By Bill Berkrot (Reuters) - Biogen Idec Inc said on Wednesday sales of its big-selling new multiple sclerosis drug Tecfidera fell short of Wall Street's lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares 7 percent lower. Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years. The patient, who died of pneumonia, had been suffering severe lymphopenia, a low white blood cell condition, for more than three years, which Biogen said was a risk factor for developing PML. Biogen, which has notified health regulators of the PML case, said 100,000 patients have taken Tecfidera. The drug, which has far exceeded expectations since its March 2013 U.S. approval, had sales of $787 million in the third quarter. Analysts, who in previous quarters had watched Tecfidera sail past their sales estimates, were looking for about $800 million. "We've always expected that Tecfidera's growth rate would moderate over time," Tony Kingsley, Biogen's head of commercial operations, said on a conference call. Shares of the U.S. biotechnology company fell $22.55 to $304.21 on Nasdaq at mid-afternoon. While Tecfidera has had a clean safety record throughout its clinical trials and commercial use, PML has long been a concern associated with long-term treatment of MS drugs. Biogen's injectable MS drug Tysabri was pulled from the market in February of 2005 after three cases of the rare brain infection - two of them fatal - were reported among users. U.S. health regulators allowed it back on the market with certain restrictions in June 2006 after campaigning by patients who felt the medicine was so effective they were willing to take on the PML risk. "We think the risk/benefit is clearly still in favor of using Tecfidera for nearly all patients," said RBC Capital Markets analyst Michael Yee. Biogen reported a higher-than-expected quarterly profit and raised its full-year earnings forecast, primarily on lower business development and research and development spending expectations. It now estimates 2014 earnings per share of $13.45 to $13.55, up from its previous forecast of $12.90 to $13.10, excluding items. "For a company that's been beating and crushing numbers, it's hard to see people getting terribly excited about this," Sanford Bernstein analyst Geoffrey Porges said. "You have to wonder if this is the new normal for Biogen or whether they can resume that spectacular growth." Biogen's net profit jumped to $856.1 million, or $3.62 per share, from $487.6 million, or $2.05 per share, a year ago. Excluding items, Biogen earned $3.80 per share, exceeding analysts' average expectations by 34 cents, according to Thomson Reuters I/B/E/S. Revenue rose 37 percent to $2.5 billion, roughly in line with estimates of $2.48 billion. Tysabri had sales of $501 million, beating analyst expectations of about $485 million. The company's interferon-based MS drugs, Avonex and new longer-acting Plegridy, had combined sales of $745 million, missing Wall Street estimates of about $767 million. Avonex has lost market share to Tecfidera. Biogen said 40 percent of patients switching MS treatments have chosen Tecfidera. "With all of their MS products you have to wonder is there enough incremental revenue to support continued growth or are they just cannibalizing the rest of their franchise every time they launch a new product," Porges said. (Reporting by Bill Berkrot in New York; Editing by Jeffrey Benkoe, Chizu Nomiyama, Paul Simao and Richard Chang)
Our goal is to create a safe and engaging place for users to connect over interests and passions. In order to improve our community experience, we are temporarily suspending article commenting
TikTok of sleep hack developed by the military to make you fall asleep in under 2 minutes goes viral
Filipino fitness trainer and TikTok influencer Justin Agustin went viral for demonstrating a military technique to help one fall asleep in two minutes. Agustin posted the TikTok video last week with the caption: “Technique to falling asleep in 2 minutes!” and it has since garnered over 6.6 million views and nearly 500,000 likes, as of this writing.
- Miami Herald
“You have changed my life forever,” one user wrote after discovering the feature.
- NBC Sports Washington
Charles Mann told the Sports Junkies on Wednesday that he is "not happy" with the new name that Washington settled on.
NY Attorney General Tish James says Trump changed his mind about her investigation into his company only after being subpoenaed for a deposition
In a new filing, New York Attorney General Letitia James claims Trump filed a lawsuit only so he could wriggle his way out of taking a deposition.
- Business Insider
Watch as a snowplow driver launches a spray of slush into oncoming highway traffic, leading to a 40-car accident on the Ohio Turnpike
The driver was immediately removed from their shift and placed on administrative leave, the turnpike commission's director said in a statement.
- In The Know by Yahoo
Little boy has sweetest reaction when he spots parents in audience: ‘Proof that being present can make a big difference’
His whole face changed the second he saw them, and the footage is going viral.
- Best Life
Even though the world has been dealing with the COVID-19 pandemic for nearly two years, we're still learning about the virus and how it can affect our bodies. One area of understanding that has been particularly difficult to grasp has been the wide range of symptoms the virus can cause and how some can stick around long after recovery. Now, a new study has found that one symptom is having a long-term effect on about half of people who have caught COVID. Read on to see which ailment could be stic
Sen. Lindsey Graham says Democrats will likely be able to replace Supreme Court Justice Stephen Breyer without any Republican support: 'Elections have consequences'
"If all Democrats hang together ... they have the power to replace Justice Breyer in 2022 without one Republican vote in support," Graham said.
- The Providence Journal
Computer models continue to "boost confidence" that Southern New England will get hit with "a high impact winter storm" Saturday.
- Fort Worth Star-Telegram
The creature was found after a Crime Stoppers tip.
- KABC – Los Angeles
The family of an active mother of three who was allegedly refused the COVID-19 vaccine multiple times, is filing a wrongful death lawsuit against Kaiser.
- CBS News Videos
Bill of the Month: Hospital charges family over $1,000 even though they were not treated by a doctor
Dhaval Bhatt's toddler went to the emergency room after he burned his hand on the stove. His son was not seen by a doctor, but Bhatt's hospital bill still totaled more than $1,000. Kaiser Health News' Editor-in-Chief Dr. Elisabeth Rosenthal breaks down how this happened and what you should know before visiting an emergency room.
- Lubbock Avalanche-Journal
The Olton-Farwell boys basketball game on Tuesday night was postponed after officials left following the girls game.
- Women's Health
Alexandra Daddario's ultra-toned abs and killer booty are total #goals in these new Instagram photos. Hot yoga and AMRAP workouts are her fitness go-tos.
- Ravens Wire
Multiple Ravens' players reacted on Twitter to Antonio Brown posting a picture of himself in a Baltimore jersey
Is this transitional dressing?
- Celtics Wire
B/R trade proposal sees Boston swapping a beloved face and a new arrival for an Atlanta Hawks big man
The fit is sound, but would it make both teams better?
- Kansas City Star
”I just wish I could do what I want without getting attacked every week,” tweeted Brittany Matthews, co-owner of Kansas City Current and fiancee of Chiefs quarterback Patrick Mahomes.
- Knox News | The Knoxville News-Sentinel
Tennessee basketball topped Florida 78-71 on Wednesday night at Thompson-Boling Arena. The teams had a contentious postgame handshake.
The former president's son received a quick reminder about his father.