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09:15 AM Eastern Standard Time, 11/20/2009 (MidnightTrader) — Dow Jones U.S. Health Care Index: -1.94 (-0.63%) at 308.20 (Thursday regular session close)
Top Health Care Stocks:
JNJ: -1.01%
PFE: flat
ABT: flat
MRK: -0.51%
AMGN: flat
Health care shares are flat to lower in the pre-market session. Merck (MRK) is down fractionally after announcing the Committee for Medicinal Products for Human Use has recommended approval of Elonva (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology program. Antigenics (AGEN) is lower after announcing the Committee for Medicinal Products for Human Use adopted a negative opinion on the marketing authorization application for Oncophage (vitespen) as a treatment in earlier-stage localized renal cell carcinoma (kidney cancer). Novavax (NVAX) declines on a plan to sell shares.
Merck said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Elonva (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology program. If approved by the European Commission, Merck would receive marketing authorization for Elonva with unified labeling valid in all European Union member states. Elonva is the first in the class of sustained follicle stimulants. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily recombinant follicle stimulating hormone preparation in a COS treatment cycle, the company said.
Meanwhile, Antigenics announced that CHMP has formally adopted a negative opinion on the marketing authorization application for Oncophage (vitespen) as a treatment in earlier-stage localized renal cell carcinoma (kidney cancer). A negative vote of the CHMP indicating this opinion was verbally conveyed to Antigenics and announced in a press release issued on October 21, 2009. Based on this opinion, Antigenics has decided to withdraw its marketing authorization application and to evaluate its options going forward, including a potential re-filing at a later date. A decision to re-file would be dependent on outcomes following meetings with health authorities in individual European countries and with the EMEA, as well as based on further accumulation and review of clinical data.
Novavax will sell a certain volume of shares, declining to state the exact number.