Plavix

BMS inks $227M collaboration deal with KAI

Tue, 13 May 2008 06:59:55 -0400

South San Francisco-based KAI Pharmaceuticals is getting a $25 million boost from Bristol-Myers Squibb---its upfront payment for a collaboration on KAI-9803, an experimental therapy to reduce the severity of a heart attack and improve clinical outcomes. BMS will also buy $10 million in KAI equity and up to $192 million in milestone payments and will pay for all future development efforts, including an upcoming Phase IIb. KAI also retains co-promotion rights in the U.S.

"This is a major milestone for KAI-9803, our most advanced of three clinical programs, and a strategically important collaboration for KAI," says CEO Steven James. "Bristol-Myers Squibb is a great partner for us with its impressive history of developing and commercializing breakthrough medicines in cardiovascular disease. We believe this deal is testimony to the value and potential of KAI-9803 and our broad proprietary technology around protein kinase C modulation." KAI was a 2006 Fierce 15 company.

- check out the press release
- read the Dow Jones report

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

Fri, 09 May 2008 06:59:50 -0400

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Medical Association to join the fray. DTC report

> U.S. lawmakers aren't the only ones toughening up on pharma promos. In the U.K., the industry itself is strengthening its code. Report

> Sanofi-Aventis and Bristol-Myers Squibb may have squashed copycat Plavix in the U.S., but competition is now popping up in Europe. Plavix report

> We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. Public Citizen is now campaigning to have the patch taken off the market completely. Ortho-Evra report

> Researchers are touting the early results from a study of a new brain cancer vaccine that combines protein antigens extracted from a patient's tumor and matches them with white cells also drawn from the patient. Vaccine report

And Finally... The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. Report

Lilly's prasrugel stands out in comparison study

Mon, 31 Mar 2008 07:59:57 -0400

Here's one other reason for Lilly to be upbeat today. In a head-to-head study, the new antiplatelet drug prasugrel (being developed by Lilly and Daiichi Sankyo) in combination with aspirin outperformed the standard therapy, clopidogrel (Plavix) with aspirin. Analyzing the data from 12,844 patients in clinical trials, researchers concluded that the prasugrel group suffered fewer ischemic events--including stent thrombosis--than the Plavix group. Patients who have been given a stent to open up the flow of blood are at risk of blood clots, or stent thrombosis. They're given doses of antiplatelet drugs to prevent the clots from occurring.

"These data highlight the importance of aggressive antiplatelet therapy to reduce ischemic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention," the study authors concluded. "When balancing risks and benefits of strategies to prevent ischemic events, consideration should be given to patient characteristics, including risk of bleeding and ischemic events as well as stent and procedural characteristics."

- check out the release
- read the story in the Washington Post

Relate Articles:
Investors fret over Lilly's pipeline, Prasugel data. Report
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Prasugrel gets priority review

Fri, 22 Feb 2008 06:59:56 -0500

The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. The NDA for prasugrel was submitted to the agency in December. Now the drugmakers can expect an FDA ruling in just six months, rather than the 10 months is usually takes for a drug to receive approval. Lilly has a lot riding on prasugrel's approval, as many industry watchers say the company has no other blockbuster hopefuls in its pipeline. Both companies' shares rose on the news.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

- see this release
- check out the Wall Street Journal article for more

Lilly submits prasugrel NDA

Fri, 04 Jan 2008 06:59:58 -0500

Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. In a recent study prasugrel was more efficient than Plavix at reducing the number of heart attacks and other significant events. However, an increased number of bleeding incidents among the prasugrel group cast a shadow over the results. 1.7 percent of patients taking Plavix experienced serious bleeding incidents, compared to 2.2 percent of prasugrel patients.

FDA approval is crucial for Lilly; analysts say the company has no other blockbuster hopefuls in its pipeline, and patent expirations could eat away at 60 percent of its revenue in the coming years. The hope is that the FDA thinks prasugrel's benefits outweigh the increased bleeding risk. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008," said one Lilly VP. If approved, the drug will be marketed under the name Effient.

- check out this release for more
- read this article from Forbes

ALSO: TAP Pharmaceutical has submitted an NDA for TAK-390MR for the treatment of acid related diseases. Release

PLUS: Takeda has submitted an NDA for its type 2 diabetes drug alogliptin. Release

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Doubters see big obstacles for Lilly's prasugrel. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

BMS sources discount chance of Sanofi buyout

Wed, 28 Nov 2007 06:59:56 -0500

Dow Jones is quoting sources close to Bristol-Myers Squibb who say that a buyout by Sanofi-Aventis is not in the cards. BMS is betting on its pipeline for its future expansion, says the source. The possibility of a tie-up has caused considerable buzz in the M&A field, especially as Sanofi-Aventis has indicated its interest in snapping up a pharma and biotech company. A deal between BMS and Sanofi looked particularly compelling because it would have expanded the French company's U.S. reach while advancing relations between two companies with a long history of collaborating on drug projects. One of those projects includes the blockbuster Plavix, which was the subject of a closely watched patent lawsuit and will remain under patent protection until 2011.

- check out the CNN report

Related Articles:
Report: Sanofi-Aventis inks preliminary deal for BMS. Report
Patent victory reignites rumors of BMS takeover. Report
Rumor Mill: Is BMS going on the sales block? Report
Analysts buzzing about possible Bristol-Myers sale. Report
More details emerge on secret Plavix pact. Report

Investors fret over Lilly's pipeline, Prasugel data

Wed, 21 Nov 2007 06:59:55 -0500

Barron's concludes that Eli Lilly's anti-clotting drug Prasrugel will probably make it to the market, but recent safety data is likely to prevent it from becoming the kind of blockbuster the drug company badly needs. How badly? A series of upcoming patent expirations will potentially trim up to 60 percent of its revenue. Other big competitor drugs are going to go generic relatively soon. And if physicians are scared away from preferring Prasrugel to Plavix, that's one more big gap to fill on Lilly's financial horizon. Even more worrisome, analysts can't find any other potential blockbusters in the Lilly pipeline. It all spells trouble for the company's stock price, which has shrunk considerably since it issued its latest batch of Prasrugel data.

- read the report on Lilly from Smart Money

Related Articles:
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Doubters see big obstacles for Lilly's Prasrugel

Mon, 19 Nov 2007 06:59:56 -0500

The news that Eli Lilly's experimental anti-clotting drug Prasrugel was linked with a higher risk of fatal bleeding has converted a large group of analysts into disbelievers in the company's stock price. Specifically, Barron's is quoting a slate of analysts skeptical that the drug can be approved as is and worried by the absence of any other potential blockbuster in the Lilly pipeline. Lilly has maintained a much more optimistic attitude, noting that its recent crop of data indicates that the drug demonstrated efficacy in reducing heart attacks and strokes with fewer major incidents than Plavix. The analysts are betting that the FDA will want more studies--and that will take considerably more time than planned.

- read the report from Barron's

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Lilly drug outperforms Plavix, but there's a catch

Mon, 05 Nov 2007 06:59:56 -0500

Eli Lilly's shot at a blockbuster heart drug was in question this morning after researchers unveiled new data showing that prasugrel outperformed a top competitor in the anti-clotting market while increasing the risk of bleeding. At least one analyst took a look at the mixed results and shaved the drug's earnings potential. The 13,608-patient study examined the performance of prasugrel against Plavix, with Lilly's drug turning in impressive numbers for reducing the number of heart attacks and other significant events.

But the upside was shadowed by a downside in an increased number of bleeding incidents. Some prominent cardiologists told the Wall Street Journal that the study results were strong enough to gain an FDA approval, which is likely to hinge on the balance between better outcomes and the risks attached. Researchers announced a new late-stage study for prasrugel this morning.

- see the release on the study
- here's the article from The Wall Street Journal

Related Articles:
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report
Eli Lilly forges $1B diabetes deal. Report
Lilly pits drug against Plavix in head-to-head trial. Report
Lilly developing biotech drugs the old-fashioned way. Report

Lilly suspends dosing in crucial drug trial

Thu, 25 Oct 2007 06:59:58 -0400

Eli Lilly and its partner Daiichi Sankyo moved swiftly to try and contain any damage from the news that they were suspending dosing in two small trials of the blood clot preventer prasugrel--one of Lilly's most closely watched experimental programs. Officials insisted that the suspension--which was made to consider an adjustment of dosages for certain patients--would have no effect on their development timeline. That wasn't enough for investors, though, who pushed down Lilly's stock by four percent on the news. Prasrugel is considered a key program for Lilly's future, with the potential to compete against the blockbuster Sanofi-Aventis' Plavix--which earned $6 billion last year.

- see Lilly's release on the suspended trial
- check out the report from Forbes

Related Articles:
Lilly pits drug against Plavix in trial. Report
Eli Lilly forges $1B diabetes deal. Report
Daiichi aims for 60 percent growth. Report
In speech, Lilly CEO calls for drug monitoring. Report
Lilly developing biotech drugs the old-fashioned way. Report

ALSO NOTED: GSK cuts 5,000 jobs; Codexis opens Singapore lab; Reliant sets IPO terms;and much more...

Thu, 25 Oct 2007 06:59:50 -0400

> The closure of a GlaxoSmithKline's Puerto Rican plant has kicked off the plan to cut 5,000 jobs. Report

> Codexis has opened a laboratory in Singapore, its first research facility in Asia. Release

> Reliant Pharmaceuticals has set its IPO terms at $25 to $27 a share. The company has raised more than $500 million from investors. Report

> Pharmion Corporation and MethylGene have reported preliminary clinical data from the Companies' MGCD0103 Phase I/II combination trial with Gemzar. Release

> It's official: the UK's National Health Service will start using Johnson & Johnson's Velcade under an unprecedented money-back-guarantee program. Report

> Bristol-Myers Squibb's third-quarter results show what one big drug can do. Net income more than doubled to $858 million on revenues of $5.1 billion--and Plavix was the biggest reason. Report

> The European Union backed a trade protocol that will give poor countries better access to cheap generics in the event of an epidemic. Report

> The FDA slapped a new warning on Provigil, a drug for narcolepsy and other sleeping disorders made by Cephalon. Report

And Finally… Most people believe their sleep meds work better than the drugs actually do. Article

Press Release: Positive Clinical Results for DG041

Maureen Martino — Mon, 25 Jun 2007 10:04:03 -0400

Positive Clinical Results for DG041 Lead Product Development Highlights at deCODE R&D Event

Recent clinical studies support the development of DG041 as an effective anti-platelet that does not increase bleeding risk

REYKJAVIK, Iceland, June 25, 2007 -- deCODE genetics today announced progress in the development of DG041, the company's Phase II developmental compound for the prevention of arterial thrombosis. The results of the Phase IIa and clinical pharmacology studies presented today build upon previous findings demonstrating DG041's profile as an anti-platelet compound that deCODE expects will make it possible to block the formation of blood clots mediated through inflammation in atherosclerotic plaques but without increasing bleeding risk. There is a large unmet medical need for a drug with these characteristics, with applicability to the prevention of heart attack, stroke and the progression of peripheral artery disease (PAD). Drugs such as Plavix(TM) and aspirin, the current mainstays of oral anti-platelet therapy, significantly increase the risk of bleeding by broadly blocking platelet activity.

Recent advances in deCODE's therapeutic and diagnostics pipeline will be discussed at the company's annual R&D event being held today in Reykjavik. The presentations will be webcast live through the investors page of the company's website at http://www.decode.com, starting at 9am GMT/5am EDT, and will be archived on the site. Among the highlights to be discussed are:

DG041 -- Arterial thrombosis.

DG041 is a novel, first in class antagonist of the EP3 receptor for prostaglandins E2. deCODE initially identified EP3 as a target by isolating variants in the gene encoding the EP3 receptor for prostaglandins E2 (PGE2) that approximately double the risk of PAD, a common and debilitating atherosclerotic condition in which the flow of blood to the legs is progressively constricted. The mechanism through which EP3 modulates platelet aggregation is distinct from those targeted by aspirin and Plavix(TM). Following deCODE's gene discovery, work by leading international scientists has demonstrated in mice that PGE2 is produced in atherosclerotic plaques, promoting the formation of clots immediately at the sites of plaque but not over normal blood vessels. The formation of these thrombi is dependent on signaling through EP3. This pathway is left largely unaffected by existing anti-platelet drugs such as aspirin and Plavix(TM).

deCODE's medicinal chemistry group discovered DG041 as a means to prevent arterial thrombosis by inhibiting the activity of EP3. In animal studies and extensive Phase I clinical testing completed in mid-2006, DG041 was shown to effectively inhibit platelet aggregation through this pathway without increasing bleeding time, and to be safe and well-tolerated at all doses tested. Late last year, deCODE began a Phase IIa randomized, placebo-controlled clinical trial of DG041 in 144 PAD patients, to examine safety and tolerability of doses of 100mg twice a day and 400mg twice a day and their effect on a range of biomarkers. Because a large proportion of patients in this trial and subsequent trials would be taking other anti-platelet compounds, the company simultaneously began work to identify a sensitive biomarker of anti-platelet activity that could discriminate between the effects of DG041 and these other agents. The vasodilator-stimulated protein (VASP), which normally holds platelets in a quiescent state when phosphorylated but causes platelets to bind when dephosphorylated upon activation of EP3, was found to provide such a biomarker. The company thus began a clinical pharmacology study to examine DG041's effectiveness in blocking VASP-mediated platelet activation.

The results of these studies presented today provide a compelling demonstration of DG041's potential as a next-generation oral anti-platelet therapy -- an effective means of preventing arterial thrombosis specifically at the sites of plaque lesions in the vasculature. In the Phase IIa study, DG041 was found to reduce several markers of inflammation -- c-reactive protein (CRP), monocyte chemotactic protein 1 (MCP1), and soluble intracellular adhesion molecule (sICAM) -- in a dose-dependent manner. Ankle- brachial index (ABI) measurements -- which gauge the strength of blood flow to the legs and are a key measurement of the severity of PAD - also showed improvement in both DG041 treatment groups. There were no drug-related serious adverse events in the study and no discernible difference in other adverse events between the DG041 and matched placebo groups.

The results of the placebo-controlled clinical pharmacology study also announced today demonstrate that in a concentration-dependent manner DG041 dramatically inhibits platelet activation mediated through VASP as well as platelet aggregation. DG041 also reduced levels of another indicator of platelet activation, p-selectin. Moreover, the desired effect on VASP appears to be achievable at doses lower than previously anticipated. deCODE is thus very encouraged that in targeting EP3, the company is advancing a potentially major new approach to anti-platelet therapy - one that acts specifically to prevent arterial thrombi, targets a pathway not addressed by existing drugs, with minimal impact on normal platelet function.

DG031 and DG051 - Heart attack

In its drug development programs targeting the leukotriene pathway for the prevention of heart attack, deCODE is advancing the reformulation of its FLAP inhibitor DG031 for re-entry into clinical trials. A lead formulation has been identified and a 3-month accelerated stability study completed. The company believes that a once-a-day dosing regimen may provide even better pharmacodynamic effect than the previous twice-a-day regimen. The company expects to be ready to restart Phase III testing near year end. DG051, an inhibitor of leukotriene A4 hydrolase (LTA4H), has successfully completed single- and multiple-dose Phase I testing. It has demonstrated potent, dose-dependent lowering of the production of leukotriene B4, the end product of the leukotriene pathway which deCODE's genetics and biology work has pinpointed as a key means of modulating risk of heart attack. DG051's pharmacokinetic profile supports its development with once-a-day dosing, with a very satisfactory safety and tolerability profile. The company plans to initiate Phase II clinical testing of DG051 later this year.

Diagnostics and gene discovery

In April deCODE launched deCODE T2(TM), the company's first DNA-based, reference laboratory test for gauging individual risk of type 2 diabetes. The company will provide an update on its marketing strategy for its diagnostic tests and will discuss the upcoming launch of its deCODE AF(TM) test, which detects a genetic variant that confers risk of atrial fibrillation, the leading cause of cardiogenic stroke. The company is also developing tests for sequence variants associated with risk of heart attack, glaucoma and several other conditions in which deCODE has recently isolated risk variants. Since the beginning of the year, deCODE has dramatically accelerated its gene discovery work, publishing major new risk variants for heart attack, breast cancer, prostate cancer, type 2 diabetes, among others. The company expects to announce many additional discoveries in the weeks and months ahead. deCODE is underscoring its position as the global leader in the identification of genetic risk factors for common diseases, building on this leadership by bringing together its human genetics resources and capabilities with the power of genome-wide SNP association chips.

About deCODE

deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of drugs and diagnostics for common diseases. deCODE is a global leader in gene discovery -- our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. deCODE is also leveraging its expertise in human genetics and integrated drug discovery and development capabilities to offer innovative products and services in DNA-based diagnostics, bioinformatics, genotyping, structural biology, drug discovery and clinical development. deCODE is delivering on the promise of the new genetics(SM). Visit us on the web at http://www.decode.com.

Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

Promising results for DeCode's blood clot drug

Mon, 25 Jun 2007 00:01:34 -0400

DeCode Genetics announced today that a mid-stage study of its arterial thrombosis treatment showed positive results in a Phase II study. The company says it expects DG041 will make it possible to block the formation of blood clots mediated through inflammation in atherosclerotic plaques but without increasing bleeding risk. With the development of DG041, DeCode is taking aim at drugs such as Plavix and aspirin, the current market leaders of oral anti-platelet therapy.

- see DeCode's release

Related Articles:
DeCode alleges ex-employees stole trade secrets. Report
DeCode IDs tablet problem, suspends pivotal trial. Report
DeCode touts early heart data. Report
DeCode launches genetic trial. Report

Report: Sanofi-Aventis inks preliminary deal for BMS

Sun, 28 Jan 2007 19:01:38 -0500

A French newspaper is reporting that Sanofi-Aventis has signed a pre-merger pact with the troubled Bristol-Myers Squibb. Aside from the bragging rights associated with creating the world's biggest pharma company--ranked by sales--it would join two companies that already share marketing rights for the blood-thinner Plavix as well as the hypertension drug Avapro. But some analysts say that any pact would hinge on a successful conclusion to the litigation over a generic competitor for Plavix, which accounts for a big chunk of BMS's revenue and its market value. Sanofi has a market capitalization of $123 billion, more than twice that of BMS. Buying its U.S. marketing partner would give the French company greater direct access to the critical North American market.

- read the report on the deal from USA Today

Related Articles:
Analysts buzzing about possible Bristol-Myers sale. Report
More details emerge on secret Plavix pact. Report
Cornelius get big payday for BMS temp job. Report

Cornelius get big payday for BMS temp job

Mon, 06 Nov 2006 19:01:38 -0500

Interim Bristol-Myers Squibb CEO James Cornelius is getting the corporate red carpet treatment for the temp job he has. If he stays until the end of the first quarter of next year, he'll get a $1.25 million salary, a guaranteed $1.06 million bonus and options on 180,000 shares. Then there's his access to the corporate jet and a $25,500 a month apartment in New York. If he stays through 2007, those numbers go up. The board apparently loves Cornelius--who used to run Guidant--but can't get him to agree to stay for the longterm. A search committee, meanwhile, will try to find someone who can turn the company around after a series of disastrous mistakes opened the door to a generic version of Plavix, their big moneymaker.

- read the article on BMS from the Wall Street Journal (sub. req.)

Related Articles:
Analysts buzzing about possible Bristol-Myers sale. Report
BMS board fires CEO Dolan, general counsel. Report
Bristol-Myers Squibb shelves diabetes drug. Report
Bristol-Myers pulls Tequin. Report

Medical device makers to fund stent safety study

Maureen Martino — Wed, 25 Oct 2006 09:37:48 -0400

Earlier this year, medical device giants Johnson & Johnson and Boston Scientific were involved in a knock-down, drag out fight over the acquisition of Guidant. But in light of recent reports that blood clots can form within drug-coated stents, the former rivals as well as several other device makers have come together to fund a 10,000-person study of the technology. “The new study will monitor patients for blood clots for two years, a period in which…about 100 blood clots are expected to appear. Researchers will look at a variety of factors that may contribute to the clots,” reports the Boston Globe. The research is being carried out at the North Carolina-based Carolinas Heart Institute of Charlotte, and though the device makers are funding the study, researchers insist that the funding will have on influence on the outcome.

There’s no doubt that the questions surrounding stent safety and the results of this study have serious financial implications for J&J and Boston Scientific. Boston Scientific’s Taxus and J&J’s Cypher and the two best-selling stent brands, but in recent concerns over stent safety have led to a decreased use of stents and an increase in use of drugs such as Plavix for treating clogged coronary vessels. Report

BMS board fires Dolan, general counsel

Mon, 11 Sep 2006 20:01:38 -0400

The high-wire act of Bristol-Myers Squibb CEO Peter Dolan has ended in a swift fall. Dolan was ousted today as the company's board met to consider a recommendation from a federal monitor that he be fired. General counsel Richard Willward also got the axe. Several news organizations reported early today that former federal judge Frederick Lacey urged the board to fire Dolan and the company's chief counsel at a special session last night. Lacey was appointed as a monitor after the company agreed to deferred-adjudication in a case of "channel stuffing," in which the company sold large quantities of therapeutics to wholesalers in order to make its quarterly numbers. In that case, Bristol-Myers agreed to stay out of trouble for two years. But Lacey has concluded that Dolan's bungled attempt to delay a generic version of Plavix broke the terms of its settlement and ended any chance of his rehabilitation. Investors may well be happy to see Dolan go after a period of intense turmoil. Director James Cornelius now takes over as interim CEO and company secretary Sandra Leung is interim general counsel.

- read the article from The Times Online

Rumor Mill: BMS board may decide on Dolan's fate

Sun, 10 Sep 2006 20:01:36 -0400

Speculation is continuing to mount that the board of Bristol-Myers Squibb may decide to drop the axe on CEO Peter Dolan at its meeting tomorrow. Of course, there's no hard evidence to back that up, but the analysts have been buzzing for weeks that the board has to take some decisive action in Dolan's case after he blundered his way through a failed attempt to prevent a generic competitor to Plavix. A federal judge recently granted a temporary injunction against generic Plavix, but allowed a mountain of generic supplies already on the market to course its way through the supply pipeline. That decision alone could cost the company more than half a billion dollars. If Dolan does go, it will mark the third recent exit of a big pharma CEO, following the departures from the executive suites at Merck and Pfizer.

- read the article on Dolan from The Wall Street Journal (sub. req.)

ALSO NOTED: Ipsen licenses Acapodene; Committee recommends Fragmin; and much more...

Wed, 06 Sep 2006 20:01:30 -0400

> France's Ipsen has agreed to pay $30 million to license GTx's Acapodene for all indications except breast cancer in Europe. Acapodene is in Phase III for cancer prevention. Report

> An FDA advisory committee has recommended that the agency expand the approval of Pfizer's Fragmin to include the prevention of blood clots in cancer patients. Report

> The newly renamed Caden Biosciences raised $5.85 million in venture capital and is moving to Wisconsin. Report

> Metastatix, an Atlanta-based biopharmaceutical company developing small-molecule drugs to treat cancer and HIV, announced today it has raised a $3.6 million Series A financing round. Release

> The Wall Street Journal provides a blow-by-blow account of Bristol-Myers Squibb's disastrous campaign to hold onto Plavix. CEO Peter Dolan comes in for a large portion of the blame. Article

> Sanofi-Aventis has pulled its marketing application for the heart arrhythmia therapy Multaq following last month's FDA rejection and fresh competition from generic Plavix. Report

> Chutes & Ladders: Celsion CEO Lawrence Olanoff has resigned to return to Forest Labs as COO. CFO Anthony Deasey will be interim CEO. Report

> Zestra Laboratories of Charleston, SC has raised $6 million in a private placement. Release

> A federal appeals court has ruled that Mylan Laboratories did not infringe on J&J's patent of a urinary incontinence therapy. Report

And Finally… Better therapies and earlier interventions are helping drive down the rate of deaths from cancer in the United States, with the biggest declines for men. Article

FDA turns thumbs down on Multaq

Thu, 31 Aug 2006 20:01:37 -0400

Sanofi-Aventis says that the FDA has rejected its heart drug Multaq (dronedarone), evidently unsatisfied with the data provided to support its application. Multaq is designed to treat atrial fibrillation. Sanofi-Aventis hasn't given up on the drug, though. The company says it plans to refile for approval in the first half of 2008, after it receives a fresh batch of data from an ongoing study. Last February the FDA rejected Sanofi-Aventis' bid to market Acomplia. And analysts weren't happy to see the European drug maker rejected again as it hurries to shore up its revenue in the face of new generic competition for Lovenox and Plavix.

- here's the International Herald Tribune's report on Multaq

PLUS: Sanofi-Aventis announced that the trial to decide on its continued exclusive control of Lovenox has been postponed to early December. Report