TeamAlzheimers.org - POTENTIAL NEW DRUG TO FIGHT ALZHEIMER"S

Medicine For Hay Fever May Treat Alzheimer's

By Michelle Fay Cortez

Doctors may learn next month that Dimebon, a 27-year-old hay fever treatment and one of the most mysterious compounds yet tried to fight dementia, is poised to become their newest and perhaps best weapon against Alzheimer's…

Medivation Inc., the start-up that persuaded Pfizer, the world's biggest drugmaker, to help develop Dimebon, may be ready to release new research data during the first week of March, said Bengt Winblad, head of Alzheimer's research at the Karolinska Institute in Stockholm and a leader of the European trials for the product. The study may confirm a 2008 finding in Russia that patients functioned better and thought more clearly after swallowing Dimebon tablets three times a day.

The data augur a make-or-break moment for San Francisco- based Medivation, which has no products on the market and has recorded losses exceeding $150 million since 2003. Pfizer, which hasn't brought a new drug to market that generates more than $1 billion a year since the pain pill Lyrica won U.S. clearance in 2004, has pinpointed Alzheimer's as one of six focuses of research. Doctors say millions of patients may benefit.

The 183-patient Russian study, reported in the Lancet in July 2008, "showed the most effective and sustained benefit that we've ever seen in Alzheimer's," said Samuel Gandy, associate director of the Alzheimer's disease Research Center at Mount Sinai School of Medicine in New York. "There is nothing that's currently approved that compares to it and nothing else really in the pipeline that compares to it."

Some patients were better after taking the drug for 18 months than they were at the start of the trial, something never previously seen with the progressive disease. Gandy, who wasn't involved in the research, said the drug stands to win approval even if the next study "is only half as good as the original."

Few Alzheimer's candidates beat the odds. There hasn't been a new drug for the disease since Namenda, from New York-based Forest Laboratories, was approved in 2003, and almost a dozen drugs in mid- to late-stage testing have failed since then, according to data compiled by Bloomberg.

Drugs that looked exciting in early studies have turned into disappointments, while others that appeared less promising ended up successful, said Constantine Lyketsos, chair of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore.

"Ultimately with Dimebon, the data will speak," Lyketsos said. "Even if it was hugely promising and exciting, it would be a little while before it ends up on the market. My patients and families need realistic hope at this point and I'm not sure that's realistic hope at this point."

Analysts said they expect Medivation and New York-based Pfizer to file for regulatory approval of Dimebon in 2011. Results from the 525-patient Connection study could move that date forward, company officials said.