Biogen Gains U.S. Approval to Sell Its First Pill for MS
By Meg Tirrell -
Mar 27,
Biogen Idec Inc. (BIIB), the maker of
multiple sclerosis drugs Avonex and Tysabri, won U.S. approval
for its first pill for the disease, Tecfidera, a medicine
analysts project will dominate the MS market.
The drug, formerly known as BG-12, may generate $3.25 billion in annual revenue by 2017 for the Weston, Massachusetts-based company, according to the average of eight analysts’ estimates compiled by Bloomberg.
Tecfidera was shown in two studies to reduce patients’ annual relapse rate by 49 percent when given either twice a day or three times a day. It cut the proportion of patients who relapsed by 43 percent at twice-daily dosing and 47 percent at three times daily compared with placebo.
Side effects were similar across the placebo and treatment groups, with the most common adverse events associated with Tecfidera being flushing and gastrointestinal effects, according to the company.
The FDA recommended that a patient’s white blood cell count be assessed before starting treatment with the pill. While the medicine may decrease these infection-fighting cells, no significant increase in infections was seen in patients taking Tecfidera in clinical trials, the agency said in its statement.
“Relative to other MS drugs, such as Tysabri and Gilenya, this basic test is a much less invasive requirement,” Andrew Berens, an analyst with Bloomberg Industries, wrote today in a research note.
Biogen Stock Price:
The shares rose to their highest price ever.
Biogen shares rose 3.2 percent to $182.68 at the close in New York, the highest price since the stock was first offered to the public in September 1991. The company has gained 45 percent in the last 12 months and doubled since April 2011 when Biogen first reported positive data from a late-stage trial of Tecfidera.
The drug was recommended for marketing approval by European Union health regulators on March 22, the same day as Paris-based Sanofi’s Aubagio, another oral option for MS. Aubagio already is approved in the U.S.
Though Sanofi’s drug Aubagio has the advantage of being a pill, its “efficacy profile is not that impressive versus other oral compounds,” Asthika Goonewardene, an analyst for Bloomberg Industries in London, said in a telephone interview. Analysts estimate the medicine will have 2017 sales of 718 million euros ($917 million).
Basel, Switzerland-based Novartis’s Gilenya, the first oral treatment approved for MS, has safety issues that hamper its widespread use. U.S. and European regulators placed new safety precautions on the drug’s use last year after a three-month review triggered by the deaths of 15 patients. Doctors shouldn’t prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication, regulators said. Analysts expect 2017 revenue of $2.7 billion, according to the average of 10 estimates compiled by Bloomberg.
Summary: Tecfidera
“With the FDA approval of Tecfidera, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill -– a combination we believe will have a significant positive impact on the way people live with this chronic disease,” Biogen Chief Executive Officer George Scangos said in the company’s statement.
“We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy.”
The drug may be priced at $50,000 to $55,000 a year, lower than Gilenya at $58,000 and higher than Aubagio at $45,000, said Michael Yee, an RBC Capital Markets analyst in San Francisco.
“We believe this is an attractive level of pricing given Tecfidera’s combined efficacy and safety profile,” he wrote today in a research note.
Because of its efficacy, safety and dosing convenience, Tecfidera may gain as much as 20 percent of the market in its first year, Cowen & Co. analyst Eric Schmidt projects.
“It really is going to be a great addition to the toolbox,” Timothy Coetzee, chief research officer of the National Multiple Sclerosis Society, said in an interview before the approval was announced. “There seems to be quite a lot of patient awareness about it.
The drug, formerly known as BG-12, may generate $3.25 billion in annual revenue by 2017 for the Weston, Massachusetts-based company, according to the average of eight analysts’ estimates compiled by Bloomberg.
Clinical Trials
The approval was announced by the Food and Drug Administration today in a statement. The drug is recommended to be taken twice a day and Biogen will make Tecfidera available to patients in the U.S. in the coming days, the company said in a statement.Tecfidera was shown in two studies to reduce patients’ annual relapse rate by 49 percent when given either twice a day or three times a day. It cut the proportion of patients who relapsed by 43 percent at twice-daily dosing and 47 percent at three times daily compared with placebo.
Side effects were similar across the placebo and treatment groups, with the most common adverse events associated with Tecfidera being flushing and gastrointestinal effects, according to the company.
The FDA recommended that a patient’s white blood cell count be assessed before starting treatment with the pill. While the medicine may decrease these infection-fighting cells, no significant increase in infections was seen in patients taking Tecfidera in clinical trials, the agency said in its statement.
“Relative to other MS drugs, such as Tysabri and Gilenya, this basic test is a much less invasive requirement,” Andrew Berens, an analyst with Bloomberg Industries, wrote today in a research note.
Biogen Stock Price:
The shares rose to their highest price ever.
Biogen shares rose 3.2 percent to $182.68 at the close in New York, the highest price since the stock was first offered to the public in September 1991. The company has gained 45 percent in the last 12 months and doubled since April 2011 when Biogen first reported positive data from a late-stage trial of Tecfidera.
Competitors
Tecfidera follows Novartis AG (NOVN)’s Gilenya and Sanofi (SAN)’s Aubagio to the market as oral options for MS, a central nervous system disease otherwise treated by injection or infusion.The drug was recommended for marketing approval by European Union health regulators on March 22, the same day as Paris-based Sanofi’s Aubagio, another oral option for MS. Aubagio already is approved in the U.S.
Though Sanofi’s drug Aubagio has the advantage of being a pill, its “efficacy profile is not that impressive versus other oral compounds,” Asthika Goonewardene, an analyst for Bloomberg Industries in London, said in a telephone interview. Analysts estimate the medicine will have 2017 sales of 718 million euros ($917 million).
Basel, Switzerland-based Novartis’s Gilenya, the first oral treatment approved for MS, has safety issues that hamper its widespread use. U.S. and European regulators placed new safety precautions on the drug’s use last year after a three-month review triggered by the deaths of 15 patients. Doctors shouldn’t prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication, regulators said. Analysts expect 2017 revenue of $2.7 billion, according to the average of 10 estimates compiled by Bloomberg.
Summary: Tecfidera
“With the FDA approval of Tecfidera, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill -– a combination we believe will have a significant positive impact on the way people live with this chronic disease,” Biogen Chief Executive Officer George Scangos said in the company’s statement.
“We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy.”
The drug may be priced at $50,000 to $55,000 a year, lower than Gilenya at $58,000 and higher than Aubagio at $45,000, said Michael Yee, an RBC Capital Markets analyst in San Francisco.
“We believe this is an attractive level of pricing given Tecfidera’s combined efficacy and safety profile,” he wrote today in a research note.
Because of its efficacy, safety and dosing convenience, Tecfidera may gain as much as 20 percent of the market in its first year, Cowen & Co. analyst Eric Schmidt projects.
“It really is going to be a great addition to the toolbox,” Timothy Coetzee, chief research officer of the National Multiple Sclerosis Society, said in an interview before the approval was announced. “There seems to be quite a lot of patient awareness about it.
Alessandro Bianchi/Press Pool 
