competition fat drug

I thought MBP might go down today as a reult of competition from the following.

Nearly 3-pound loss seen after a month
By Terri Somers
UNION-TRIBUNE STAFF WRITER

May 11, 2005

Without changing their eating habits or activity level, obese people taking Arena Pharmaceutical's experimental weight-loss pill dropped an average of nearly three pounds a month, the San Diego company is expected to report today.

Those taking the once-a-day, 15 mg pill lost four times more weight than people who were taking a placebo, the company said. The findings are the result of a 28-day, double-blind Phase 2 study involving 300 patients. "The results of the study are very supportive of further study and provide hope that obese individuals could have a new therapeutic option in the future to help control their weight in an effective, safe and controlled manner," said Dr. Steven Smith, the study's principal investigator.

The results are good news for Arena, which is just one of many companies in the international race to find a safe and effective diet pill for an increasingly obese population.

Drug industry experts predict that an effective weight-loss drug could generate more revenue than Lipitor, the best-selling cholesterol drug that had $12 billion in sales last year.

And given the effects of obesity and its cost to the nation's health care system, companies such as Arena expect that insurance companies will pay for the obesity drugs.

"Obesity is a serious health risk and is associated with several conditions, including diabetes, stroke and heart disease," said Smith, who is an associate professor at the Pennington Biomedical Research Center at Louisiana State University. "Patients and physicians need novel methods to treat obesity."

With the positive results in hand, Arena plans to start a second Phase 2 study – this one looking at the drug's safety and efficacy over three months, Arena chief executive Jack Leif said. If that is successful, the company would then seek to start a yearlong, final trial, he said.

Arena's drug, which has the working name APD356, targets a receptor in the brain's hypothalamus, triggering a feeling of being satiated, Leif said.

The triggering mechanism does not cause the body's metabolism to change, meaning that the body's rate of burning calories does not slow down to adjust to the person's decreased food consumption, Leif said.

The brain receptor, 5-HT2C, is the same receptor that was stimulated by the diet drug combination fen-phen that was popular in the 1990s, before it was found to cause cardiac problems.

But fen-phen hit a secondary target located in the heart, 5-HT2B, which caused the damage. Arena's drug does not hit that secondary target, Leif said.

"We designed our compound with 100-fold selectivity for the good receptor, and 100-fold less selectivity for the bad one," Leif said.

The study has shown no cardiac side effects in people who took the Arena drug, and no more symptoms of nausea, headache and cough than in those who took a sugar pill, Leif said.

The study participants weighed between 158 to 468 pounds, with an average body mass index of 36. About 80 percent of the study participants were women, and the average age was 40 years old. Participants were asked not to consume alcohol.

While there was a broad range of weight loss across the group of participants, the 2.9-pound average loss hit close to the gold standard of one pound a week that doctors recommend for patients losing weight, Leif said.

And patients continued to lose a steady amount of weight each week, rather than leveling off over time, Leif said.

Leif said Arena's drug will face two competitors on the market.

Abbott Laboratories makes Meridia, the brand name for sibutramine, which increases the level of serotonin in the brain and increases the feeling of satiety.

One of Meridia's side effects is hypertension. The drug's safety has been questioned by the advocacy group Public Citizen, which petitioned the Food and Drug Administration to remove the drug from the market.

Roche Pharmaceuticals makes Xenical, a lipase inhibitor, which blocks fat absorption. Xenical sales have been hampered by the drug's embarrassing side effects, including diarrhea, anal leakage and flatulence.

Arena's obesity drug and another for insomnia are the biotech's two lead products. Preliminary trial results for the insomnia drug are expected to be announced toward the end of the quarter, Leif said.

Arena has two other products with backing from large pharmaceutical companies.

Johnson & Johnson's Ortho-McNeil Pharmaceutical paid Arena an upfront fee of $17.5 million and an additional $4.8 million in research funding over two years for the development of drugs to treat type 2 diabetes.

The deal was unusual because Arena was able to negotiate a relatively high price for experimental compounds that are still in early laboratory testing.

Arena is also collaborating with Merck & Co. in the search for new cardiovascular drugs. Under that deal, Arena is eligible for up to $34 million in milestone payments and royalties from sales of any products that are commercialized.

In April, the company reported a loss of $25 million, or 79 cents per share, for the first quarter ended March 31, compared with a loss of $12.5 million, or 49 cents per share, in the same period last year.

At that time, the company had cash and short-term investments of $166.4 million.