Biogen Inc. BIIB announced data from a long-term study on its Alzheimer's disease (AD) candidate, aducanumab. Data from the study showed a continued benefit in the rate of amyloid decline over a two/three year period in patients with prodromal or mild Alzheimer’s disease when treated with aducanumab.
Shares were up 2.5% on Monday, in response to the promise shown by the anti-amyloid candidate.
The company said the results from a recently conducted analysis of the long-term extension (LTE) of its ongoing phase Ib study (PRIME) of aducanumab were consistent with the previously reported data from PRIME.
PRIME is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib study being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of aducanumab in patients suffering from prodromal or mild AD.
So far this year, Biogen’s shares have risen 3% while the industry recorded an increase of 7.2%.
Biogen is conducting two other phase III studies (ENGAGE and EMERGE) on aducanumab for the treatment of early AD. The results from LTE study support the design of ENGAGE and EMERGE studies.
Biogen is looking to strengthen its AD and other neurodegenerative disorders pipeline. Biogen’s AD pipeline comprises candidates with different mechanisms of action including anti-tau candidate (BIIB092/BMS-986168 – with potential in AD as well as progressive supranuclear palsy (PSP)), anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program.
However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging and we note that several companies have failed in developing treatments for the same. In November last year, Eli Lilly & Company's LLY anti-amyloid candidate solanezumab failed to meet the primary endpoint in a late-stage AD study. Lilly decided to drop the development of solanezumab. Lilly suffered a major setback in Aug 2010, when it had to halt the development of another phase III Alzheimer’s candidate semagacestat.
Meanwhile, Pfizer PFE shelved its late-stage Alzheimer’s candidate, bapineuzumab IV, after it failed two phase III studies. Pfizer was developing the candidate in collaboration with Johnson & Johnson JNJ and Elan Corporation.
The Alzheimer’s disease market represents a huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
Biogen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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