Phyton Biotech Signs Development Agreement With Insmed
East Windsor, NJ and Glen Allen, VA - Phyton Biotech, Inc., a DFB Pharmaceuticals affiliate, and Insmed Incorporated have announced an agreement whereby Phyton will utilize its cGMP plant cell fermentation technology to develop a manufacturing process that could be utilized to meet the future demand of IPLEX (mecasermin rinfabate [rDNA origin] injection) as it expands with the development of IPLEX in broader therapeutic indications. IPLEX was approved by the FDA in December 2005 for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
One of the key attributes of Phyton's cGMP plant cell fermentation technology is that it can be scaled up to any size needed. Phyton's German subsidiary, Phyton Biotech GmbH, operates the world's largest commercial cGMP manufacturing facility for plant cell fermentation, with bioreactors up to 75,000 liters in size.
"The efficiencies and economies of scale assured by our plant cell fermentation system provide an excellent solution to meet the future demand for IPLEX as its use expands into broader therapeutic indications," said Magnus Precht, President of New Jersey-based Phyton Biotech.
"We recognize the potential of Phyton Biotech's technology to help Insmed address the anticipated future demand for our product," said Insmed CEO Geoffrey Allan, Ph.D. "If this cutting edge technology proves successful with our product, we believe it will give Insmed a long-term competitive advantage over companies utilizing older technologies."
"Our ability to genetically manipulate plant cells and to scale production combine to offer an advantage in the marketplace," said Mr. Precht, "The Phyton plant cell fermentation technology has utility not found in other cell expression systems."
"This agreement is an important step toward DFB's and Phyton's strategic goals of developing and manufacturing novel pharmaceutical products," said H. Paul Dorman, CEO and Chairman of DFB Pharmaceuticals.
The companies expect that the development conducted under the agreement will demonstrate the efficiencies of Phyton's unique plant cell expression technology and its ability to produce the quantities of IPLEX needed to meet the long-term demand for the product.
SOURCE: Phyton Biotech, Inc. and Insmed Incorporated