Lonza Group Ltd, a market leading custom manufacturer of advanced intermediates and active pharmaceutical ingredients (APIs) for the pharmaceutical market, and Alnara Pharmaceuticals, Inc. a pharmaceutical company developing novel, non-systemic orally delivered protein therapeutics for the treatment of metabolic diseases, jointly announce an agreement to enter into an alliance to manufacture Alnara’s lead product liprotamase. Liprotamase is a novel, oral, pancreatic enzyme replacement therapy (PERT) for patients with pancreatic insufficiency. The agreement will support Alnara’s New Drug Application (NDA) filing for liprotamase and the production of launch quantities of the product.
Under the scope of this manufacturing agreement, Lonza will provide microbial fermentation, process optimization, technical and regulatory support. All related production will be conducted in Lonza’s FDA registered facility in Kouřím, Czech Republic.
“We are happy to enter into this agreement with Alnara. This collaboration continues our efforts to produce liprotamase. Working together with Alnara we have reached an important milestone in the launch of liprotamase”, commented Uwe H. Böhlke, Ph.D., COO Lonza Custom Manufacturing, Exclusive Synthesis.
Alexey Margolin, Ph.D., President & Chief Executive Officer of Alnara Pharmaceuticals added: “Lonza is the premier company in the manufacture of custom protein therapeutics and the ideal partner to manufacture liprotamase since consistent batch-to-batch production is a benefit of the microbial source and Alnara’s proprietary technology. Now that we have completed the liprotamase clinical development program, this agreement supports our commericlaization efforts as we prepare to submit an NDA and bring this product directly to pancreatic insufficiency patients living with Cystic Fibrosis (CF) and other diseases. We believe liprotamase will offer tremendous advantages to physicians and patients, and has the potential to be the first significant advance to treat pancreatic insufficiency in 30 years. ”
Liprotamase is a novel, oral, non-porcine PERT designed to treat maldigestion, malabsorption and malnutrition as a result of exocrine pancreatic insufficiency associated with CF, chronic pancreatitis (CP), pancreatic cancer, pancreatectomy and other pancreatic conditions. Results from an international, Phase 3 open-label, long-term safety study demonstrating the safety and nutritional benefits of liprotamase, were recently presented at the 23rd Annual North American Cystic Fibrosis Conference. 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. Approximately 90 percent of CF patients receive PERT to improve nutritional status and bowel-related symptoms related to pancreatic insufficiency. Overall health in people living with pancreatic insufficiency is directly related to their nutritional status and survival.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.
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 Frazier Healthcare Ventures, Third Rock Ventures and Bessemer Venture Partners. For more information, please visit the company’s website at www.alnara.com.
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