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

Related Articles:
All eyes in the biotech world on Arena's diet pill
Arena shares up after FDA briefing on lorcaserin
Arena shares shine, briefly, as it presents its case for obesity drug
Arena maps out its one-year plan for lorcaserin

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

Eisai co-developing cancer drug fueled by bacteria; U.S. trials launch soon

Posted under Anaeropharma Science, bacteria, Blog, cancer treatments, Companies, Diagnostics, Eisai, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, stomach cancer, Universities, Videos by Mark Hollmer

Tokyo's Anaeropharma Science is launching U.S. clinical trials as early as March for a new stomach cancer drug fueled by bacteria. The biotech is partnering with Japanese drug giant Eisai to bring the treatment to market, according to the Daily Yomiuri. Testing will involve 60 patients over 3 ½ years. Anaeropharma loads the drug with bifidobacteria, which helps the drug both reach and build up within its tumor target because it is drawn to environments lacking oxygen, just like solid tumors. An anticancer agent taken by mouth then selectively targets those tumors after reacting to the drug, according to the article. Story

Preclinical study triggers ‘massive response’ from desperate Alzheimer’s patients

Posted under Blog, Companies, Diagnostics, Eisai, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

It's quite common on the R&D side of the business to see patients tracking the discovery work being done on their disease, particularly if they have an ailment that can't be effectively treated with any approved drug. Late last week, though, scientists found themselves in the spotlight after finding that an approved drug--Eisai's cancer therapy bexarotene--countered the impact of Alzheimer's in mice. And patients and their families were quick to besiege providers with requests to use the drug on an off-label basis.

"The Alzheimer's community is very desperate for anything that shows any sign of hope or promise," Eric Hall, CEO of the Alzheimer's Foundation of America, tells The Wall Street Journal.

"To patients and families who are this motivated, the idea of an off-label pill is not a major leap," neurologist Sam Gandy told the Journal. But it's also not necessarily a good idea to start taking a cancer drug for a completely unproven use. It's not at all uncommon for a mouse study to lead investigators down a blind alley, with no utility in humans. And in this case there's no solid idea of just what the prospective dosage should be, among other issues.

One of the scientists at the center of the media storm, Gary Landreth, says he's been the subject of a "massive response." He's starting a small study involving 12 subjects in a few weeks, but that's as far as the clinical plans extend for now.

The intense response underscores just how big a market awaits any drug developer that can begin to treat Alzheimer's. Ironically, though, neuroscience has become increasingly unpopular in the biopharma world, where the science is murky and patient outcomes hard to track.

- here's the story from The Wall Street Journal

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Mouse study triggers demands for a possible Alzheimer's treatment
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Eisai loses panel vote on new Dacogen use

Posted under Blog, Companies, Dacogen, Diagnostics, Eisai, FDA expert panels, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

A federal advisory panel voted down Eisai's attempt to gain an approval for Dacogen as a treatment for acute myeloid leukemia. The pharma company has been trying to gain an OK to use the drug for elderly patients for whom chemo has failed. The advisers voted 10 to 3 against, making any formal approval unlikely. Story