Tuesday, December 7, 2010

Seattle Genetics' (NASDAQ:SGEN) Vedotin Risk Appears to Shrink

Risk related to Seattle Genetics' (NASDAQ:SGEN) b. Vedotin seem to have lowered after reports on the ORR for its trial were released.

Needham said, "The data from the pivotal trial of b. vedotin in r/r HL were featured in an ASH Meeting press release over the weekend and highlighted at a company meeting in Orlando. Previously, the Company had reported the ORR for its pivotal trial of b. vedotin in HL was 75% by independent central review. New information from this trial of 102 patients reported at the ASH Meeting included: (1) 34% complete response rate; (2) overall median duration of response 29 weeks by investigator review, and median duration of response not met for CRs at > 1 year of follow-up; (3) 94% of patients with tumor reductions; and (4) a dropout rate of 20% due to adverse side effects. Furthermore, a preview of the ALCL pivotal data expected Tuesday showed an ORR of 87% (57% CR) by independent review. Based on these data, Seattle Genetics announced plan to submit a BLA for b. vedotin for both r/r HL and r/r ALCL in 1Q11, following recent FDA discussions, with plans to submit a MAA in 1H11 by partner Millennium/Takeda...We remain highly impressed by the ORR rate, CR rate, and durable responses in these hard-to-treat patient populations: the quality of the data decrease the development and commercialization risk going forward."

Needham maintains their "Buy" rating on Seattle Genetics, which closed Monday at $15.23, dropping $0.64, or 4.03 percent. Needham has a price target of $18 on the company.

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