NEWTON, Mass. and JERUSALEM, Israel, Aug. 24, 2015 /PRNewswire/ -- Chiasma, Inc. (NASDAQ: CHMA), a U.S. late-stage biopharmaceutical company developing Mycapssa™ (octreotide capsules) for the maintenance therapy of adult patients with acromegaly, today announced the appointment of William H. Ludlam, M.D., Ph.D., as vice president of medical affairs, effective August 26, 2015.
Dr. Ludlam, a highly-regarded academic leader in the pituitary and rare disease space, comes to Chiasma after spending the last four years at Novartis Pharmaceuticals, where he served most recently as Senior Medical Director for the U.S. Clinical Development and Medical Affairs (USCDMA), Pituitary Disorders, Rare Diseases Franchise. Novartis is currently a leading seller of injectable octreotide, one of the standard treatment options for patients suffering from acromegaly.
In his role at Chiasma, Dr. Ludlam will be responsible for developing strategy around clinical and technical information to support the planned commercial launch of Mycapssa™ for the maintenance treatment of adults with acromegaly. He will also lead all medical review activities around the Company's product education campaign, including its presence at key scientific events. In August 2015, the U.S. Food and Drug Administration (FDA) accepted for filing Chiasma's New Drug Application (NDA) for the marketing and sale of Mycapssa™ in acromegaly. The FDA also conditionally accepted the Company's proposed trade name of Mycapssa™, a decision that is expected to be finalized upon potential approval of the NDA.
"Dr. Ludlam's extensive academic and industry experience in the rare disease space, particularly pituitary disorders, makes him an ideal choice to help lead the medical strategy for our anticipated launch of Mycapssa™ in 2016," said Mark Leuchtenberger, chief executive officer of Chiasma. "Dr. Ludlam has worked firsthand with acromegaly patients, both in his current role at Novartis and his previous clinical positions, many of whom are treated with injectable octreotide. His relationships with both the academic and medical communities will significantly enhance our ability to bring octreotide capsules to patients still suffering from severe unmet needs."
Prior to joining Novartis in 2012, Dr. Ludlam spent 15 years in a number of academic and clinical roles. From 2007 to 2011, he served as medical director at the Seattle Pituitary Center within the Neuroscience Institute at the Swedish Medical Center, and from 2002 to 2006 as medical director of the Pituitary Unit at the Oregon Health and Science University. Dr. Ludlam helped develop both treatment centers and conducted clinical research for novel treatment options for pituitary disorders while actively treating patients with acromegaly and Cushing's disease, among other conditions.
Dr. Ludlam holds an M.D. and Ph.D. from the Albert Einstein College of Medicine, and completed his Internal Medicine residency and Endocrinology fellowship at the Oregon Health & Sciences University, where he also conducted research at the Vollum Institute under Dr. Richard H. Goodman.
"I am extremely pleased to be joining Chiasma prior to the potential launch of Mycapssa™," said Dr. Ludlam. "With my personal experience around acromegaly, both in a clinical and commercial setting, I am well aware of the limitations with current injectable options. Mycapssa™ offers the potential to change the treatment paradigm of this burdensome disease, and I am eager to work with our accomplished team to help bring this much-needed option to patients and doctors."
About MYCAPSSA™ (octreotide capsules)
MYCAPSSA™ (octreotide capsules) is an oral drug proposed for the maintenance therapy of adult patients with acromegaly. If approved, octreotide capsules would be the first oral somatostatin analog approved for acromegaly. Chiasma filed on June 15, 2015 a New Drug Application (NDA) for this product candidate. The FDA has accepted the NDA for filing and is expected to inform Chiasma of the Prescription Drug User Fee Act (PDUFA) date by the end of August. The PDUFA date is the target date for the FDA to complete its review of the NDA. Octreotide capsules have been granted orphan designation in the United States and the European Union for the treatment of acromegaly.
Octreotide capsules is an investigational drug that has not been approved for use in any jurisdiction. The trade name MYCAPSSA™ has been conditionally accepted by the FDA as the proprietary name for the octreotide capsules product candidate.
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) for the orphan condition acromegaly. 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 using the Company's Transient Permeability Enhancer (TPE®) technology. 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 oral octreotide and Chiasma's TPE® technology, and statements regarding the timing of the FDA's review of Chiasma's NDA for oral octreotide 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 determine that the data included in the NDA are insufficient for approval and that Chiasma 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 others 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 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. 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.
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SOURCE Chiasma, Inc.