贴身特工梁七少txt:Promising results on MS pill’s trial send Biogen Idec shares soaring

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Promising results on MS pill’s trial send Biogen Idec shares soaring

Weston-based Biogen Idec now has two major multiple sclerosis drugs. It is developing a third MS drug, a pill. (Joanne Rathe/Globe Staff/File) By Erin Ailworth Globe Staff / April 22, 2011  A clinical trial of a Biogen Idec Inc. pill to treat the most common form of multiple sclerosis showed that the experimental drug works extremely well, pushing the Weston biotechnology company’s stock price up by as much as 24 percent in trading yesterday.

The company — which hopes to seek approval for the drug from federal regulators early next year — said the pill marks a significant advancement in treatment of multiple sclerosis by helping protect cells from damage and inflammation caused by the debilitating disease. MS, which affects about 400,000 people in the United States, attacks the central nervous system. Over time, it causes worsening symptoms, ranging from numbness of limbs to paralysis, and is marked by painful flare-ups.

If Biogen Idec’s treatment turns out to be as effective as tests indicate, the drug will be “poised to dominate’’ an emerging market for MS drugs that can be swallowed instead of taken through infusions or injections, according to Joshua Schimmer, an analyst at health care investment bank Leerink Swann in New York. Schimmer estimated the market for MS treatments at “north of $10 billion.’’

The possibility of a new MS treatment, especially a pill, “is something that everybody is happy about,’’ said Steve Sookikian, a spokesman for the Greater New England Chapter of the National Multiple Sclerosis Society. The group represents about 19,000 patients in Maine, Massachusetts, New Hampshire, and Vermont.

“Oral therapies offer people with MS an opportunity to stop stabbing themselves with needles,’’ Sookikian said. “However, people with MS have to carefully consider the pros and cons of therapies. If they are doing well on a therapy, just because it’s an injectable doesn’t mean they should stop taking it.’’

Biogen Idec is known for sophisticated biotechnology drugs, but the MS pill doesn’t fall into that category since it isn’t made from living cells. The treatment would compete with Gilenya, the only MS pill now on the market. That drug, approved by the Food and Drug Administration in September, is made by Swiss drug giant Novartis AG, which has its research and development headquarters in Cambridge.

Analysts, while impressed by the latest trial results for Biogen Idec’s drug — known as BG-12 — cautioned that more testing is needed to determine whether the treatment is safe and effective enough for doctors to prescribe it to thousands of people.

“It’s important to get a better understanding of how it works,’’ Schimmer said. “What’s our confidence that when the dust settles BG-12 is going to remain this very active, potent drug?’’

In a 7 a.m. call with analysts yesterday, chief executive George A. Scangos said data from a two-year trial of BG-12 demonstrated “top-line results.’’ By 10:30 a.m., Biogen Idec’s stock had hit $106.99 on the Nasdaq exchange, up nearly 24 percent from Wednesday’s closing price of $86.57. The price moderated later in the day to close up by about 15 percent.

The company tested the drug on more than 1,200 patients who took a 240-milligram pill either two or three times a day. According to Biogen Idec, the trial showed a “significant reduction’’ in the proportion of patients who suffered relapses at two years compared with a placebo.

Doug Williams, Biogen Idec’s executive vice president of research and development, said BG-12 is essentially an “immune modulator and neuroprotective drug,’’ meaning it helps protect cells from stress and damage. The company expects to release additional test results from another trial of about 1,400 patients later this year.

“If we can replicate what we saw,’’ Williams said, “then we feel like we’ve got a very competitive drug in the marketplace and one that is going to provide substantial benefit to MS patients.’’

Biogen Idec, the largest biotech company in Massachusetts, already sells two major MS drugs, Avonex and Tysabri. About 140,000 patients use Avonex, while about 58,400 take Tysabri, the company said. Tysabri, while considered highly effective, has been associated with a rare but often fatal brain infection known as progressive multifocal leukoencephalopathy, or PML. The company has been working to limit the risk by better identifying which patients are most likely to contract PML.

Currently, Biogen Idec’s MS treatments account for 30 percent of the total market, according to Schimmer. Adding BG-12 to the roster would make it “the MS player to beat,’’ he said.

Biogen Idec investors yesterday were also buoyed by the company’s earnings report. It showed $294.3 million in profits for the first three months of the year, an increase of $77 million, or 35 percent, from the same period in 2010. The company attributed the change to improved sales of Avonex and Tysabri. Revenue from Tysabri increased 15 percent to $251 million, while Avonex generated $642 million for the quarter, up 8 percent from the same period last year.

“We’re off to a great start for 2011,’’ Scangos said. “This was quite a quarter.’’

Erin Ailworth can be reached at eailworth@globe.com.

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