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Keele, UK, and Malvern, Pennsylvania, USA, 3 August 2005 – Cobra Biomanufacturing Plc (AIM: CBF) and Auxilium Pharmaceuticals, Inc. (NASDAQ, AUXL) jointly announce their agreement for the production and supply of the protein biopharmaceutical AA4500. Under the agreement, Cobra will provide scale up and cGMP manufacturing services and supply of drug for Phase II/III clinical trials. AA4500 is being developed by Auxilium as a potential treatment of Peyronie’s and Dupuytren’s Disease and has been granted orphan drug status by the FDA.
Currently, there are no approved treatments for
these conditions. The value of the agreement is in excess of $3.3 million for
process development and clinical lot production through 2006.
David Thatcher, Chief Executive of Cobra
Biomanufacturing commented:
“This agreement cements a strong and productive relationship with Auxilium and gives Cobra the opportunity to deploy its skills in biologics process development and production of this potentially exciting and innovative product candidate. This contract is a milestone in Cobra’s development and represents a major step forward and opportunity in maximizing value from Cobra’s expertise in manufacture of protein biopharmaceuticals.”
Ms. Gerri Henwood, Chief Executive of
Auxilium Pharmaceuticals Inc commented:
“We have been impressed with Cobra’s expertise and track record in protein process development and their ability to take on the challenging scale up and development of novel protein products. We feel confident that Cobra will deliver us quality AA4500 for our Phase II/ III clinical trials. We believe their capabilities and experience make Cobra a great fit with our manufacturing requirements.”
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About Auxilium Pharmaceuticals
Auxilium Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on urology and sexual health. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its sales and marketing team of more than 110 people. The company is developing a product in Phase II for treatment of Peyronie’s Disease and Dupuytren’s Disease, products for androgen replacement, overactive bladder and pain using our licensed transmucosal film delivery system, as well as other products for urologic and sexual health. For additional information, visit http://www.auxilium.com.
About Cobra Biomanufacturing Plc
Cobra Biomanufacturing Plc is a leading international manufacturer of biopharmaceuticals to the lifescience industry. Founded in 1992, Cobra provides innovative manufacturing solutions to the biopharmaceutical industry covering DNA, virus, cellular therapeutics and recombinant protein products. www.cobrabio.com
For further information:
Cobra Biomanufacturing Plc Tel: 44 (0) 1782 714 181 David Thatcher, Chief Executive Auxilium Pharmaceuticals, Inc Tel: + 1 484 321 5902 James E Fickenscher – CFO Buchanan Communications Tel: 44 (0) 207 466 5000 Tim Anderson/Mark Court/Rebecca Dietrich Lazar Partners Tel: + 1 212 867 1762 Felica Vonella
Northbank Communications
Marc Egelhofer Tel: 44 (0) 1260 296 500 |
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