the potential approval of Mycapssa™.”
About Chiasma
Chiasma is a late-stage biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is Mycapssa™ (octreotide capsules), a new investigational drug for the orphan condition acromegaly, developed with Chiasma’s Transient Permeability Enhancer (TPE®) technology to facilitate gastrointestinal absorption of unmodified drug into the bloodstream safely. Mycapssa™ has not been approved for use in any jurisdiction. Using TPE® technology, Chiasma is evaluating additional proteins, peptides and small molecule drugs that are currently only available by injection, but could potentially be converted to oral delivery. TPE® technology is potentially well suited for drugs with chronic indications, where frequent dosing is required and the need for an oral alternative is greatest. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary.
Additional information can be found at www.ChiasmaPharma.com.
Forward-Looking Statements:
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical and commercial potential of Mycapssa™ and Chiasma’s TPE® technology, and statements regarding the FDA’s review of Chiasma’s NDA for Mycapssa™ and a potential commercial launch of this product candidate. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the regulatory review process generally; the risk that the FDA may not make a decision on Chiasma’s NDA by the PDUFA target date; the risk that the FDA may determine that that the data included in the NDA are insufficient for approval and that we must conduct additional clinical trials, or nonclinical or other studies before oral octreotide can be approved; the risk that the results of previously conducted studies involving oral octreotide or other product candidates will not be repeated or observed in ongoing or future studies or following commercial launch, if such product candidates are approved; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Chiasma’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk that oral octreotide, if approved, will not be successfully commercialized; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Chiasma’s ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Chiasma’s dependence on third parties, including with respect to the manufacture of commercial supply in anticipation of commercial launch, if oral octreotide is approved. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the final prospectus related to Chiasma’s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as discussions of potential risks, uncertainties and other important factors in Chiasma’s subsequent filings with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q filed on November 16, 2015. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.
CONTACT: Media: Cammy Duong MacDougall Biomedical Communications (781) 591-3443 cduong@macbiocom.com Investors: Jason Fredette Chiasma, Inc. (617) 928-5306 Jason.Fredette@ChiasmaPharma.com
