Diet Pill Maker Arena Pharmaceuticals (Nasdaq: ARNA) Wins Backing of FDA Advisers

Orlando, FL 5/11/12 (StreetBeat) -- In a stunning turn of events in less than two years, diet pill maker Arena Pharmaceuticals (Nasdaq: ARNA) won the backing of a panel of government advisers to sell what may be the first new weight-loss treatment in the US in more than a decade. The company’s shares rose 80% in early trading Friday after advisers voted 18-4 in favor of approving Arena’s drug, lorcaserin.

Arena is the second company to win such an endorsement for a diet drug this year after Vivus (Nasdaq: VVUS) was recommended by Food and Drug Administration advisers in February. The FDA delayed a decision on Vivus’ Qnexa, moving a potential approval date later than one set for Arena. If the FDA doesn’t adjust its dates, it will decide on Arena’s drug, lorcaserin, by June 27, and on Vivus’ Qnexa by July 17.

After a pair of overwhelmingly positive panel recommendations from advisers, it’s beginning to look like there may be two near-term approvals for diet drugs. That seemed unthinkable a little more than a year ago after Orexigen Therapeutics (Nasdaq: OREX) followed Arena and Vivus in being rejected by the US agency because of safety concerns.

Shares of Arena rose to $6.59 in morning trading. Vivus was up 4% to $23.57 and Orexigen, which is the farthest away from any potential approval, jumped 7% to $3.57.

Safety has been the killer for these new diet pills. The FDA is very cautious about approving another product that could pose health risks to people taking them. Abbott Laboratories (NYSE: ABT) withdrew its drug Meridia from the market in 2010 after fears of heart attack and stroke. The drug cocktail fen phen was withdrawn from the market in 1997 after evidence of heart valve damage. Those drugs were sold by American Home Products, which was later renamed Wyeth and is now part of Pfizer (NYSE: PFE).

In April, Vivus said the FDA was extending its deadline for an approval ruling on Qnexa because the agency needed more time to review a company plan on mitigating risks for patients. Arena, which is partnered with Japanese drug maker Eisai to sell lorcaserin, has responded to FDA worries about safety, including heart valve problems. However, Arena hasn’t yet discussed a risk plan -- a so-called a risk evaluation and mitigation strategy -- or a post-approval safety study with the FDA, company executives said on a conference call Friday. Eisai would pay 90% of any post-approval safety analysis. No decision has been made yet on a price for the pill.

Arena, Vivus and Orexigen argue that obesity is an epidemic in the US, leading to health problems such as heart disease, diabetes and other conditions.

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Orexigen® (Nasdaq: OREX) Announces FDA Agreement on a Special Protocol Assessment for the Contrave® Outcomes Trial

Palm Beach, FL 2/6/12 (StreetBeat) -- Orexigen®Therapeutics, Inc. (Nasdaq: OREX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Contrave® outcomes trial. On January 31, 2011, the Company received a Complete Response Letter to its New Drug Application (NDA) noting a single approval deficiency related to cardiovascular safety, requiring Orexigen to conduct a randomized, double-blind, placebo-controlled cardiovascular outcomes trial prior to approval. The objective of the trial is to demonstrate that Contrave does not unacceptably increase the risk of major adverse cardiovascular events (MACE). The Company plans to initiate the Contrave outcomes trial late in the second quarter of 2012.

"We are pleased to receive agreement on the SPA from the FDA after just one cycle of review," said Michael Narachi, President and CEO of Orexigen. "A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy. We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."

As previously outlined, approximately 10,000 patients will be enrolled in this streamlined trial which is focused on capturing infrequent MACE events. An interim analysis and NDA resubmission is planned once approximately 87 MACE events have occurred, which is anticipated to be less than two years from the start of the trial. If marketing approval is received for Contrave, the trial will continue toward the final analysis in the post-approval setting.

The Company plans to provide more details on the trial design and protocol on its fourth-quarter and year-end 2011 conference call in early March.

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