*from www.bloomberg.com, Mar. 28, 2013 (To view original article click here.)
Take Away #1: Biogen Idec Inc., the fourth largest U.S. biotech company by market value, rose to a record after it won U.S. approval for its first pill for multiple sclerosis, Tecfidera.
Key Facts and Figures:
- Biogen gained 3.5% to $189.09 at 9:53 a.m. in New York.
- Biogen rose 3.2% the previous day on news that the FDA granted the medicine marketing approval.
- The shares are at their highest price since the company first sold stock in publicly in September 1991.
Take Away #2: Tecfidera, formerly known as BG-12, may generate $3.25 billion in annual revenue by 2017.
Key Facts and Figures:
- The drug follows Novartis AG’s Gilenya and Sanofi’s Aubagio to the market as oral options for MS.
- Multiple sclerosis or MS, affects 2.1 million worldwide, according to the National MS Society.
- Forecasts from the 79 economists surveyed ranged from 0.1% to 0.8%.
Take Away #3: The FDA announced the approval yesterday.
Key Facts and Figures:
- The drug is recommended to be taken twice a day and will be made available to patients in the U.S. in the coming days, said Biogen.
- Tecfidera was shown in two studies to reduce patient’s annual relapse rate by 49% when given either twice a day or three times a day.
- It cut the proportion of patients who relapsed by 43% at twice-daily dosing and 47% at three times daily, compared with placebo.
- Side effects were similar across the placebo and treatment groups, the most common adverse events being flushing and gastrointestinal effects, according to Biogen.
- The FDA recommended that a patient’s white blood cell count be assessed before starting treatment with the pill.
Take Away #4: Biogen shares gained over the past 12 months on positive data from a late-stage trial of Tecfidera.
Key Facts and Figures:
- The drug was recommended for marketing approval by European Union health regulators on March 22, the same day as Sanofi’s Aubagio.
- Sanofi’s Aubagio is already approved in the U.S. though its efficacy profile is not that impressive versus other oral compounds.
- Analysts estimate the medicine will have 2017 sales of 718 euros ($917 million).
- They climbed 3.1% from the same time in 2011.
Take Away #5: Novartis’ Gilenya, the first oral treatment approved for MS, has safety issues that hamper its widespread use.
Key Facts and Figures:
- 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 should not 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.
Take Away #6: With the FDA approval of Tecfidera, Biogen will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill, says Biogen.
Key Facts and Figures:
- Biogen also makes the MS drugs Avonex, administered by injection, and Tysabri, given through intravenous infusion.
- Tecfidera may be priced at $50,000 to $55,000 a year.
- Gilenya is priced at $58,000 and Aubagio is priced at $45,000 a year.
- Analyst Michael Yee of RBC Capital Markets says, “We believe this is an attractive pricing level given Tecfidera’s combined efficacy and safety profile.”
*To view original article from www.bloomberg.com click here.