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Arena Pharmaceuticals Gets a Preliminary OK

The FDA advisory committee’s recent thumbs-up vote for the anti-obesity drug lorcaserin has focused the national spotlight on the medication’s developer, Arena Pharmaceuticals Inc. as well as two other San Diego area companies that also hope to obtain FDA approval to market new weight-loss drug therapies.

“All the activity in San Diego to develop drugs to treat obesity is very exciting,” Dr. Sunil Bhoyrul, a bariatric surgeon as well as an attending surgeon at Scripps Memorial Hospital La Jolla, said.

Lorcaserin and the weight-loss drugs of Orexigen Therapeutics Inc., based in La Jolla, and Isis Pharmaceuticals Inc., in Carlsbad are not “magic bullets,” Bhoyrul, founder and director of Olde Del Mar Surgical in La Jolla, pointed out.

“They’re very promising drugs,” Bhoyrul added. “But, any obesity drug should be used in the context of an overall treatment program that also emphasizes dietary and lifestyle modification and counseling.” Such a comprehensive approach helps increase weight loss and reduce the chances that the patient will regain weight after stopping the drug, he noted.

At its recent meeting, the FDA advisory panel voted 18 to 4, with one abstention, that the available data showed that the potential benefits of lorcaserin outweigh the potential risks in the long-term treatment of overweight and obese individuals with high blood pressure, heart disease, diabetes or kidney disease.

“The advisory committee’s positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity,” Arena President and CEO Jack Lief said in a statement. “We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application.”

First Since Orlistat in 1999

The FDA, which is not bound to follow its advisory panel’s recommendation, is expected to announce its decision about lorcaserin by June 27. If approved by the FDA, lorcaserin will be the first new anti-obesity medication since orlistat was approved in 1999.

Orlistat is now available for prescription as Xenical and as the over-the-counter agent Alli. Because orlistat blocks the body’s absorption of fat, it can produce flatulence and loose bowel movements, side-effects that may help explain Xenical’s failure to achieve highly profitable blockbuster status for its developer, Roche USA.

Such side effects as flatulence are of much less interest to the FDA than are an obesity drug’s effects on heart functioning, according to industry experts. Indeed, because of the drugs’ cardiac side effects, the FDA has required the removal of several marketed weight-loss medications — Redux, for example, just two years after its approval in 1996. A drug’s side effects sometimes become evident after the medication has been approved and used by many more people than were studied in the clinical trials of the agent.

According to drug development experts, the lack of FDA approvals of new anti-obesity drugs during the past 13 years may reflect the agency’s caution about giving the go-ahead for the marketing and distribution of a medication that will be taken by a large population of people and that may have side effects that were not detected during clinical trials.

Huge Market

The market for anti-obesity drugs is substantial because one-third of adults and more than 17 percent of children and adolescents in the U.S. are obese, according to the Centers for Disease Control and Prevention. In addition, any new weight-loss drug may be over-prescribed — used by individuals who are not obese or even overweight but are simply weight-conscious. Thus, when such a large population of people is treated with a drug, the number of individuals who potentially could suffer side effects can be considerable, industry experts have pointed out.

FDA’s caution was shown during its review of Arena’s lorcaserin, which was developed in the company’s San Diego labs. Arena’s original new drug application to market lorcaserin was submitted to the FDA in December 2009. Almost one year later, the agency responded, indicating additional research data were required. Arena’s resubmission of an NDA in December resulted in the recent advisory panel vote.

Orexigen experienced FDA’s caution last year, when the agency required that the San Diego company conduct additional research to determine whether its product, Contrave, damages the heart. Orexigen’s new cardiovascular safety trial, which will involve 10,000 patients, will be in addition to the phase 3 clinical studies that the company already has submitted to FDA.

After lorcaserin, the next compound in line for possible FDA approval is Qnexa, developed by Vivus Inc., headquartered in Northern California. FDA is expected to announce its decision about Qnexa on July 17.

Isis Compound in Phase 1 Trials

ISIS-FGFR4, the anti-obesity compound developed by Carlsbad-based Isis Pharmaceuticals, is being evaluated in phase 1 clinical trials. Isis’ drug targets the liver and the body’s other fat storing tissues to boost the fat and calories burned by the body.

In contrast, lorcaserin and Contrave affect the brain’s biological mechanisms that influence appetite, satiety and food cravings.

Although San Diego-headquartered Amylin Pharmaceuticals Inc. does not have an anti-obesity drug in clinical studies, the company has a worldwide agreement with the Japan-based Takeda Pharmaceutical Co. Ltd. to co-develop and commercialize pharmaceutical products for treating obesity and related indications.

Amylin, however, has been investigating metreleptin, an analog of the so-called human “obesity” hormone leptin, to treat diabetes and/or high blood levels of triglycerides, a type of fat, in patients with rare life-threatening forms of the lipodystrophy disorder. Last month, Amylin completed and submitted its NDA to FDA.

Cathy Yarbrough is a freelance writer for the San Diego Business Journal.

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