prasugrel

Daiichi, Lilly: still no word on prasugrel

Maureen Martino — Fri, 17 Oct 2008 10:44:50 -0400

Responding to "recent media speculation regarding the status of the prasugrel new drug application," Eli Lilly and Daiichi Sankyo said they still have received no word about the fate of prasugrel, a potential blockbuster anti-clotting drug that would compete with Plavix if approved. "If approved" being the key words there. The companies have been waiting for some time for an answer. In September, the FDA once again delayed a decision after initially postponing it in June. Clinical data on prasugrel showed the drug outperformed Plavix but also increased the the risk of bleeding.

"Daiichi Sankyo and Eli Lilly reiterated today that they continue to have discussions with the FDA regarding the review of this application. The companies have not been notified of any regulatory action for the new drug application or of any decision to have an advisory committee to review prasugrel," the companies said in a joint statement.

- see the release for more

FDA again delays prasugrel decision

John Carroll — Mon, 29 Sep 2008 12:51:26 -0400

Analysts were in for a surprise with the news that the FDA is once again delaying any decision on prasugrel, a potential blockbuster anti-clotting drug developed by Eli Lilly and Daiichi Sankyo. The agency said last June it would need three extra months to review the drug, and now it says regulators need even more time.

Some of the analysts haven't lost hope, though, saying that absent an agency request for more data, any delay should be relatively short. But J.P. Morgan's Chris Schott has been sounding a cautionary note on that score. The Wall Street Journal, meanwhile, notes that the folks at Sanofi-Aventis and Bristol-Myers can only be ecstatic to hear that Plavix gets another stay on any new competition.

- check out the Lilly and Sankyo release
- read the report from the Wall Street Journal

Deadline clock running on Lilly's next big blockbuster

John Carroll — Mon, 22 Sep 2008 11:51:16 -0400

One of the biggest moves in biopharma this week will turn on the FDA's decision on prasugrel, a blood-clot drug advanced by Eli Lily and Daiichi Sankyo. Analysts pegged the decision as one of the biggest in quite some time for Lilly, which could push its stock up or down by as much as 10 percent once the agency makes its ruling by the September 26 deadline.

With no advisory guidance to work with, though, the analysts are somewhat mystified whether prasugrel's mixed data--demonstrating efficacy for heart ailments but raising worries about bleeding--will win an approval or not. The agency has been tougher to convince recently, as it grows more wary of potential drug safety fiascos. If prasugrel does get a green light, the drug is a likely blockbuster on the retail drug market.

"It's hard to call this one," Les Funtleyder, a drug analyst with Miller Tabak & Co., told the Star-Tribune. "The FDA is very cautious these days, and rightfully so. It has taken a very strict view of what it will approve."

- read the report from the Indianapolis Star-Tribune

ALSO: GlaxoSmithKline says that the FDA is still reviewing its clotting drug Promacta. Report

Biopharma sees tougher FDA approval process

John Carroll — Mon, 30 Jun 2008 09:55:31 -0400

The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once held high hopes for and it may soon axe a third. Delays on prasugrel and Cordaptive are adding to the uncertainty and tomorrow an FDA panel will ponder tougher approval standards for diabetes drugs.

"What will it take to get new drugs approved?" Schering-Plough CEO Fred Hassan asks. "The point is, we don't know."

The WSJ notes that it's getting tougher to win an FDA approval even as the number of NDAs is already scraping a 24-year low.

- read the report from the Wall Street Journal

ALSO: Developers say FDA may force higher costs, more time for diabetes programs. Article

FDA delays review of Eli Lilly’s would-be blockbuster

John Carroll — Tue, 24 Jun 2008 10:24:40 -0400

Shares of Eli Lilly slipped slightly after the FDA announced that it would extend its review of the closely watched anti-clotting drug prasugrel by three months. Daiichi Sankyo and Lilly both believe they have a potential blockbuster on their hands. And the two companies also confirmed plans to launch a late-stage trial that would compare the effectiveness of prasugrel with Plavix, the standard therapy in the field.

Data on prasugrel indicates that the drug can work better than Plavix in preventing clots, but it also increases the risk of bleeding in some patients. For analysts, that kind of safety risk is likely to lead the FDA to limit use of the drug to a more narrowly defined patient population. But the market potential remains large.

- read the release on the delay
- check out the Dow Jones report

Relaed Articles:
Prasugrel gets priority review
Lilly submits prasugrel NDA
Lilly drug outperforms Plavix, but there's a catch
Doubters see big obstacles for Lilly's prasugrel
Lilly pits drug against Plavix in trial

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

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