FDA approves Biogen's oral MS drug, Tecfidera
`WASHINGTON | BY TONI CLARKE
`
`A pedestrian passes the sign outside the headquarters of Biogen ldec Inc. in Cambridge, Massachusetts June 18, 2008.
`REUTERS/BRIAN SNYDER
`
`U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen
`Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with
`annual sales topping $3 billion.
`
`The drug, Tecfidera, activates a chemical pathway in the body known as NrT2 that helps
`protect nerve cells from damage and inflammation. Following Wednesday's approval by the
`Food and Drug Administration, Biogen said it will launch the drug within the coming days.
`
`Multiple sclerosis is a chronic condition that attacks the central nervous system and can
`lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million
`people worldwide, according to the National Multiple Sclerosis Society.
`
`"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in
`the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said
`in a research note. "However, we believe that Street expectations likely already account for
`this and then some."
`
`Shares of Weston, Massachusetts—based Biogen rose 3.2 percent to close at $182.68 on
`Wednesday. The shares have more than tripled over the past three years, mainly driven by
`high hopes for Tecfidera, known chemically as dimethyl fumarate.
`
`Biogen already sells the MS drugs Avonex and Tysabri, which together account for about
`30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the
`current market leader, with a roughly 29 percent share and annual sales last year of more
`than $4 billion.
`
`Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in
`the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill
`Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya
`holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last
`yean
`
`Page 1 of 2
`
`Biogen Exhibit 2070
`Coalition v. Biogen
`IPR2015-01993
`
`

`
`Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's
`
`label carries a boxed warning —— the most serious kind of warning —— alerting physicians to a
`
`potentially heightened risk of liver problems.
`
`Novartis said in a statement that it welcomed additional treatment options for people with
`
`MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.
`
`"As with any new medication, real—world experience is critical to gain an accurate
`
`understanding of a therapy's full clinical profile," the company said. ''It will be important to
`
`see the clinical profile of dimethyl fumarate —— including efficacy, safety, tolerability and
`
`adherence with its twice—a—day dosing —— as it gains real—world experience."
`
`Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks
`
`"significantly better than Gi|enya."
`
`Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and
`
`nausea. And its label contains no boxed warnings. The FDA recommended only that
`
`physicians monitor patients‘ infection—fighting white blood cell count once a year.
`
`"That's an excellent |abe|," said Yee. ''I expect the drug to meet consensus of $300 million
`
`this year, and over five years it can achieve greater than $3 billion in sales based on its
`
`convenience and efficacy profile."
`
`Tecfidera will be used to treat patients with re|apsing—remitting MS, a form of the disease in
`
`which f|are—ups are followed by periods of remission. About 85 percent of people with MS
`
`are initially diagnosed with this form of the disease.
`
`Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent
`
`after two years compared to patients taking a placebo. The drug is expected to generate
`
`sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis.
`
`Last week European regulators recommended approval for Tecfidera and Aubagio, but they
`
`declined to give Aubagio a "new active substance" designation because it is similar to an
`
`older drug. Without this designation, generic copies of the drug could be launched in
`
`Europe in as little as three years. That could hurt sales of most other MS drugs on the
`market.
`
`Sanofi said it was disappointed by the decision and plans to request a re—examination of
`the case.
`
`(Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York;
`
`Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)
`
`Page 2 of 2
`
`Page 2 of 2