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news.Cobra Biomanufacturing and Auxilium Pharmaceuticals have extended their agreement on the manufacturing and development of AA4500, a potential treatment of Peyronie's disease and Dupuytren's disease that has been granted orphan drug status by the FDA.
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AA4500 is being developed by Auxilium, whilst Cobra will continue to provide manufacturing services and supply the drug for phase II/III clinical trials.
“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,” commented Gerri Henwood, chief executive of Auxilium Pharmaceuticals. “We feel confident that Cobra will deliver us quality AA4500 for our phase II/ III clinical trials.”
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.