Regulators Grant Biogen a Big Win but AB Science Loses Out

November 25, 2013 Regulators grant Biogen a big win but AB Science loses out

Jonathan Gardner

A spate of regulatory decisions to close last week affected company valuations on both sides of the Atlantic, with a big rise in market valuation for Biogen Idec, Ariad Pharmaceuticals and Medivir, and a major loss for AB Science.

The biggest news was a European Medicines Agency recommendation to award Biogen’s multiple sclerosis drug Tecfidera “new active substance” status, a decision that will allow the Massachusetts group to fend off generic challenges and shield an estimated 40% of its sales. Meanwhile, a vote against masitinib in gastrointestinal stromal cancer sent shares of AB Sciences into a tailspin.

Big thumbs up

The EMA’s human medicines committee had backed Tecfidera in March, but a decision over whether the twice- daily pill qualified for data exclusivity as part of a new active substance ruling was put off.

This status affords 10 years of data protection, without which it would have to rely on use patents, which could be found unenforceable; Tecfidera’s active substance, dimethyl fumarate, has been available in Germany in a compounded form called Fumaderm since 1994 and has lost its own patent protection as a psoriasis drug (Event – 40% of Tecfidera’s sales hangs in the balance, November 13, 2013).

While US sales have exceeded expectations, the European uncertainty has been a brake on Biogen's market valuation. News of the decision sent shares up 13% to $285.62 on Friday, adding $8bn to the group’s market capitalisation. Today, analysts from Leerink Swann boosted their price target from $300 to $322.

The European panel also gave a lifeline to struggling Ariad when it outlined a series of recommendations for reducing the risk of cardiovascular events from its leukaemia treatment Iclusig, but did not suspend sales as the FDA has. Ariad shares shot up 35% to $3.78.

The HIV drug Tivicay, a single-agent integrase inhibitor product of the GlaxoSmithKline-Pfizer-Shionogi joint venture Viiv Healthcare, got the European panel’s backing, three months after US approval. And two hepatitis C drugs in a hot race to grab market share received regulatory blessing.

The EMA’s panel backed Gilead Sciences’ nucleoside NS5B polymerase inhibitor sofosbuvir, now called Sovaldi, as well as supporting a compassionate-use programme for its use with Bristol-Myers Squibb’s phase III NS5A inhibitor daclatasvir for patients at risk of liver failure or death within 12 months. Counterparts at the FDA in America, meanwhile, approved Johnson & Johnson and Medivir’s simeprevir, now called Olysio in the US and Sovriad in Japan.

Sweden-based Medivir shares were up 6% to SEK90.75 in mid-afternoon trading today, following the after- market announcement from the US regulator.

Bad news

Nevertheless, AB Science was unable to persuade the EMA to approve masitinib, now dubbed Masican, on the basis of phase II data in Gleevec-resistant GIST. The French group has planned to enrol 200 patients in a head- to-head phase III trial against Sutent in that second-line setting, so the story has not been fully told; it was not good news for investors, however, who saw shares fall 21% to €15 after Friday's announcement of the EMA vote.

Masican is also before the panel on similarly thin grounds as a result of a data dredge of its failed phase III pancreatic cancer trial (AB Science’s silence goes to the heart of masitinib’s approvability, January 28, 2013).

Another company that has struggled to get a win of late is Amarin, which saw its shares fall 12% to $1.76 on Friday after the FDA said it would not hear an appeal against its decision to rescind the special protocol assessment on the Anchor trial. The action has doused any hope of achieving approval of Amarin's fish-oil pill Vascepa in the mixed dyslipidaemia population before a larger outcomes trial reads out in 2016. To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @JonEPVantage on Twitter