UPDATED: Arena Pharma’s weight drug wins the day, shares soar

Posted under Arena Pharmaceuticals, Blog, Companies, Diagnostics, Eisai, FDA, Funding, lorcaserin, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos, weight drugs by rmcbride

Arena Pharmaceuticals' closely watched diet pill won over FDA advisers today. A committee of non-agency advisers backed approval of the weight drug, lorcaserin, which went down in flames when last in front of the same panel in 2010.

The turnaround for the program marks a victory for San Diego-based Arena ($ARNA) and its partner for U.S. marketing, Eisai. The FDA will consider the panel's 18-4 vote in favor of approval in the agency's decision on whether to green-light the drug. As Bloomberg notes, the agency hasn't approved a weight loss drug in 13 years. Vivus ($VVUS) and Orexigen ($OREX) are also in the hunt to advance new drugs to combat obesity, which affects more than a third of the U.S. population.

The FDA has taken a tough stance on the safety of obesity meds, and Arena's lorcaserin has been no exception. Arena faced numerous questions about potential side effects of the drug such as malignancies, heart valve damage and psychological problems. And critics of the program point out the modest efficacy data on the drug. Yet the company made a compelling enough case during Thursday's advisory committee session in Silver Spring, MD, to come away with a win.

After the panel meeting closed, shares of Arena skyrocketed. The stock more than doubled at points early in the morning and traded at $7.16, up from the May 9 close of $3.66 as of 8:55 a.m. ET.

Yet worries linger about the effects of the drug on the heart. An FDA briefing and panel members were satisfied with data Arena provided to show that the risk of cancer to patients who take lorcaserin appears remote. However, there was less certainty about the long-term impact of the drug on patients' hearts, Bloomberg reported. And any unresolved safety issues threaten the timely approval of the drug.  

"We expect lorcaserin to be approved; now the question is when," J.P. Morgan analyst Cory Kasimov said in a note to investors this morning. "It's now certainly feasible that the drug is approved at that time. However, a number of panelists mentioned their desire for a Risk Evaluation and Mitigation Strategy and a post-approval [cardiovascular] outcomes trial."

The FDA has set an action date of June 27 for its decision on approval of lorcaserin.

- see Bloomberg's article
- here's more from Reuters
- read the AP story on CBS

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Editor's note: Story is updated with analyst insights and additional details from the FDA panel on Thursday.

All eyes in the biotech world on Arena’s diet pill

Posted under Arena Pharmaceuticals, Blog, Companies, Diagnostics, Drug Safety, FDA, Funding, lorcaserin, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos by rmcbride

Today belongs to Arena Pharmaceuticals' ($ARNA) experimental weight drug. Biotech industry watchers are paying close attention to an FDA advisory committee today that will judge the biotech's drug, lorcaserin, a contender in the race to break a long dry spell in U.S. approvals for diet pills. Trading for the stock has been halted.

The advisory committee session has been one of the most highly anticipated events of the week in the biotech world, with the FDA expected to factor in the panel's vote in the agency's decision on approval. Biopharma commentator Adam Feuerstein from The Street has been blogging live from panel venue this morning, noting that the much-anticipated vote on whether the non-agency experts will endorse the weight drug is likely to happen later this afternoon.

Safety concerns have plagued Arena's and others' past tries to gain approval of new anti-obesity remedies, and the risks of lorcaserin are expected to weigh most in the advisers' votes on whether to recommend the treatment for approval. FDA staff harped on the potential risks of malignancies and heart problems developing in patients on the drug, in a briefing released on Tuesday. And they brought up concerns about the impact of lorcaserin on the 5HT2 receptor in the brain that is nonspecifically targeted with the banned fen-fen weight drugs, which were pulled off the market more than a decade ago after patients on the drugs suffered heart valve damage.

In one post this morning, Feuerstein wrote that an FDA official said Arena's data on 5HT2 receptor activity was sufficient to settle the receptor selectivity issue. Heart valve risks are a chief concern of regulators, and the advisory committee recently recommended that all new diet drugs undergo cardiovascular risk studies even when there is no evidence of heart problems in clinical trials.

Stay tuned for updates on the outcome of the FDA panel later this afternoon.  

- here's a link to Feuerstein's live blog

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UPDATED: Arena shares up after FDA briefing on lorcaserin

Posted under Arena Pharmaceuticals, Blog, Companies, Diagnostics, FDA, Funding, lorcaserin, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Pipeline, Startups, Universities, Videos, weight drugs by rmcbride

Arena Pharmaceuticals' ($ARNA) stock jumped this morning after the market got wind of FDA briefing documents that drilled into the risks and benefits of the company's highly watched weight-drug lorcaserin. The agency is urging its advisers to probe the heart and tumor risks associated with the drug at a panel slated for Thursday, yet the briefing document released this morning didn't appear to raise any new red flags that would prevent the committee from backing approval of the experimental treatment.

San Diego-based Arena's stock was up 14.34% to $3.11 per share as of 11:59 a.m. ET as investors bet on the likelihood of a positive panel review.

The company is in the three-way race to get U.S. approval for the first anti-obesity treatment in more than a decade, during which time the obesity rate in America has trended upward. The dry spell in weight-drug approvals underscores the FDA's conservative approach to weighing the risks versus the benefits of the treatments, and unanswered questions about the potential risks of Arena's lorcaserin prompted regulators to issue a complete response on the company's previous application in 2010. 

Safety issues will be discussed thoroughly during this week's panel. The FDA advisers will consider data on rats treated with lorcaserin to judge the risk of tumors associated with the drug, as well as evidence related to risk of heart valve damage from treatment. Lorcaserin is designed to act a receptor in the brain to impact appetite, and other drugs that impact the same receptor nonspecifically--fenfluramine and dexfenfluramine, the infamous fen-fen treatments--have been linked to heart value damage and were pulled from the market more than a decade ago, according to the FDA.

Reviewers are also probing the psychiatric side effects of lorcaserin. Psychiatric disorders were relatively rare in Arena's Phase III studies of the drug but were seen in more patients on lorcaserin than those taking a placebo.

Oddsmakers are watching the FDA advisory committee that will consider lorcaserin this week very closely. The same group recently backed a plan to require assessments of heart safety risks of new weight drugs even when clinical trials don't indicate that such dangers exist, Reuters reported. And J.P. Morgan analyst Cory Kasimov said in a note this morning that four of the 9 voting members of this week's panel were part of the group that rejected Arena's bid for approval in 2010, with three out of the those four returning having voted against giving Arena a nod to sell the drug.

- get the FDA briefing docs here
- see Reuters' article

Related Articles:
Arena shares shine, briefly, as it presents its case for obesity drug
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Arena maps out its one-year plan for lorcaserin

Editor's Note: Updated stock price in article at 11:59 a.m. ET on 5/8/12.

Vivus shares slide as FDA delays decision on Qnexa

Posted under Arena Pharmaceuticals, Blog, Companies, Diagnostics, Funding, lorcaserin, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Qnexa, Regulatory, Startups, Universities, Videos, Vivus by john

Shares of Vivus slid more than 6% after the news spread that the FDA would delay a final decision on its closely watched application for the weight drug Qnexa. And in a matter of minutes analysts began to handicap the company's ($VVUS) chances, with several concluding that the delay came with a tantalizing clue about its prospects.

The word from regulators was simple enough. They want the extra time to evaluate Vivus' risk evaluation plan for the drug, one of three still angling for a regulatory win after getting stiff-armed at the FDA. Vivus' chances, though, were increased dramatically in February after a majority of the FDA's expert panel concluded that Qnexa warranted an approval, based on its risks and rewards.

Looking over the Twitter feed, it was clear that there were some who felt the added time positioned Arena's ($ARNA) lorcaserin for a first approval. Others scoffed at the idea. And Cowen's Simos Simeonidis insisted in a note to investors that an OK for Qnexa may already be a done deal.

"Given what happened at the Qnexa panel, we believe the FDA has probably already decided that it will approve Qnexa," observed Simeonidis, "so we don't see any negative read-through from this delay."

After all, wrote TheStreet's Adam Feuerstein, if the FDA had decided to hand out a complete response letter on Qnexa, it would have moved on April 17. A delay has to indicate a likely approval.

We'll find out who's right by the new action date: July 17.

- here's the Reuters story
- read the report from TheStreet

Related Articles:
Arena shares shine, briefly, as it presents its case for obesity drug
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Now, Vivus has to gear up for probable Qnexa launch