obesity

Solvay shelves obesity drug

John Carroll — Mon, 17 Nov 2008 11:51:33 -0500

Solvay took a hard look at its experimental obesity drug and decided that the regulatory hurdles it faces are simply too high. The data for SLV319--in Phase II--"confirmed its clinical activity and its efficacy," according to the company. But the developer opted to shelve its work on the program nevertheless. Release | Report

Pfizer follows Sanofi lead, kills obesity program

John Carroll — Thu, 06 Nov 2008 09:49:38 -0500

Just hours after Sanofi-Aventis pulled the plug on its clinical trials for the diet drug Acomplia, Pfizer followed suit and called a halt on its development of an experimental weight loss drug belonging to the same class of drugs. Both drugs target the cannabinoid type 1, or CB1, receptors-the pleasure center in the brain that can be triggered by marijuana. The twin moves heralded the end of two programs for drugs that were once considered potential blockbusters.

"This will significantly affect the perception of their (future) revenues," but the companies could overcome that with replacement drugs down the road, analyst Steve Brozak of WBB Securities told the AP.

Acomplia was done in by its added risk of depression, anxiety and stress disorders. Pfizer said that "changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval" persuaded the company to end work on CP-945598, which was in Phase III trials.

"While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities," Martin Mackay, president of Pfizer Global Research and Development, said in a statement.

- see Pfizer's release
- check out the AP report

NeuroSearch touts Phase II tesofensine data

Maureen Martino — Fri, 24 Oct 2008 08:51:35 -0400

In a study published in The Lancet, Europe's NeuroSearch announced strong Phase II for tesofensine, the company's anti-obesity compound. The hunger-suppressing drug produced a weight loss twice that of currently approved obesity drugs Reductil/Meridia and Acomplia. "The results indicate that obese patients who typically obtain a weight loss of 3-5 kg with existing drugs on the market, can now expect a weight loss of 10 kg with tesofensine alone. If, in addition, the treatment is combined with the right diet, the total weight loss can amount to 20 kg," said Arne Astrup, one of the study's authors. NeuroSearch is planning to move the drug into Phase III trials.

- see NeuroSearch's release for more

ALSO: Bad news for Sanofi: The company has withdrawn Acomplia from the European markets following an EMEA recommendation that the company suspend sales of the drug due to safety concerns. Report

Merck dumps late-stage obesity drug

John Carroll — Thu, 02 Oct 2008 11:45:10 -0400

You can write off another experimental obesity drug. In a tersely worded statement, Merck announced that it is dumping its late-stage obesity drug taranabant after determining that the efficacy of the drug is tied to high doses--which in turn triggered side effects. The data for the drug demonstrated that researchers needed to use a 4 mg dose to get a 5 percent weight loss. But at 4 mg, the drug was also tied to twice the rate of psychiatric side effects. And Pharmalot notes that even at 2 mg the drug was "problematic," with twice as many patients dropping out of the trial at that dose compared to placebo.

"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Laboratories.

- see Merck's release
- read the story from Pharmalot

'Brown fat' may be a key to curing obesity

John Carroll — Tue, 26 Aug 2008 11:13:09 -0400

By manipulating levels of the protein BMP-7, Harvard Medical School researchers were able to generate a larger store of "brown" fat cells that burn calories--a pathway that could be used to pursue new therapies to fight obesity and a range of metabolic diseases. Mice injected with the protein reportedly developed more of the brown fat tissue and gained less weight. Obesity report

Developers advancing a new slate of weight loss drugs

John Carroll — Tue, 29 Jul 2008 12:11:15 -0400

The Wall Street Journal reviews the slate of mid-stage therapies in clinical trials for obesity. While the market for new therapies is huge, the challenges involved in developing a therapy that's safe, effective and free of embarrassing side effects have been vexing for the R&D crowd.

Among the most promising therapies in the pipeline: Novo Nordisk's liraglutide, which triggered weight loss of more than 5 percent in 75 percent of Phase II volunteers; Amylin Pharmaceuticals' combo of pramlintide and metreleptin, which triggered an average weight loss of 12.7 percent in 177 Phase II volunteers; and Arena Pharmaceuticals' lorcaserin, which is going into Phase III.

- read the article from the Wall Street Journal

Biotechs discuss obesity therapies at BIO

Maureen Martino — Fri, 20 Jun 2008 12:30:04 -0400

No fewer than 20 drug companies are working to find a drug to treat obesity. About $30 billion is spent each year on weight loss products, but only $200 million of that is spent on prescription drugs. At the BIO conference, Amylin Pharmaceuticals, Arena Pharmaceuticals and Orexigen Therapeutics representatives discussed the challenges of creating a drug to fight fat.

"I'm delighted that we are having this panel discussion, because if you look at a number of therapeutic areas, obesity stands out as one of the highest unmet medical needs, specifically with its link to hypertension, diabetes and a number of other diseases," said Christian Weyer, executive director of clinical research at Amylin. The challenge is that while losing weight is not that difficult, the human body has evolved in a way that makes keeping it off difficult--as anyone who has ever tried a diet knows. With 80 million obese people in the U.S. alone, the potential market for such a drug is huge--if developers can overcome the challenges.

- read this report for more

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

Arena touts safety profile of obesity drug

Mon, 17 Mar 2008 07:59:58 -0400

The analysts were buzzing this morning about Arena Pharmaceuticals' chances of a major partnership pact for its obesity drug lorcaserin after hearing that a review of the late-stage drug demonstrated no heart safety issues after 12 months of use. That's been a key issue for Arena, whose drug looks much like the Wyeth obesity therapy that was pulled after demonstrating heart valve risks. Efficacy data from the Phase III trial remains blinded until the trial is completed.

"We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present," said Arena CEO Jack Lief in a statement.

"The 12-month data substantially de-risks the lorcaserin development program and should place (Arena) in a stronger position to negotiate a major commercialization partnership for the drug," writes Oppenheimer analyst Bret Holley.

- see the release
- read the report from Dow Jones

Related Articles:
Arena Pharmaceuticals prices $109M public offering. Report
Arena prepares pivotal trial on obesity drug. Report
Arena reports successful lorcaserin trial. Report

Merck inks diabetes deal with fledgling Marcadia

Fri, 07 Mar 2008 06:59:57 -0500

Fledgling developer Marcadia Biotech has lined itself up with the pharmaceutical giant Merck in a licensing deal on the Indianapolis-based developer's work in diabetes. Marcadia has been working with the research of Dr. Richard DiMarchi, who moved to Indiana University's chemistry department after working at Eli Lilly. Merck has gained rights to some of Marcadia's drug candidates and is putting up an unspecified amount of money for collaborative research and milestone payments.

"Marcadia has generated a unique collection of peptide drug candidates with potentially novel therapeutic attributes," said Merck's Senior Vice President Luciano Rossetti M.D. "This latest collaboration underscores our strategy to establish a robust early-stage pipeline that delivers superior diabetes and obesity therapies."

- here's the press release
- read the report from the Indianapolis Business Journal

Related Article:
Fortune scolds Merck for "risky" programs. Report

ALSO NOTED: Promacta gets priority review; GTx drug hits endpoint; Alexza touts IIa data; and much more...

Mon, 03 Mar 2008 06:59:50 -0500

> Glaxo's Promacta, a bleeding disorder drug, will be given a priority review by the FDA. Release

> GTx announced that an 80 mg dose of toremifene citrate experienced reduced rates of hot flashes in prostate cancer patients on ADT therapy, hitting a secondary endpoint in a late-stage trial. Report

> Alexza Pharmaceuticals announced that its Phase IIa trial for its migraine drug AZ-104 hits its primary endpoint of two-hour pain relief after two doses compared to placebo. Report

> Denmark's Neurosearch reported positive data for its obesity drug. "Neurosearch considers the TIPO-2 results highly supportive for the continued development of Tesofensine both in terms of superior efficacy and safety." Release

> Valeant Pharmaceuticals has sold its Asian operations to Invida Pharmaceutical for $37.8 million. Release

> AEterna Zentaris and Paladin Labs have inked a sales deal on all rights related to miltefosine for Cdn$9.125 million in cash. Release

> A hedge fund has cut its holdings in CV Therapeutics to 2.1 percent. Report

> Put your cards on the table, ladies and gentlemen. A U.K. minister is calling on drug companies to hand over all their data on antidepressants to the National Institute for Health and Clinical Excellence. Report

> Want to know what happens inside a pharma company during a recall crisis? Check out Sunday's Chicago Tribune, which details the behind-the-scenes scramble at Baxter. Report

> Celebs may help sell magazines but do they really help market drugs? In the wake of Robert Jarvik's public downfall from Pfizer's pitchman-pedestal, advertising experts are wondering. Report

And Finally... Narcoleptics experience a high rate of eating disorders, with binge eating and food craving at the top of the list. Release

ALSO NOTED: U.K. calls for halt to HIV study; Cadence to raise $49.3M; and much more...

Fri, 15 Feb 2008 06:59:50 -0500

> The U.K.'s Medical Research Council has advised Indevus Pharmaceuticals to close the high-dose arm of it's Phase III HIV study. Release

> Cadence Pharmaceuticals is raising $49.3 million in a registered direct common stock offering. Release

> The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. Report

> Well, we didn't have to watch Alex Gorsky for long. According to the Wall Street Journal, when Novartis said that the U.S. pharma CEO was leaving, they left out the part about his returning to alma mater Johnson & Johnson. Report

> The FDA has approved a label change adding depression as a possible side effect of the cholesterol meds Vytorin and Zetia. Report

> Sanofi Pasteur has submitted the first vaccine delivered by an intradermal microinjection system for European approval. Report

> Despite spending a dramatically higher amount than before on treatments for spinal pain, Americans aren't getting great results, according to a new study. Report

> FierceHealthcare asks: Would a new agency curb pharma marketing misdeeds? Editorial

And Finally... Natural purple pigments found in fruits, vegetables and berries may help prevent obesity. Release

FDA overhauls trial design with new suicide standard

Thu, 24 Jan 2008 06:59:58 -0500

The FDA has quietly engineered the biggest change-up in the way many clinical trials are designed since the early '90s. Developers working in a range of fields including obesity, epilepsy, smoking cessation, depression and more are being required to investigate the added risk of suicide. Merck, Sanofi-Aventis and Eli Lilly are all adding suicide assessments to trials, as the FDA notifies developers of the new trial standard.

The new requirement has been in the works for several years, starting with startling indications four years ago that antidepressants increased suicide risks among children and teenagers. The New York Times adds that fresh alarm bells were rung by Acomplia, an obesity drug from Sanofi-Aventis also linked to psychiatric side effects.

- read the report from The New York Times

FDA committee rejects Solvay's tedisamil

Thu, 13 Dec 2007 06:59:55 -0500

An FDA expert panel has unanimously turned thumbs down on Solvay's tedisamil for atrial fibrillation. The experts said they would need more and better data before they could change their decision. Solvay says it will continue to work with regulators. The key problem, says the panel, is that the trial data indicates only a narrow dosage range that could be safe and effective. Serious side effects were noted for the high dosage and lower doses were less effective in treating the condition.

"It's almost like throwing a dart (to determine) what the dose should be," Tom Marciniak, medical team leader at FDA's cardiovascular and renal unit, told the advisory panel. "What will really happen to this drug when it's put out into the real world?"

- check out this release
- read the AFX report for more

ALSO: Solvay revealed a new family of biomaterials. Report

Related Articles:
Wyeth, Solvay handed FDA rejection. Report
Solvay earns $25M as obesity drug advances. Report

Merck presents pipeline update to analysts

Wed, 12 Dec 2007 06:59:58 -0500

At a meeting with investors yesterday, Merck highlighted several of its late-stage pipeline hopes. One of the most-watched drug candidates in Merck pipeline, of course, is anacetrapib--a drug in the same class as Pfizer's failed torcetrapib. Investors are waiting to see whether the potential blockbuster can succeed where Pfizer's drug failed. Merck officials assured analysts that torcetrapib's flame-out wasn't indicative of problems with the entire class of CETP inhibitors. Phase III trials of anacetrapib are planned for 2008.

Among other pipeline hopes is Merck's obesity drug taranabant, which is in Phase III and could be up for FDA approval in 2008. Taranabant is in the same class of drugs as Sanofi-Aventis' Acomplia, which has thus far failed to gain approval in the U.S. Merck is expecting an FDA decision on NDAs for Emend for Injection and Cordaptive, a cholesterol drug that combines a known ingredient with a new one that reduces the risk of flushing. Also in 2008, Merck anticipates filing an NDA for MK-0524B, simvastatin combined with laropiprant and extended-release niacin.

- see this release from Merck
- see the company's update on its pipeline

ALSO: Get more on Merck's Phase III candidates. Report

PLUS: In reviewing Merck's application to convert Mevacor to over-the-counter, FDA staff said it wasn't clear whether consumers could use the statin safely and effectively. But the agency didn't say consumers clearly couldn't, either. Report

Related Articles:
Merck's CETP program advances--with caution. Report
Torcetrapib disaster unlikely to sink other CETP inhibitors. Report
Merck cautiously upbeat on cholesterol drug. Report

Nastech spins off RNAi unit, restructures

Wed, 14 Nov 2007 06:59:56 -0500

After a rough week that saw its stock price slide by 65 percent following Proctor & Gamble's decision to bolt from a collaboration deal, Nastech Pharmaceutical is laying off workers and restructuring its operations. For now, there's no estimate on exactly how many of Nastech's 197 workers face pink slips. But Nastech wants to concentrate its focus on late-stage therapies--including the osteoporosis product once partnered with P&G.

Nastech's RNAi business is also being spun off into a separate, publicly traded biotech. A spokesman for the company told the Seattle Post-Intelligencer they were already planning the spin-off. This is the second big partner to bolt from a pact with Nastech. Last year Merck dropped out of a pact with Nastech involving an obesity therapy.

- see this release on the cuts
- read the release on the RNA spin-off
- check out the report from The Seattle Post-Intelligencer

Related Articles:
Nastech shares wilt after P&G returns drug rights. Report
Nastech to push ahead with obesity spray trial. Report
Nastech hit on missed payment. Report

Arena Pharmaceuticals prices $109M public offering

Fri, 02 Nov 2007 07:59:56 -0400

Arena Pharmaceuticals has announced the pricing of its public offering of 11,000,000 shares of its common stock at a public offering price of $9.91 per share. All of the shares are being offered by Arena. The CIBC World Markets and UBS Investment Bank are acting as joint book-running managers. In late September, Arena announced positive preliminary results from its Phase 2 clinical trial of APD125 in patients with chronic insomnia. Its lead drug is lorcaserin hydrochloride, which is in a pivotal late-stage study for the treatment of obesity. The compound stimulates the 5-HT2C serotonin receptor, located in the hypothalamus, an area of the brain associated with the control of satiety and metabolism.

- check out Arena's release
- see this article for more

Related Articles:
Arena Pharma produces positive insomnia data. Report
Arena prepares pivotal trial on obesity drug. Report
Arena reports successful lorcaserin trial. Report
The Biotech Haunted House. Report

Palatin slashes staff following FDA objections

Wed, 26 Sep 2007 06:59:56 -0400

With its lead therapy raising some serious safety concerns at the FDA, Palatin Technologies announced that it is whacking about a third of its workforce. The move, which comes just two weeks after King Pharmaceuticals dropped out of its partnership with Palatin, will leave Cranbury, NJ-based Palatin with a workforce of 64 and is designed to save about $4 million in costs. Palatin has run into a roadblock with the development of bremelanotide. Regulators have questioned the drug's safety, noting a rise in blood pressure among volunteers taking the therapy. Palatin says it will continue on with a collaboration with AstraZeneca on obesity therapies as well as further developing a candidate for treating congestive heart failure.

- see the release on the cutbacks

Related Articles:
King bails on Palatin's FSM program. Report
Palatin researchers tout data. Report
Safety concerns force delay for Phase III ED trial. Report

Sanofi underscores pipeline advances, setbacks

Mon, 17 Sep 2007 06:59:55 -0400

Sanofi-Aventis had some good news and some bad news to deliver to analysts during its first pipeline update in two years. On the down side: Its Alzheimer's drug Xaliproden failed late-stage trials. But its antidepressant saredutant passed its late-stage trials, setting up a schedule to file for approval in Europe and the U.S. next year. Another antidepressant, Amibegron, met its primary goal in only one out of four clinical trials.

Sanofi research chief Marc Cluzel (photo) underscored his commitment to the obesity drug Acomplia, though he acknowledged that the drug now faces a long delay in the U.S. Sanofi also announced that it has 48 therapies in late-stage development and expects to file on 31 of them by the end of 2010.

- see Sanofi's release on the pipeline
- read the AP report from Paris

Related Articles:
What's Warren Buffett buying now? Report
Sanofi shares plunge on Acomplia rejection. Report
Sanofi shares slide as FDA delays Acomplia-again. Report
Sanofi signs stem cell pact in China. Report

NeuroSearch investors thrill to trial data

Mon, 17 Sep 2007 06:59:54 -0400

Shares of NeuroSearch surged on the news that its obesity drug tesofensine produced very good data in a Phase IIb trial. The drug hit all endpoints with a high statistical significance. One analyst dubbed the data "fantastic," which did no harm to the stock value.

- see NeuroSearch's release on the results