FRONT PAGE AMPYRA AUBAGIO AVONEX BETASERON COPAXONE EXTAVIA
Stan's Angels MS News Channel on YouTube GILENYA NOVANTRONE REBIF RITUXAN TECFIDERA TYSABRI
 THE AVONEX CHANNEL
Click Here For My Videos, Advice, Tips, Studies and Trials.
Timothy L. Vollmer, MD
Department of Neurology
University of Colorado Health Sciences Center Professor

Co-Director of the RMMSC at Anschutz Medical Center

Medical Director-Rocky Mountain MS Center
Click here to read my columns
Brian R. Apatoff, MD, PhD
Multiple Sclerosis Institute
Center for Neurological Disorders

Associate Professor Neurology and Neuroscience,

Weill Medical College of Cornell University

Clinical Attending in Neurology,
New York-Presbyterian Hospital
CLICK ON THE RED BUTTON BELOW
You'll get FREE Breaking News Alerts on new MS treatments as they are approved
MS NEWS ARCHIVES: by week
March 2005   
April 2005   
June 2005   
July 2005   
August 2005   
September 2005   
October 2005   
November 2005   
May 2006   
June 2006   
July 2006   
October 2006   
April 2010   
May 2013   
June 2013   
July 2013   
August 2013   
July 2014   
November 2014   
January 2015   
February 2015   
April 2015   
July 2015   
January 2016   
March 2016   

HERE'S A FEW OF OUR 6000+ Facebook & MySpace FRIENDS
Timothy L. Vollmer M.D.
Department of Neurology
University of Colorado Health Sciences Center
Co-Director of the RMMSC at Anschutz Medical Center
and
Medical Director-Rocky Mountain MS Center


Click to view 1280 MS Walk photos!

"MS Can Not
Rob You of Joy"
"I'm an M.D....my Mom has MS and we have a message for everyone."
- Jennifer Hartmark-Hill MD
Beverly Dean

"I've had MS for 2 years...this is the most important advice you'll ever hear."
"This is how I give myself a painless injection."
Heather Johnson

"A helpful tip for newly diagnosed MS patients."
"Important advice on choosing MS medication "
Joyce Moore


This page is powered by Blogger. Isn't yours?

Sunday

 

Biogen Idec inc Earnings Were Great. Here's Why the Stock Tumbled Anyway

















There's nothing like the disclosure of a side effect to ruin a perfectly good earnings report. Despite meeting analyst expectations on revenue, and beating on the earnings-per-share side, Biogen Idec traded down more than 10% at one point today after announcing that a patient taking its oral multiple sclerosis drug Tecfidera contracted progressive multifocal leukoencephalopathy, or PML.

PML is a potentially lethal brain infection caused by a rather benign virus that can become active in patients with weakened immune systems. The patient actually died from complications from pneumonia; but that doesn't change the fact that the patient had PML.

The patient was treated with Tecfidera for 4.5 years as part of one of the clinical trials, and came down with severe lymphopenia, or low lymphocytes, the white blood cells responsible for fighting infections.This isn't particularly surprising; in the clinical trials, Tecfidera lowered lymphocytes by approximately 30% during the first year of treatment. There's a warning on its label about lymphopenia, which is known to be a risk factor for developing PML and other infections.

PML was responsible for another one of Biogen Idec's multiple sclerosis drugs, Tysabri, being pulled off the market. The FDA eventually decided the benefits of the drug outweighed its risk, and let Tysabri back on the market.

There's now a test for the virus that causes PML, which can make doctors and patients feel comfortable using the product if the test is negative. Some patients accept the risk even if they test positive, because Tysabri works so well at controlling multiple sclerosis symptoms. The risk, however, has certainly muted sales of Tysabri.

If patients started making the same kinds of choices with Tecfidera, it would be disastrous for Biogen Idec. The new medication has not only become the top-selling oral multiple sclerosis drug, but sales have surpassed Tysabri and Biogen Idec's bellwether, Avonex.

At this point, I doubt that would happen. It's only one case of PML, and there's a plausible explanation for why it occurred. The PML case will make doctors more conscious of testing for lymphopenia -- something they're supposed to be doing anyway -- and might cause discontinuations in patients that develop it, especially if that's what the FDA recommends. Six percent of patients taking Tecfidera had lymphocyte counts less than about half of the normal level, so discontinuations because of lymphopenia could cut into revenue, but wouldn't be disastrous.

With that negative news out of the way...
It really was a nice quarter. Revenue increased 37%, thanks to a solid quarter for its multiple sclerosis drugs. Tecfidera sales were up 12% quarter over quarter, capturing a third of new patient starts, and more than 40% of patients switched medications. Biogen Idec's new hemophilia franchise is off to a good start with $25 million in sales of Alprolix, up from $10 million last quarter, and Eloctate sales of $21 million in its first quarter on the market.

Adjusted earnings per share increased 61% year over year, although that was partially due to flat spending on research and development, which isn't a long-term positive. But the increase allowed Biogen Idec to increase non-GAAP guidance to between $13.45 and $13.55 for the year.

Story Source: The above story is based on materials provided by NASDAQ
Note: Materials may be edited for content and length
Click here to read original article

Labels: , , ,