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The Zacks Analyst Blog Highlights: Sanofi, Regeneron, Amgen, InterMune and XOMA

Zacks Equity Research

For Immediate Release
Chicago, IL – March 13, 2014 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Sanofi (SNY-Free Report), Regeneron (REGN-Free Report), Amgen (AMGN-Free Report), InterMune (ITMN-Free Report) and XOMA Corporation (XOMA-Free Report).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.

Here are highlights from Wednesday’s Analyst Blog:

Biogen Stock Roundup

Late last week, companies developing PCSK9 inhibitors saw a fall in their share price with the FDA raising concerns about this class of drugs. PCSK9 inhibitors work by inhibiting PCSK9, a protein that reduces the liver's ability to remove "bad" cholesterol from the blood.

Although statins (the current standard of treatment) are effective, many patients have problems achieving their cholesterol goals. Moreover, several patients are unable to tolerate statin therapy. In such a scenario, the successful development of PCSK9 inhibitors would be a major breakthrough in the area of cholesterol management. While results on PCSK9 inhibitors in development have been encouraging so far, this is the first time that serious safety concerns have been raised.

The FDA has raised concerns about neurocognitive adverse events in the PCSK9 inhibitor class. These are events that are also associated with the use of statins. So will PCSK9 inhibitors eventually prove to be better than statins as was assumed before?

Sanofi (SNY-Free Report) and Regeneron (REGN-Free Report), who are developing PCSK9 inhibitor alirocumab, disclosed that they have been advised by the FDA regarding the issues though neither company is aware of the circumstances under which the FDA became aware of these adverse events.  So questions like did the FDA notice these events when the PCSK9 inhibitor was being tested as a monotherapy or when it was being tested in combination with a statin or another cholesterol treatment remain.

These companies have been told to evaluate potential neurocognitive adverse events across the global development program for the experimental drug, especially in long-term studies. The FDA has also raised the possibility of incorporating neurocognitive testing in at least a subset of patients in late-stage studies.

With the news about the FDA’s concerns spreading like wildfire, Regeneron saw its shares sliding 3.1%. Amgen’s (AMGN-Free Report) shares were down 1.6%. Amgen’s PCSK9 inhibitor, evolocumab, is currently in late-stage development with regulatory filing expected this year itself. The FDA will most likely ask all these companies to evaluate neurocognitive adverse events in long-term studies.

InterMune (ITMN-Free Report) Soars on Takeover Rumors: InterMune shares were up 10.8% on rumors that it is an acquisition target. The acquisition rumors do not come as a surprise; just a few days back, InterMune scored a huge win in a late-stage study conducted on its lung disease drug, Esbriet. The results are compelling enough for the company to succeed in gaining FDA approval for the product which is already approved in the EU.

Approval in the U.S. would boost sales of the drug significantly. Esbriet sales were $70.3 million in 2013. Given Esbriet’s improving prospects, quite a few pharma companies would be interested in acquiring the company.

Pipeline Setback Overshadows XOMA Corporation’s (XOMA-Free Report) Fourth Quarter Results: XOMA’s fourth quarter results were overshadowed by the company’s announcement that it will not be moving gevokizumab into phase III studies for erosive osteoarthritis of the hand. Shares were down 27.8%.

Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.

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