Genzyme (GENZ) announced that they have entered a strategic alliance for the development and commercialization of Prochymal and Chondrogen, two novel, late-stage adult mesenchymal stem cell treatments that hold significant potential to treat a wide range of diseases. These stem-cell products are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.
Prochymal is currently being evaluated in two phase 3 trials for graft vs. host disease ((GvHD)) and one phase 3 trial for Crohn’s disease; data from all three trials are expected in 2009. It is also being studied in phase 2 trials for type 1 diabetes and chronic obstructive pulmonary disease. A phase 2 trial of Prochymal for acute myocardial infarction and a phase 2/3 trial of Chondrogen for osteoarthritis of the knee are expected to begin soon.
Prochymal has been granted Fast Track status by the FDA for GvHD and Crohn’s disease, and is the first stem cell product to receive FDA expanded access approval, making the product available now to children with life-threatening GvHD. It has also been granted Orphan Drug designation by the FDA and EMEA for GvHD. U.S. regulatory approval in this indication is anticipated as early as the end of next year; E.U. approval is expected in 2010.
I think this is a pretty good (albeit pretty rich) deal all around. Genzyme gains a potentially first-in-class therapeutic modality highly touted as the potential, “future of medicine”, while Osiris gains a hefty chunk of cash and the Genzyme’s competence in marketing and delivering complex products. This fact can’t be overlooked; the best deal isn’t always the one with the highest upfront or larger royalty back end, rather, codevelopment / copromotion deals like this often require things that can’t be placed on a balance sheet in order to be successful: cooperation and expertise.
Starting with the signing of the Isis deal for mipomersen, it is clear to me that Genzyme understands these qualitative aspects of the alliance process and is offering more than just cash and this, in my opinion, has probably given them the edge (in the eyes of out-licensing biotechs) over companies with larger pocketbooks.