Healthcare Industry News: enzyme replacement therapy
News Release - January 28, 2010
Alnara Pharmaceuticals Secures $35 Million in Series B RoundProceeds Will Further Advance Liprotamase Commercialization Efforts
CAMBRIDGE, Mass.--(HSMN NewsFeed)--Alnara Pharmaceuticals, Inc., a pharmaceutical company developing non-systemic, orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that it has secured $35 million in Series B venture capital financing. The round was led by new investor MPM Capital, joined by current investors Third Rock Ventures, Frazier Healthcare and Bessemer Venture Partners. In conjunction with the MPM investment, managing director Ashley Dombkowski, Ph.D., will join Alnara’s board of directors.
“We are delighted to welcome both MPM as an investor and Ashley as a board member and we are grateful for the continued support from our existing investors,” stated Alexey Margolin, Ph.D., chief executive officer of Alnara. “This financing serves as an important external validation of the significant market opportunity for liprotamase and our pre-clinical platform, and provides us with the resources to expand our commercialization efforts in the rapidly growing pancreatic enzyme replacement therapy (PERT) market. This is going to be a very exciting year for Alnara, and we remain on track to file a new drug application (NDA) for liprotamase with the U.S. Food and Drug Administration in the first quarter of this year.”
“I am honored to join the Alnara board,” stated Dr. Dombkowski. “This round of funding increases financial flexibility for Alnara as the company prepares to commercialize liprotamase. As a recombinant product with positive long-term safety and nutritionally relevant data, liprotamase helps to address many of the unmet needs in this dynamic therapeutic area. This strong product profile, combined with the NDA filing planned for this quarter, positions Alnara on the cusp of significant value creation opportunities.”
Rich Aldrich, chairman of the board of Alnara commented, “We believe the regulatory approval and launch of liprotamase as a non-porcine PERT will represent a new paradigm in the treatment of pancreatic insufficiency. Over the last year, Alnara has transformed from a start-up company to a leader in protein therapeutics preparing to commercialize a potentially breakthrough product in liprotamase. Alexey and his team have done a phenomenal job advancing the development program for liprotamase and continuing the collaboration with the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) as we prepare to bring this much needed new therapy to patients.”
Proceeds from the financing will be used to continue to advance the regulatory filings, commercial planning and launch preparation efforts in support of liprotamase for the treatment of exocrine pancreatic insufficiency and to advance the company’s pre-clinical platform. The company also plans to use proceeds to finalize development of a novel pediatric formulation which meets a significant unmet need in patients with cystic fibrosis (CF). Overall health in people living with pancreatic insufficiency is directly related to their nutritional status and survival.
About Liprotamase & Pancreatic enzyme replacement therapy (PERT)
Liprotamase is a novel, oral, non-porcine pancreatic enzyme replacement therapy designed to treat maldigestion, malabsorption and malnutrition as a result of exocrine pancreatic insufficiency associated with cystic fibrosis chronic pancreatitis, pancreatic cancer, pancreatectomy and other pancreatic diseases. Patients with pancreatic insufficiency cannot properly digest and absorb fat, protein, and carbohydrates preventing adequate nutrient absorption. PERT is a life-saving treatment involving the administration of pancreatic enzymes. Alnara believes liprotamase may have the potential to overcome the challenges and issues associated with currently available therapies, by reducing pill burden, providing a formulation for patients unable to swallow capsules and removing the risk for viral contamination thereby providing a first-in-class non-porcine produced PERT. Cystic fibrosis is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States and nearly 100,000 people worldwide.
Results from an international, Phase 3 open-label, long-term safety study presented at the North American Cystic Fibrosis Conference in October demonstrated the safety and nutritional benefits of liprotamase. The nutritional parameters measured during the study showed nutritional maintenance relative to the U.S. population, which is a major finding for this historically challenged patient group, as well as a significantly reduced pill burden. Approximately 90 percent of CF patients receive PERT to improve nutritional status and bowel-related symptoms related to pancreatic insufficiency. Alnara expects to file a new drug application for liprotamase with the U.S. Food and Drug Administration in the first quarter of 2010.
About MPM Capital
MPM Capital is one of the world's largest life science-dedicated venture investors. With committed capital under management of $2.3 billion, MPM Capital is uniquely structured to invest globally in healthcare innovation.
Alnara Pharmaceuticals, Inc. is dedicated to developing and commercializing novel protein therapeutics for the treatment of metabolic diseases. The company's innovative approach focuses on designing effective protein therapies that can be orally delivered directly to the gastrointestinal tract without being absorbed into the bloodstream. Alnara’s lead product is liprotamase, a novel, non-porcine pancreatic enzyme replacement therapy, which has completed Phase 3 clinical development in collaboration with the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT). The company is committed to bringing breakthrough new treatments to patients with unmet medical needs. Based in Cambridge, Massachusetts, Alnara is backed by an experienced management team and top-tier venture investors, including Third Rock Ventures, Frazier Healthcare, MPM Capital and Bessemer Venture Partners. For more information, please visit the company’s website at www.alnara.com.
Source: Alnara Pharmaceuticals
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