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Biogen Idec plans phase III Alzheimer's trial before year-end

And MS drugs drive 2014 sales          
Biogen Idec building

Biogen Idec is working hard to catapult its Alzheimer's disease candidate BIIB037 into phase III trials, in the wake of "compelling" data reported last month, according to chief executive George Scangos.

A phase III trials programme for the drug will start "later this year," said Scangos during the company's fourth-quarter results briefing yesterday, with additional results from ongoing the 194-patient phase Ib trial due to be reported in March at the Alzheimer's & Parkinson's Diseases Congress  (AD/PD) in March.

That could mean that preliminary results will be available in 2016, although Biogen Idec's R&D head Doug Williams said discussions are still ongoing with regulators about the design of the pivotal trial.

BIIB037 - also known as aducanumab and originally developed by Swiss biotech Neurimmune - is an antibody targeting beta amyloid protein, which builds up in the brain in Alzheimer's patients and is thought to contribute to the neurodegenerative effects of the disease.

It was derived from antibodies taken from donors who were cognitively normal despite advanced age, on the hypothesis that these donors' immune systems had successfully resisted Alzheimer's disease. Early results from the phase Ib trial were encouraging and indicated a positive effect on cognition in patients with 'prodromal' or mild Alzheimer's.

Williams would like to use the same primary outcome measure in the phase III trial as in the ongoing study - the Clinical Dementia Rating (CDR) scale - on the basis this is more suitable for people with mild symptoms than the Adas-Cog scale generally used in Alzheimer's trials.

Biogen Idec has made a major play in Alzheimer's disease, licensing co-development rights last March to three other drugs - anti-amyloid antibody BAN2401, BACE inhibitor E2609 and a compound targeting tau protein - from Japan's Eisai. BAN3401 and E2609 are now entering phase II trials, said Scangos.

MS franchise drives sales

Biogen Idec reported a near-doubling in fourth-quarter profit to $884m on the back of strong sales of its multiple sclerosis (MS) franchise, although the roll-out of oral therapy Tecfidera (dimethyl fumarate) overseas hid a slowdown in the US market.

Overall, Tecfidera posted sales of $916m in the quarter, up from a little under $400m a year ago, which helped Biogen Idec's overall revenues grow by 34% to $2.6bn. For the full-year the drug made $2.9bn, a great performance in its second year on the market and more than offsetting declining sales of injectable MS therapy Avonex (interferon beta-1a).

Biogen Idec was also buoyed by a $40m contribution in the fourth-quarter from long-acting Avonex follow-up Plegridy (peginterferon beta-1a), and the company said expects Tecfidera growth to resume in the US and accelerate in Europe, where to date it is only available and reimbursed in a handful of markets including Germany, the UK, Italy and Spain.

Meanwhile, phase I studies are also ongoing for novel formulations of dimethyl fumarate, with the goal of achieving once-a-day dosing and potentially reducing side effects, said Scangos.


Article by
Phil Taylor

30th January 2015

From: Research



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