Arena Investors Fight Back Against FDA
Arena Investors Fight Back Against FDA [The San Diego Union-Tribune]
From San Diego Union-Tribune (CA) (October 10, 2010)
Oct. 10--Frustrated by the reluctance of federal regulators to approve new prescription weight-loss drugs, a group of Arena Pharmaceuticals shareholders are waging a highly unusual campaign aimed at discrediting an unfavorable review of the San Diego company’s diet pill.
The investors, who lost millions of dollars when Arena’s stock price plummeted 76 percent in response to the review, have collected more than 1,700 signatures on a petition calling for the agency to approve lorcaserin by an Oct. 22 deadline.
They also have fired off letters to senior regulators, members of Congress and President Barack Obama attacking the credibility of some scientific arguments used by Food and Drug Administration staffers to raise doubts about the therapy’s safety.
"I think this is unprecedented," said Dr. Carl Peck, a former director of the FDA’s Center for Drug Research and Evaluation.
While company shareholders usually are disappointed when drug candidates run into regulatory trouble, they rarely -- if ever -- push back against the FDA with the kind of calculated offensive launched by the Arena group, said Kurt Karst, a Washington, D.C., attorney who represents pharmaceutical companies before the agency.
"It’s not usual to see investors go full throttle against the agency," he said.
Before the review, lorcaserin seemed headed for approval. Clinical trials turned up no serious side effects and the drug met the FDA’s requirement for a 5 percent weight loss in patients.
The Arena investors leading the campaign say members of an independent FDA advisory committee erred in their 9-5 vote against recommending approval of the treatment because they received a faulty, and perhaps biased, analysis from agency staffers of tumors that surfaced in laboratory rats taking doses 82 times higher than the prescription level.
Among their complaints, the investors argue that the staff analysis mistakenly combined benign and malignant breast tumor figures, resulting in an exaggerated view of the risk of cancer. They point out that the agency’s own guidelines say cancer in rats receiving drug doses above 25 times normal concentrations shouldn’t raise concerns in humans. They question why the matter surfaced as a significant issue in the committee review of lorcaserin months after FDA staffers approved large-scale tests of the drug on people despite the rat data.
The agency also should have placed a cancer specialist or a veterinary pathologist on the advisory committee, said the shareholders, who belong to an Internet-based investment club with 45 members spread across the country
All together, the group holds more than 2 million shares of Arena stock.
"What I want to see is fairness in this process," said Jim Stevens, a retired computer technology executive who lives in Carlsbad and owns 66,000 shares. "They should follow the science and bring in the right outside specialists to review the data so that Arena gets a fair hearing."
FDA officials say they are aware of the concerns.
"We are looking into them," spokeswoman Karen Riley said Friday.
In a briefing document given to the advisory committee before the panel’s Sept. 16 vote, FDA staffers raised concerns about the rat cancer data and the breast tumors in particular, writing "the relevance of these findings in rats to human risk cannot be dismissed." They expressed doubt about Arena’s theory that the malignancies were tied to the high drug doses given to the animals.
The FDA has been skittish of new weight loss drugs since the late 1990s, when it yanked the popular fen-phen treatment from the market because of cardiovascular problems. In more recent years, troubling side effects tied to a number of other chronic disease drugs have prompted the agency to adopted a more cautious approach when considering most new treatments.
On Friday, Abbott Laboratories pulled the Meridia diet pill off the U.S. market because of heart attack and stroke risks. The FDA had requested the move after a study linked the 13-year-old treatment to a 16 percent jump in cardiovascular side effects among high-risk patients who were followed for up to six years.
When crafting the petition and letters challenging the lorcaserin review, the investment club members turned to some of their own with pharmacological knowledge, including an emergency room physician near St. Petersburg, Fla., an internist who treats obese patients in Tucson, Ariz., and a major drug company worker in the Northeast.
"This isn’t just some orphan drug that will be given to 10 people," said Steven Vig, the Arizona physician. "This is a drug that will really improve the health of the nation. Obesity is a serious disease with serious consequences."
Arena officials, who have questioned the advisory committee vote, said they aren’t involved in the investor campaign.
"The company’s focus is on following the FDA’s review process to obtain approval of lorcaserin," company spokesman David Schull said.
If the drug makes it to market, it could become the first blockbuster medication to emerge from the San Diego biotechnology industry since 2005. Such success would deliver big profits to Arena and a handsome payoff to investors. The treatment also would help satisfy demand among overweight Americans and their doctors who have been waiting since 1999 for a new medication to fight obesity.
Arena faces competition from two other companies, Vivus of Mountain View and Orexigen of La Jolla.
Vivus’ experimental diet pill Qnexa was rejected by the FDA advisory committee in July because of concerns over side effects. A final decision by the agency is expected by Oct. 28.
Contrave, the drug made by Orexigen, will get an advisory committee review on Dec. 7.
It’s not clear whether the group’s campaign will have an effect.
"The FDA is in an extreme risk-averse mode" when considering new drugs, Peck said. "But this pendulum will swing back, and it may take something like this to get it back to some equilibrium."
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Posted: October 2010