Biogen’s MS drug hits phase III targets
pharmafile | October 27, 2011 | News story | Sales and Marketing | BG-12, Biogen, MS
Biogen’s potential blockbuster MS drug BG-12 has met its primary endpoint in a late-stage trial.
BG-12 (dimethyl fumarate) tablets were being tested against placebo and against Teva’s injectable Copaxone.
In a second phase III study, BG-12 met its primary endpoint by significantly reducing relapses in patients with relapsing remitting MS by 44% versus placebo at two years.
The CONFIRM study’s comparator, Copaxone (glatiramer acetate), reduced relapse rates by just 29% compared with placebo at two years. Teva’s drug is currently the biggest selling MS drug globally, making the firm $3.3 billion last year.
But Copaxone could start to lose its grip on the market as new oral therapies – which are easier for patients to administer – start to become more widely available.
Doug Williams, Biogen’s executive VP of research and development, said: “We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients.
“We are gratified by these strong efficacy and safety results, which, when combined with BG-12’s oral route of administration, position it as a potentially important MS therapy.
“We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.”
Analysts are predicting peak annual sales of over $3 billion for the drug.
This could put it on a par with Novartis’ recently approved MS pill Gilenya, which is expected to be making peak annual sales of $2-$3 billion by 2015.
Eric Schmidt, an analyst with Cowen & Co. told Bloomberg: “The most important thing is safety, and the safety profile looks exceptional. This will position BG-12 as a front-line drug – it’s hard to imagine this won’t be a blockbuster.”
BG-12 is the only compound in clinical trials for the treatment of MS known to activate the Nrf2 pathway.
It is believed that the drug has the potential to reduce the activity and impact of inflammatory cells on the central nervous system and induce direct cytoprotective responses in CNS cells.
These effects may enhance the ability of cells to alleviate the inflammatory stress that plays a role in MS.
Ben Adams
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