Sorry!! The article you are trying to read is not available now.
Thank you very much;
you're only a step away from
downloading your reports.

Review of Biogen Idec's MS Drug Delayed

By

Shares of the giant biotech company dipped on news that an FDA review of the promising new pill BG-12 is being extended by three months. If the drug is approved, Wall Street analysts expect Biogen will take market share from Novartis' Gilenya.

PrintPRINT
MINYANVILLE ORIGINAL Investors have been eagerly awaiting an approval of Biogen Idec's (NASDAQ:BIIB) promising new drug to treat multiple sclerosis, a product many believe will be a blockbuster. They'll have to wait a bit longer as Biogen says US officials need more time to review the drug, known as BG-12.

The US Food and Drug Administration is extending its review time by three months past the original deadline date of December 28, Biogen says. The company says only that the agency needs more time to review the application and the FDA is not asking for additional studies. That makes a first-quarter launch of the drug unlikely but the extension itself doesn't necessarily mean bad news. So far, there are no signals that the drug won't be approved.

Shares of Biogen dipped more than 2% to $150.47 in morning trading Thursday. The stock has been on a tear this year, rising 37%, which is huge for a company with a $36 billion market cap.

Just last week, Biogen reported more data showing that BG-12, a pill, appears to be effective and generally safe for patients. That news further fueled investor excitement about the drug.

"BG-12 is poised for blockbuster potential," Leerink Swann analyst Marko Kozul says in a recent note. What's more, doctors' feedback "leads us to believe the Street's apparent enthusiasm for BG-12 is well founded."

If approved, Biogen's pill would go up against Novartis' (NSE:NVS) Gilenya, the first oral medicine approved for MS. Historically, drugs for the disease were injected or infused. Gilenya was introduced to the market in late 2010. Despite Novartis' head start, analysts expect Biogen's drug will take market share from Gilenya. Biogen's drug study data has been very good.

MS is a chronic disease of the central nervous system. It's considered an autoimmune disease, which means the body's immune system attacks healthy tissue. Usually diagnosed between the ages of 20 and 40, the disorder affects women more than men. About 400,000 Americans have MS, according to estimates from the National Multiple Sclerosis Society.

Twitter: @brettchase

Follow the markets all day every day with a FREE 14 day trial to Buzz & Banter. Over 30 professional traders share their ideas in real-time. Learn more.
< Previous
  • 1
Next >
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.

Copyright 2011 Minyanville Media, Inc. All Rights Reserved.
PrintPRINT

Busy? Subscribe to our free newsletter!

Submit
 

WHAT'S POPULAR IN THE VILLE