TeamAlzheimers.org - DISAPPOINTING NEWS FOR TREATING ALZHEIMER'S

Pfizer, Medivation’s Drug
Fails in Alzheimer’s Study

By Michelle Fay Cortez

Pfizer Inc. and Medivation Inc. said their experimental Dimebon drug for Alzheimer’s disease failed to benefit patients in an advanced study, sending Medivation shares plunging.

The results of the 600-person trial counter an earlier study in Russia that found improvement in patients getting Dimebon. Medivation, which has no marketed products, dropped 67 percent in Nasdaq trading. Development of the drug may be halted, said Raghuram Selvaraju, head of health-care research at Hapoalim Securities USA Inc., in New York…

The negative outcome of the study is the latest setback in efforts to find a way to slow the most-common form of dementia in elderly people. Dimebon, a 27-year-old hay fever treatment, could have generated more than $5 billion in annual sales if proved effective, Selvaraju said.

“We are surprised and disappointed,” said David Hung, chief executive officer of San Francisco-based Medivation, in a telephone interview. “We’re trying to figure out what happened in the study and decide how to move forward. This is obviously one battle in our war against Alzheimer’s disease.”

Alzheimer’s is a progressive disease that starts with mild forgetfulness and eventually robs patients of memories and independence. It afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International, an advocacy group based in London. Existing drugs temporarily ease symptoms; none cure the disease.

Medivation declined $27.15 to $13.10 at 4 p.m. New York time on the Nasdaq Stock Market. Before today, the stock had risen 6.9 percent this year, giving the company a market value of $1.35 billion. New York-based Pfizer declined 28 cents to $17.32 in New York Stock Exchange composite trading.

Pfizer, the world’s biggest drugmaker, will decide whether and how it plans to continue developing Dimebon after it has fully evaluated the study results, said Briggs Morrison, senior vice president of the company’s primary-care development group, in a telephone interview.

“We’re deep in that phase of digging through the data,” Morrison said. “After that review, Pfizer will be in a position to determine appropriate next steps regarding the Dimebon program.”

Pfizer is likely to return its Dimebon rights to Medivation, Selvaraju said in a note to investors.

Because of “the uninspiring results,” he wrote, “we expect Medivation and Pfizer to halt development of Dimebon in Alzheimer’s disease.”

The trial, dubbed Connection, included patients with mild to moderate Alzheimer’s from the U.S., Europe and South America.

Patients on Dimebon didn’t do better than those given placebo in mental functioning after six months, the main goals of the study. It also failed to show benefits on the study’s secondary objectives, which looked at behavior, mental function and patients’ ability to care for themselves.

“We think this was nearly the worst-case scenario, although management will talk about other ‘shots on goal,’” said Michael Yee, an analyst at RBC Capital Markets in San Francisco, in a note to investors today. He rates Medivation stock “sector perform.”

The U.S. Food and Drug Administration told the companies that the original Russian study, published in the journal Lancet, would be considered a pivotal trial. Most regulators require positive results from two pivotal trials, typically in the third and final stage of human testing, to win approval.

Selvaraju, who considers himself one of the most optimistic analysts on Dimebon, predicted a 40 percent chance of success for the drug before the results were released.

There are four other Dimebon studies under way, evaluating the drug in addition to standard treatment in patients with mild-to-moderate and moderate-to-severe disease, Hung said. The company also is testing it in Huntington’s disease, a degenerative neurological disorder that runs in families.

Existing drugs for Alzheimer’s including Aricept from Pfizer and Tokyo-based Eisai Co., the leading therapy with $2.5 billion a year in annual sales, temporarily ease symptoms of Alzheimer’s disease. Doctors and patients are looking for novel treatments that slow the progression of the illness, allowing patients to remain in their homes and take care of themselves for longer periods of time.

There hasn’t been a new drug for Alzheimer’s disease since Namenda, from New York-based Forest Laboratories Inc., was approved in 2003. Almost a dozen drugs in mid- to late-stage testing have failed since then, according to data compiled by Bloomberg.

“Developing treatments for Alzheimer’s disease is a tough business,” said Michael Krensavage, founder of Krensavage Asset Management in New York. “The landscape of Alzheimer’s research is littered with failure. The drugs that are available provide little clinical benefit.”

Researchers have announced setbacks with experimental treatments from GlaxoSmithKline Plc, AstraZeneca Plc, Martek Biosciences Corp., Johnson & Johnson, Abbott Laboratories and Myriad Genetics Inc. in the past year.

One of the most eagerly anticipated drugs, bapineuzumab from Pfizer and New Brunswick, New Jersey-based Johnson & Johnson, reduced the buildup of amyloid plaque in the brains of patients with Alzheimer’s disease, according to a study published March 1. Patients getting the drug in the trial didn’t show a clear improvement in mental function.

Medivation 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.

Medivation also has a prostate cancer drug in development with Japan’s Astellas Pharma Inc. Information on that treatment won’t be available until the second half of 2011, according to RBC’s Yee.

Pfizer has eight other compounds in development for Alzheimer’s disease.

“We are committed to this area,” Pfizer’s Morrison said. “We know it’s going to be hard and we know there’s going to occasionally be disappointments like this one. But that doesn’t in any way change our commitment to trying to come up with important treatments for Alzheimer’s disease patients.”

To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net