EAST WINDSOR, N.J. and GLEN ALLEN, Va., July 31 /PRNewswire-FirstCall/ -- 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(TM) (mecasermin rinfabate [rDNA origin] injection) as it expands with the development of IPLEX(TM) in broader therapeutic indications. IPLEX(TM) 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(TM) 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(TM) needed to meet the long-term demand for the product.
About Phyton Biotech, Inc.
Phyton Biotech, Inc., based in East Windsor, N.J., is a subsidiary of DFB Pharmaceuticals, Inc. Phyton's proprietary plant cell culture technology platform is used to develop and manufacture products with applications in the pharmaceutical and biotech industries. Phyton is focusing its research and development efforts on developing transgenic protein therapeutics utilizing Phyton's broad expertise in plant cell suspension culture technology. Other current Phyton projects include production of paclitaxel for Bristol-Myers Squibb's TAXOL(R) oncology product and development of DiAthegen LLC's protein therapeutics focused in the endocrine and oncology areas. Phyton is on the web at http://www.phytonbiotech.com .
Based in Fort Worth, DFB Pharmaceuticals, Inc. is a privately held Texas corporation that provides technology-driven pharmaceutical products, outsourcing services, and licensing opportunities to the healthcare industry worldwide through Phyton and its other affiliates, HEALTHPOINT, Ltd. and Coria Laboratories, Ltd., both branded marketing organizations; DPT Laboratories, Ltd., an outsourcing service organization to the pharmaceutical industry; and DFB Bioscience, focusing on cell based therapeutic research and development. Visit http://www.dfb.com for additional information.
About Insmed Incorporated
Insmed, Inc., based in Glen Allen, Virginia, is a biopharmaceutical company focused on the development and commercialization of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit http://www.insmed.com . The company's leading product, IPLEX was approved as an orphan drug by the United States Food and Drug Administration in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP- 3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I replacement therapy. It is also the only FDA-approved therapy that provides both rhIGF-I and rhIGFBP-3 to treat children with severe primary IGFD. The drug, which was launched in May 2006, is also being investigated for various other indications with unmet medical needs, including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS).
Phyton Biotech, Inc.; Insmed Incorporated