Biogen Faces Delay in FDA Action Date - Analyst Blog


Biotech company, Biogen Idec ( BIIB ), well known for its strong presence in the multiple sclerosis (MS) market, is facing a delay in the approval process for its MS pipeline candidate, Plegridy. Biogen is looking to get Plegridy, a subcutaneous pegylated interferon candidate, approved for relapsing forms of multiple sclerosis (RMS).

The FDA informed the company that it is extending the review period by three months. This means that a response from the FDA should now be out in the second half of the year instead of mid-14 as had been expected earlier. The agency did not ask Biogen to conduct additional studies. The review period was extended to provide additional time for the review to be conducted.

Plegridy is under review in the EU as well where a response should be out in the second half of the year.

Biogen's MS portfolio consists of drugs like Avonex, Tysabri and the recently launched oral MS treatment, Tecfidera. Tecfidera is off to a strong start in the U.S. and already holds a leading position in the oral MS market. We expect the drug to do well in the EU too where it was launched recently.

Biogen is working on consolidating its position in the MS market. In addition to Plegridy, Biogen has daclizumab in its MS pipeline. Biogen and partner AbbVie ( ABBV ) are conducting a two-year phase III study (DECIDE) on daclizumab with results due later this year. Biogen is also looking to expand Tysabri's label and is conducting a phase IIIb study (ASCEND) in combination with daclizumab in patients with secondary-progressive MS - results are expected in 2015.

The delay in Plegridy's approval date should not be a matter of major concern. The important thing is that the FDA has not asked for additional studies to be conducted.

Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include companies like Gilead Sciences Inc. ( GILD ) and Alexion Pharmaceuticals, Inc. ( ALXN ). Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: MS , ABBV , ALXN , BIIB , GILD

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