Catalent Announces Partnership with Nuron Biotech to Provide Sterile Delivery and Supply of MS Treatment in Phase III Clinical Study
SOMERSET, NJ, January 31, 2011 — Catalent Pharma Solutions, a leading provider of drug and biologic development services, delivery technologies and supply solutions, announced that it has entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS).
Under the terms of the agreement, NU100 will be produced at Catalent’s facility in Brussels, Belgium, where this injectable product will be formulated, filled and packaged in a prefilled syringe. Nuron Biotech is currently planning to take NU100 into Phase III clinical trials in 2011.
“For decades, Catalent’s sterile technology business has a proven track record of partnering with innovators like Nuron Biotech to efficiently take products to market faster. We are excited to have the opportunity to apply our sterile delivery expertise to support Nuron through this complex and important stage of product development,” said Sheila Dell, Ph.D., Vice President Business Development, Catalent. “In addition to preparing and supplying NU100 for Phase III clinical trials, we are pleased to be able to support commercial manufacturing during the product’s first three years on the market.”
“Our senior managers have come to know and trust the Catalent team during previous business relationships, and we are pleased to re-establish this mutually beneficial partnership,” commented Shankar Musunuri, PhD, MBA, Chief Executive Officer, Founder, Nuron Biotech. “We have strong confidence in Catalent’s ability to support Nuron with NU100 and with other future scale-up and launch opportunities.”
More than 2.1 million people worldwide are thought to be affected by MS, an inflammatory disease of the central nervous system that is often debilitating. Nuron believes that NU100 will be differentiated from other interferon-beta products by virtue of a certain, patent protected manufacturing technology that Nuron utilizes, that creates a novel interferon beta-1b product that is free of human serum albumin (HSA) and is essentially free of aggregates.
Catalent’s Sterile Technologies business provides development, clinical and commercial manufacturing services for sterile injectables and sterile Blow-Fill-Seal products. Catalent’s manufacturing capabilities in this complex arena incorporate an extensive range of sterile injectable offerings, including filling drugs or biologics into vials, pre-filled syringes, bags and other stable delivery formats.
Nuron Biotech is focused on innovative and improved specialty biologics and vaccines. Nuron’s vision is to bring biologics to market with enhanced product profiles to provide better health for patients. Nuron’s Founders and Management team members are veteran biotech executives who have made significant contributions at Pfizer and other biotechnology companies prior to their arrival at Nuron.
Nuron is currently working on products in three disease areas; Central Nervous Systems (CNS), Wound Healing and Vaccines.
Nuron is currently in discussions with other biotechnology companies to expand their portfolio in the areas of specialty biotech and vaccines. www.nuronbiotech.com
From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. Catalent employs approximately 9,000 people at 28 facilities worldwide and in fiscal year 2010 generated more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, NJ.