July 1, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Swiss-based Roche and Hamburg, Germany-based Evotec AG announced yesterday that its Phase IIb clinical trial of Sembragiline in Alzheimer’s patients failed to meet its primary endpoint.
Sembragiline was licensed from Roche to Evotec in 2006 for a different indication. In 2011 the two companies inked an exclusive global agreement to develop and commercialize the monoamine oxidase type B (MAO-B) inhibitor for Alzheimer’s disease. Evotec received an upfront fee of $10 million with potential milestones up to $820 million and double-digit royalties on sales, which now seems very unlikely.
The study was a multicenter, randomized, double-blind parallel-group, placebo-controlled study dubbed MayflOwer RoAD. Patients with moderate Alzheimer’s either received Sembragiline or a placebo, as well as background therapy with one of the four other drugs approved for the treatment of AD, which includes donepezil, galantamine, rivastigmine or memantine.
Sembragiline did not demonstrate benefit on the primary endpoint, which was Alzheimer’s Disease Assessment Scale — Cognitive Behaviour Subscale, ADAS-cog-11, after 52 weeks of treatment. It proved to be safe and well tolerated.
“Clearly disappointing news that Sembragiline didn’t reach its primary endpoint, but Alzheimer’s is one of the biggest medical challenges of our times, and will remain a priority for Evotec and our partners,” said Werner Lanthaler, chief executive officer of Evotec in a statement. “Strategically, this program represents one out of more than 70 product opportunities within our portfolio in the fields of CNS and pain, metabolic diseases, oncology and anti-infectives.”
On Dec. 19, 2014, Roche announced it was discontinuing Scarlet RoAD, a Phase III study of gantenerumab on pre-dementia Alzheimer’s disease patients.
In July 2014, Roche announced that its drug crenezumab failed to meet its co-primary endpoints in Alzheimer’s patients. Those findings were not completely disappointing, because they did indicate a trend in cognition for individuals with mild disease who received a high dose of the drug intravenously.
On April 21, 2015, Massachusetts-based Biogen reported positive results from a Phase Ib clinical trial for aducanumab, which showed a significant reduction in amyloid plaque in patient’s with Alzheimer’s disease. Amyloid plaque is one of the substances found in the brains of AD patients that are linked to the disease.
Sembragiline is an MAO-B inhibitor. Other drugs currently on the market for AD in this category include generic selegiline and Azilect (rasagiline), marketed by Teva Pharmaceutical Industries Ltd. . In 2014 the Alzheimer’s Drug Discovery Foundation (ADDF) brought in $1.1 million in support of a clinical trial to evaluate rasagiline as a treatment for Alzheimer’s and Parkinson’s disease. The funding was provided to Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health.
Evotec stock took a slight dip on the news. Shares traded for $3.63 on Friday, June 26. They currently trade for $3.31 per share. The company stock has had its ups and downs this past year, with a low of $2.57 per share on Oct. 16, 2014 and a high of $4.06 on May 21. A year ago, on July 25, 2014, shares traded for $4.27.
Zacks upgraded from a “sell” to a “hold” rating in a research note today.
After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
Our most popular story last week was about a new wonder drug that wowed the FDA. An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible.
That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.
