SOMERSET, NJ, and SAN DIEGO, CA – April 16, 2012 — Nascent Biologics, Inc. and Catalent Pharma Solutions today announced the signing of a product development agreement. Under the terms of the agreement, Catalent will engineer a cell line expressing Nascent’s proprietary “Pritumumab” antibody using Catalent’s GPExÒ technology, and will subsequently produce purified monoclonal antibody to support Nascent’s Phase I/II human clinical trials with Pritumumab for treatment of an unmet clinical need—treatment of brain cancers, such as astrocytomas and glioblastomas. GPExÒ technology is used to generate mammalian cells with high yields and stability, which will help speed the drug to clinic.
Mark Glassy, Ph.D., CEO of Nascent, observed, “We are committed to bring this potential new treatment to patients afflicted with this terrible disease. Our first clinical data are very encouraging and we look forward to working with Catalent to gather the key clinical data that will enable further development to be “fast tracked” with relevant regulatory agencies on a worldwide basis. Nascent Biologics is in the process of forming a commercial partnership for further clinical development, registration, and marketing of its Pritumumab product.”
“We are delighted to be part of a program that will not only validate our GPEx technology as a leading system for the manufacture of biologic products, but will also aid in significantly improving the treatment outcomes for such a serious and untreatable disease,” said Kent Payne, Vice President and General Manager of Catalent’s Biologics business.
Glioblastoma, a form of brain cancer from which Senator Edward Kennedy recently succumbed, afflicts 10,000 Americans each year, with a one-year survival rate of 50% and a five-year survival rate of just 3%. There is currently no effective treatment for this disease. In previous clinical trials with Pritumumab, five-year survival rates of brain cancer patients were about 9-fold higher, at 27%. Nascent wishes to confirm and validate the earlier clinical trial data and move forward into Phase III and subsequent registration of the product.
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 9,400 people at 29 facilities worldwide and in fiscal year 2011 generated more than $1.6 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.
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Nascent Biologics is an early-stage biopharmaceutical company that is developing two proprietary platform technologies, MultiPharmTM and UberkineTM, under the clinical premise that the most effective way to treat disease is to modulate (boost or suppress) the human body’s natural ability to generate an immune response. Pritumumab is the first in a series of treatments for a variety of cancers and auto-immune diseases.