heart drug

ALSO NOTED: Salix gets approvable letter; Intermune drug hits the fast track; and much more...

Mon, 19 May 2008 06:59:50 -0400

> Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Schering-Plough CEO's 2007 compensation package was probably artificially inflated by the fact that sales-damaging study results were held back until early January 2008. Report

> Salix says it has received an approvable letter from the FDA for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. The company says it should be able to provide a complete response to the letter in a matter of days. Release

> The FDA has put Intermune's drug pirfenidone--for idiopathic pulmonary fibrosis--on the regulatory fast track. Story

> Holmes Biopharma announced that its clinical research operations in Omaha, Nebraska have been disrupted due to a working capital deficiency. Release

> MorphoSys has extended its research contract with Schering-Plough by a year. Report

> Biophage Pharma has sold the assets of its Immunotox Labs Division to Validapro BioSciences Inc. for $400,000 in cash and the assumption by Validapro Biosciences of certain liabilities. Release

> In a deal with the U.S. Department of Justice, the Canadian drugmaker agreed to pay almost $25 million to settle claims that it paid docs and their office managers to get patients onto its Cardizem heart drug. Report

> The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Report

And Finally... A simple gene test may soon be available that will eliminate up to half of the potential patients for the therapy. Report

SPOTLIGHT: Cardiome delays analysis

Mon, 26 Nov 2007 06:59:53 -0500

There's plenty of buzz this morning about Cardiome Pharma, which announced that it is delaying an interim analysis on a key heart drug--vernakalant--so it can add data from more patients in the Phase IIb study. Analysts say the company is likely involved in partnership talks. Cardiome now expects to release the analysis in March. Release

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

ALSO NOTED: VaxGen gains extension; Merck wins latest Vioxx suit;and much more...

Wed, 15 Nov 2006 19:01:30 -0500

> Officials at HHS have granted VaxGen a one-month extension of its deadline to resolve a clinical hold on its troubled development program for an anthrax vaccine. The agency has threatened to cancel its contract with VaxGen unless it resolves the hold. Report

> Biotech drugs take longer and cost more than the traditional medicines fielded by the FDA, according to a new survey from Tufts University's Center for the Study of Drug Development. On average, a complex biologic costs $1.2 billion to approval over a period of 97.7 months. Report

> A federal jury has cleared Merck of any wrongdoing in the latest federal trial over Vioxx. Report

> Daryl Faulkner has been named president and CEO of Digene. Faulkner recently retired from Invitrogen. Report

> CollaGenex has sold $45.5 million in stock. Report

> Migenix has raised $10 million through a bought-deal financing package. Release

> AtheroGenics CEO Russell Medford says the company is on track to deliver late-stage data on the heart drug AGI-1067 in March of next year. Report

> Scientists at the University of Zurich have used stem cells obtained from fetal fluid to grow new heart valves for repairing damaged hearts. Report

> A host of experimental stem cell therapies are poised to make the switch from animal studies to clinical development. But as human studies begin, experts have been quick to warn against giving into the hype that life-saving treatments are just around the corner. Report

And Finally... Researchers have found two genetic mutations in H5N1 necessary to trigger a human pandemic. Their work may help signal a coming outbreak. 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

Pfizer reverses stand on torcetrapib combo

Tue, 25 Jul 2006 20:01:38 -0400

After being subjected to a wave of criticism, Pfizer says that it will market its experimental heart drug torcetrapib as a standalone therapy rather than in combination with Lipitor. The experimental heart drug, which raises the level of good cholesterol, is considered a prime candidate for blockbuster status. Pfizer's strategy had been to require patients who wanted torcetrapib to take the drug in combination with Lipitor, which lowers bad cholesterol. And that would have potentially clawed a large market share away from companies with products that compete with Lipitor, like Zocor. Pfizer says that it is spending $800 million to develop torcetrapib, but analysts say that could well be rewarded by multibillion-dollar annual sales.

- here's the article on Pfizer from The New York Times

ALSO NOTED: Orion nixes Phase III; Xechem granted orphan status; Amgen to pay Mass General; and much more...

Mon, 05 Jun 2006 20:00:50 -0400

> Finland's Orion Corp. says that Phase II data for its oral heart drug levosimendan weren't good enough to warrant a late-stage trial. Report

> The FDA has granted Xechem orphan drug status for a sickle cell therapy. Report

> Amgen has agreed to pay Massachusetts General $186 million to settle all royalty claims over the rheumatoid arthritis drug Enbrel. Report

> The U.S. subsidiary of India's Glenmark Pharmaceuticals has signed a deal in which Paul Capital Partners Royalty Fund will invest $27 million to finance the development of 16 dermatological products. Report

> Chutes & Ladders: Isolagen has named Nicholas L. Teti Jr. as its new chairman and CEO. Report

> P&G and Hoffman-LaRoche are fighting a court battle over the ad claims made for the osteoporosis drug Boniva. Report

> Charles River Laboratories has plans to issue $300 million in notes to investors. Report

> Wyeth and Progenics have outlined plans for their joint development of methylnaltrexone. Report

> Acusphere says that an experimental new system for testing coronary heart disease met two of three goals in a late-stage trial. Report

And Finally…The use of antipsychotics among children and adolescents increased fivefold between 1993 and 2002. Article

Cardiome shares tank on FDA rejection

Tue, 30 May 2006 20:01:37 -0400

Canada's Cardiome Pharma watched its stock take a nasty dive overnight after it announced that the FDA had not accepted a marketing application from its development partner, Astellas Pharma, for the heart drug RSD1235. The FDA told Astellas in a letter that its application contained omissions and inconsistencies. Cardiome was quick to note that the FDA did not reject the drug. Cardiome stands to gain a $10 million milestone fee if the marketing application is accepted. Its shares lost about a quarter of their value in overnight trading.

- here's the AP report on Cardiome

NitroMed lays off researchers in shakeup

Thu, 30 Mar 2006 19:01:35 -0500

Reeling from low sales of its newly-approved heart drug BiDil, NitroMed has announced it is laying off 30 researchers and is looking for partners for other experimental heart therapies in its pipeline. The Lexington, MA-based company's CEO and CFO had already been let go earlier this month, and NitroMed is focusing its efforts on gearing up sales of BiDil. About 150 contract sales people are being made full time employees.

- read the Boston Herald report

Slumping Natrecor sales spur layoffs at Scios

Thu, 23 Feb 2006 19:01:38 -0500

With sales of its heart drug Natrecor hampered by reports of safety concerns, Johnson & Johnson announced that about 150 of Scios' 900 employees will receive pink slips. Sales and marketing workers will be among the most heavily hit, along with employees in the unit's Fremont, CA headquarters. Sales peaked in 2004 at $400 million but began to slide as medical experts raised possible links to kidney problems and death. The Justice Department is also looking at whether Scios improperly marketed the drug for an unapproved use. The company has denied any illegal off-label promotions. Johnson & Johnson paid $2.4 billion for the drug about three years ago.

- here's the report from The New York Times for more

Cardiome unveils dramatic results for atrial fibrillation therapy

Thu, 29 Sep 2005 20:01:38 -0400

Canada's Cardiome and development partner Astellas said that a new set of Phase III data for their heart drug RSD1235 shows that 52 percent of patients with abnormal heartbeats--or atrial fibrillation--developed regular heartbeats after taking the drug. Only 4 percent of the patients taking a placebo saw their heartbeats return to normal. Those results are in line with an earlier Phase III data and create a case the drug companies will now present to the FDA. Cardiome shares were boosted by the results, which were disclosed after markets closed on Thursday.

- read this feature from Canada.com for more

Schering-Plough buys Millennium's stake in heart drug

Sun, 24 Jul 2005 20:01:38 -0400

Schering-Plough is buying out Millennium Pharmaceuticals' share of the heart drug Integrilin for a minimum of $250.5 million. Of that, $35.5 million will come as an upfront payment with a minimum of $85 million per year for the next two years in royalty payments. Millennium will also pocket $45 million to $50 million for stockpiles of the pharmaceutical.

"Acquiring the balance of US rights to Integrilin will give us direct control of this important therapy in its largest market. This is yet another long-term action we are taking to increase our importance to health providers and patients and to become a global leader in the very important area of cardiac care," said Fred Hassan, Schering-Plough chairman and CEO.

- read this story from TheStreet.com for more

PLUS: Cambridge, Massachusetts-based Millennium swiftly announced that the revised deal with Schering-Plough would lead to the elimination of some 200 jobs. Story

ALSO NOTED: Sepracor touts Lunesta trial; SkyePharma outlines gains; ArQule highlights cancer results; and much more...

Sun, 17 Jul 2005 20:00:50 -0400

> Sepracor announced that a new study of Lunesta demonstrated that it improved the sleep of premenopausal and menopausal women suffering from insomnia. Lunesta was approved by the FDA last December for people who have trouble sleeping through the night. Report

> SkyePharma's drug development partner First Horizon has released the heart drug Trigline in the US market, the first of eight strategic gains marked by the London-based developer at its annual meeting. Release

> ArQule is touting preclinical data showing that activating Chk2 in the absence of chemotherapy kills cancer cells. Report

> Xencor has inked a new collaboration deal to develop monoclonal antibodies with improved efficacy -- this time with Centocor. Release

> The FDA approved an implantable device developed by Cyberonics for treating depression. Story

> Bayer HealthCare's Avelox IV has been approved in Europe to treat complicated skin infections. Release

And Finally... The absence of generic competition is helping to keep the cost of biotech drugs high. Article

NitroMed pricing plan for BiDil comes under fire

Thu, 07 Jul 2005 20:01:39 -0400

NitroMed has come under attack for its decision to sell BiDil -- a heart drug for blacks -- at $1.80 per pill, twice the amount of several other drugs. The biotech has coupled that price, though, with a plan to provide the drug at a deep discount to patients without drug coverage while poor people without drug coverage can obtain it for free. Dr. Steven Nissen at the Cleveland Clinic told The New York Times that the decision could price the drug beyond the reach of many patients. NitroMed says that they feel it's important to make sure that BiDil is available to everyone who needs it.

- read this story from The New York Times for more

Cardiologists suggest Natrecor limits

Tue, 14 Jun 2005 20:01:35 -0400

A panel of cardiologists has dealt Johnson & Johnson another setback on Natrecor, recommending that the use of the heart drug be reserved for seriously ill patients arriving at a hospital. It said the drug should not be given for outpatients and that another clinical trial was needed to clarify how safe the drug is. Dr. Eugene Braunwald of Harvard Medical School led the panel. Despite their reservations on the use of Natrecor among outpatients, the panel also recommended that a clinical trial into the efficacy of the drug among outpatients should continue.

The FDA approved Natrecor specifically for patients who arrive at the hospital so ill that they had trouble walking or breathing. But sales of the drug for outpatient use have swelled each year over the past four years.

- read this article from The New York Times for more