NEWTON, Mass. and JERUSALEM, Israel, Aug. 10, 2015 /PRNewswire/ -- Chiasma, Inc., a U.S. late-stage biopharmaceutical company developing octreotide capsules for the orphan condition acromegaly, today announced the appointment of Anand Varadan as chief commercial officer, effective August 17, 2015.
Mr. Varadan brings more than 20 years of commercial experience to Chiasma and will assume responsibility for all commercial activities in the U.S. and Europe around the Company's planned launch of its investigational oral octreotide capsules for the maintenance treatment of adults with acromegaly. In June 2015, Chiasma submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for octreotide capsules for this indication.
"Anand's extensive global commercialization experience in different markets and regulatory environments makes him ideally suited to lead our commercial team during this crucial period as we near a potential approval decision for our lead oral octreotide capsules candidate in the United States," said Mark Leuchtenberger, chief executive officer of Chiasma. "In his previous roles, Anand has developed world-class commercialization plans in therapeutic areas ranging from inflammation and nephrology to cardiovascular and metabolic disease, and he brings an understanding of the North American and European landscapes that will be invaluable for guiding our first product to market."
Mr. Varadan joins Chiasma from Amgen, where he most recently served as Vice President of Marketing for the U.S. Inflammation and Nephrology Business Unit. During his tenure at Amgen, Mr. Varadan led direct consumer and physician U.S. marketing efforts for brands including Enbrel® for rheumatoid arthritis and psoriasis, Sensipar® for hyperparathyroidism, and the Epogen®/Aranesp® franchise for anemia. He also led the launch of Mimpara® (Sensipar® in the U.S.) for kidney disease across the United Kingdom and Ireland. In addition, Mr. Varadan has worked on commercialization strategy in the areas of cardiovascular disease, metabolic disease and neuroscience.
Prior to Amgen, Mr. Varadan held brand manager positions at Procter and Gamble Company, where he led the U.S. pre-launch for Actonel® for osteoporosis and the brand team for Asacol® for ulcerative colitis. Mr. Varadan holds an M.B.A. from the University of Rochester and a B.A. in Zoology from George Washington University.
"I am very excited to be joining the Chiasma team at this crucial juncture, and look forward to helping to unlock the value that oral octreotide capsules can potentially bring to acromegaly patients currently suffering from unmet needs related to the limitations of existing treatments," said Mr. Varadan. "The recent NDA submission for octreotide capsules and the broad potential for Chiasma's TPE® technology in other rare disease areas makes this an opportune time to join the Company, and I look forward to working with the executive team to achieve our vision of developing and commercializing oral medications in indications that are currently only treatable by injection."
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 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 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 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 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 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.