Tuesday, June 12, 2012

Biotech Stock Alert – European Regulators slap Amgen with Negative Opinion

Amgen Inc. (NASDAQ: AMGN) shares slipped into the red this morning after the company announced it received word� that� the Committee for Medical Prodcuts for Hum Use�s (CHMP) of the European Medicines Agency (EMA) gave a negative opinion on Vectibix� use with chemotherapy in metastatic colorectal cancer.

The CHMP declined to recommend the company�s application to extend the marketing authorization for Vectibix in Europe to include in combination with chemotherapy for treatment of patients with wild-type KRAS metastatic colorectal cancer.

Amgen said that it will review the opinion from CHMP and look at the appropriate next steps and that the company continues to believe that Vectibix, which has been approved and established in more than 30 countries outside of the U.S. in combination with chemotherapy, offers an important treatment option for patients with wild-type KRAS mCRC.

Earlier this month, Amgen completed the acquisition of BioVex Group Inc. BioVex is a Massachusetts-based biotechnology company with additional operations in Abingdon, UK.

Amgen shares have a 52-week range of $50.26-$61.26. Year-to-date the stock fell 2.76%. In the last one year the stock fell 8.45%. It is currently trading below its 50-day and 200-day moving averages.

In today�s trading Amgen shares opened marginally lower. At last check the stock was down 0.07% to $53.52.

Amgen is a Thousand Oaks, California-based independent biotechnology Medicines Company, engaged in the discovery, development, manufacturing and marketing of medicines for serious illnesses. The company is focuses on medicines based on advance in cellular and molecular biology.

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