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Chondrogen addresses post-surgery indication, NOT specifically OA treatment

November 30, 2007

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

Stem cells plus HA provide a physiologically relevant combination that has real potential in tissue repair and regenerative medicine. But the press release goes further than warranted, in implying that Chondrogen addresses the OA market as a whole. The trial specifically evaluated the effects of the product after meniscus surgery (likely partial menisectomy, but not specified clearly). The post-surgery market is important in itself, and the trial identifies a potentially fruitful new approach to musculoskeletal repair that has practical advantages and which could be integrated into current practice patterns without major disruption. .

Injection regimen for IAHA products

November 16, 2007

Analysis of:Genzyme Receives FDA Response Letter on Synvisc-One (TM) | www.pipelinereview.com

TRIAL RESULTS: FDA's decision not to approve Synvisc-One at this time should be evaluated based on the two publicly disclosed RCTs that evaluated Synvisc-One. (not just the data presented in Barcelona) TREATMENT REGIMEN: The proposed Synvisc-One treatment regimen must be understood in terms of current IAHA labeling with respect to flexible treatment regimens. REIMBURSEMENT: Payer acceptance of "improved" IAHA products that will be more expensive per syringe should not be taken as a given. MARKET ELASTICITY: The availability of an IAHA product that can be used as a single injection treatment regimen will significantly change the market outlook for IAHA.

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