(AMGN) Amgen Drug Earns Positive Committee for Medicinal Products for Human Use Opinion

Amgen (AMGN) recently announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a label expansion for its oncology product, Vectibix.

Amgen is looking to gain EU approval for the use of Vectibix in patients with wild-type KRAS metastatic colorectal cancer (mCRC) as a first-line treatment in combination with FOLFOX and second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

The CHMP had previously adopted a negative opinion regarding Amgen’s marketing authorization application for Vectibix’ label expansion. Amgen filed an appeal against the decision in March 2011 requesting the EMA to re-examine the CHMP’s opinion.

With the CHMP now changing its view, a final decision from the European regulatory authority regarding Vectibix’ label expansion should be out shortly.

Amgen is looking to drive Vectibix sales by expanding its label. Results from two studies (PRIME and ‘181) showed that Vectibix plus chemotherapy improved progression-free survival in patients with wild-type KRAS mCRC compared to only chemotherapy. Moreover, Amgen reported a higher response rate in the Vectibix arm compared to chemotherapy alone.

Vectibix is currently approved in several countries as a monotherapy treatment for wild-type KRAS mCRC patients who are no longer responding to standard chemotherapy. Meanwhile, Vectibix is approved in the US as a monotherapy treatment for patients with EGFR-expressing mCRC after the disease has progressed following or while on treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The colorectal cancer market represents huge potential. According to estimates provided by the company in its press release, about 1.23 million cases of colorectal cancer were diagnosed across the world in 2008. In the EU alone, about 333,330 new cases of colorectal cancer were diagnosed in 2008.

Amgen is currently seeking US approval for the use of Vectibix for first- and second-line mCRC. Vectibix’ primary competitor is Eli Lilly/Bristol-Myers Squibbs’ (LLY/BMY) Erbitux.

Neutral on Amgen

We currently have a Neutral recommendation on Amgen. We expect investor focus to remain on the successful commercialization of Prolia/Xgeva.

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