Lovenox

Bayer, J&J tout rivaroxaban data

Fri, 30 May 2008 06:59:58 -0400

In a head-to-head study against Sanofi's Lovenox, Bayer and J&J's oral anti-clotting drug rivaroxaban proved superior in preventing venous blood clots in patients who underwent total knee replacement surgery. Lovenox, which is the current standard of care, is given twice daily. "Only 6.9 percent of patients treated with Rivaroxaban experienced thomboembolisms, compared with 10.1 percent for the comparison group...This reflects a 31 percent decrease in relative risk," noted Dow Jones. This was the third trial to demonstrate the drug's superiority over Lovenox. An NDA is planned for the third quarter of this year. The drug is also being developed for stroke prevention in atrial fibrillation and VTE treatment.

- see the rivaroxaban release
- here's the Dow Jones brief

ALSO NOTED: AIDS vaccine researchers years away from success; Amgen reports earnings; and much more...

Fri, 25 Apr 2008 06:59:50 -0400

> Following a series of major setbacks trying to develop a vaccine for AIDS, pessimistic researchers say they're years away from success. Report

> AstraZeneca and Amgen have posted their earnings. Earnings report

> FDA inspectors found 49 problems at Merck's West Point, PA, vaccine plant--problems independent experts called "serious concerns." Merck report

> Sanofi-Aventis announced that small amounts of an impurity have been found in batches of its heparin injection Lovenox. Sanofi report

> You can't say Takeda Pharmaceutical is unwilling to take risks. The Japanese drugmaker went out on an $8.8 billion limb in bidding for the U.S. biotech Millennium Pharmaceuticals. Investors weren't impressed; they dragged share prices down by 8 percent almost immediately. Report

> After more than a decade of attempts, it looks like Congress might finally pass a bill that would block health insurers from denying coverage to otherwise healthy persons based on their genetic predisposition to come down with a particular disease. Report

> GSK is confident it can prevail in vaccine battle. Report

> Genocea Biosciences has been recognized as the best vaccine startup company at a meeting of the World Vaccine Congress in Washington D.C. Report

And Finally... The Democratic Party may not have its nominee yet, but Big Pharma apparently does. At a mock election this week at the DTC National Conference, Barack Obama trounced Hillary Clinton with 59 percent of the vote to her 40 percent. Election report

Boehringer wins approval in anti-clotting drug race

Thu, 27 Mar 2008 07:59:56 -0400

Boehringer Ingelheim has stolen a march on arch rival Bayer, winning European marketing approval for a new anti-clotting agent--Pradaxa--that is likely to provide Lovenox with considerable competition. Boehringer's pill formulation is likely to be attractive compared to the injection of Lovenox, which earned €2.6 billion for Sanofi-Aventis last year. Bayer, meanwhile, has been advancing Xarelto for this market, which it forecasts will garner more than $2 billion a year. Pradaxa gets its first rollout in Germany and the UK in the next few weeks.

This first license for Pradaxa "marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi," says Boehringer R&D chief Andreas Barner.

- here's the release on the approval
- read the story in PharmaTimes

Related Articles:
Boehringer anti-clotting drug performs in Phase III. Report
Pfizer, BMS report Phase II clotting trial success. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Bayer buoyed by success in late-stage clotting trial. Report

FDA rejection raises serious questions for Momenta

Wed, 07 Nov 2007 06:59:54 -0500

The fallout over the FDA's rejection of Momenta's generic version of Lovenox--a rare setback for any developer--is continuing to dent the drug developer's reputation. Analysts have zeroed in on the implications the rejection has for Momenta's whole approach to development. As Cowen & Co. analyst Eric Schmidt noted, "We expect investors to be skeptical around Momenta's entire technology platform, pipeline and complex generic strategy." Ouch.

- read the report from The Wall Street Journal
- take a look at yesterday's release on the rejection

Related Articles:
Momenta shares tumble after FDA rejection. Report
Momenta sees delay in generic Lovenox development. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Sandoz takes big stake in Momenta. Report
Lovenox reduces cardio risks but can cause bleeding. Report

Momenta shares tumble after FDA rejection

Tue, 06 Nov 2007 06:59:58 -0500

It's Momenta Pharmaceuticals' turn at the Wall Street whipping post as investors respond to the news that the FDA has rejected its generic version of the anti-clotting drug Lovenox, which is made by Sanofi. The company said the FDA's non-approvable letter cited an inadequate look at the drug's possible effects on the immune system. The agency's response is a heavy blow to Momenta, which had been looking for an approval to help gin new revenue for its research work. Its stock crashed in pre-market trading, losing almost half of its value. Momenta's partner, Sandoz, received the rejection letter.

- check out Momenta's release on the rejection
- read the AFX report for more info

Related Articles:
Momenta sees delay in generic Lovenox development. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Sandoz takes big stake in Momenta. Report
Lovenox reduces cardio risks but can cause bleeding. Report