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news.Genzyme, a biotechnology company, and Osiris Therapeutics, a stem cell therapeutic company, have entered a strategic alliance for the development and commercialization of Prochymal and Chondrogen, two novel, late-stage adult stem cell treatments that hold significant potential to treat a wide range of diseases.
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Under the terms of the agreement, Osiris will commercialize Prochymal and Chondrogen in the US and Canada, and Genzyme will commercialize the treatments in all other countries. Genzyme will make an up-front payment of $130 million to Osiris, plus potential significant milestone and royalty payments.
Prochymal is currently being evaluated in two Phase III trials for graft versus host disease and one Phase III trial for Crohn’s disease; data from all three trials are expected in 2009. It is also being studied in Phase II trials for type 1 diabetes and chronic obstructive pulmonary disease. A Phase II trial of Prochymal for acute myocardial infarction and a Phase II/III trial of Chondrogen for osteoarthritis of the knee are expected to begin soon.
Osiris is responsible for the clinical development costs for all ongoing trials, as well as future trials for additional indications through completion of Phase II development. Osiris and Genzyme will share the cost of future Phase III and IV clinical trials, with a 60% Osiris/40% Genzyme split.
The collaboration will leverage Osiris’s leadership position developing novel stem cell therapies, and Genzyme’s regulatory and marketing infrastructure outside of the US, as well as its expertise commercializing cell therapies.
Pursuant to the terms of the agreement, Osiris also has the potential to receive a total of up to $1.25 billion in milestone payments from Genzyme. Osiris is eligible to receive up to $500 million in development and regulatory milestone payments for Prochymal related to graft versus host disease, Crohn’s disease, and other potential additional indications that the companies develop together.