PRINCETON, NJ – September 21, 2005 – Laureate Pharma, Inc. and Enobia Pharma, Inc. announced today that they have entered into a biopharmaceutical development and manufacturing agreement for process development and manufacture of cGMP batches of Enobia’s recombinant enzyme sPHEX Metallo Peptidase. The project is well underway and Laureate Pharma expects to supply Enobia with material for their Phase I clinical trials 3Q 2006. Terms of the agreement were not disclosed.
sPHEX is an enzyme replacement therapy for the treatment of X-linked Hypophosphatemia (XLH), the most prevalent form of inherited rickets affecting around 40,000 people. The main objective of Enobia’s enzyme replacement therapy for XLH is to replace the defective PHEX enzyme with a functional enzyme obtained through recombinant DNA technology.
Robert J. Broeze, Ph.D., President & CEO of Laureate Pharma, said, “Enobia has the potential to become a major leader in the field of enzyme replacement therapy for bone diseases and Laureate Pharma looks forward to a productive and successful relationship with them to provide clinical supply of their recombinant enzyme. We are very pleased to be working with Enobia on this exciting product.”
“As sPHEX has shown promising preclinical results, our partnership with Laureate Pharma is a crucial step in our manufacturing strategy. We look forward to working with Laureate and advancing our clinical program,” said Benoit Huet, President and CEO at Enobia.
About Laureate Pharma
Laureate Pharma is a full service CMO with headquarters in Princeton, NJ. The company is dedicated to supporting the development and commercialization of pharmaceutical products for pharmaceutical and biopharmaceutical companies. Laureate Pharma’s biopharmaceutical division, located in Princeton, NJ, provides a wide range of product development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding testing, validation, analytical services and regulatory support. This division is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products. Mammalian cells are grown in stirred-tank or hollow-fiber bioreactors for production of biopharmaceutical proteins, which are purified by state-of-the-art semi-automated chromatography systems. Laureate Pharma’s microparticle technologies division, located in Totowa, NJ, supplies extended release development, formulation and filling services through commercial scale at its cGMP manufacturing facility. Laureate is a wholly owned subsidiary of Safeguard Scientifics (NYSE: SFE). For more information on Laureate Pharma, please contact Michael Cavanaugh, Vice President Sales, Marketing, and Business Development at 1.608.916.3570, by email at [email protected] or visit www.laureatepharma.com.
About Enobia Pharma, Inc.
Enobia Pharma is a privately held Canadian biotech company founded in 1997. The Company is engaged primarily in developing solutions for enzyme-replacement therapy and the treatment of bone diseases. The head office of Enobia is located at 2901 Rachel Street East, Suite 23, in Montreal, Quebec, CANADA. For more information on the company please contact Mr. Benoit Huet at 514-596-2901 or visit its website at www.enobia.com