Biotech Values

[DewDiligence]

BI Starts Phase-2 Trial of Dabigatran in ACS

[Anticoagulants are one of the most promising drug classes from both a medical and an economic standpoint. Unlike Rivaroxaban from JNJ (#msg-25147464) and Apixaban from BMY/PFE (#msg-19134406), which inhibit FXa, Dabigatran from Boehringer Ingelheim inhibits FIIa (a.k.a. thrombin). Therefore, Dabigatran is being tested in acute coronary syndromes (ACS). Dabigatran has already completed one phase-3 trial in prevention of DVT, where it was non-inferior to Lovenox (#msg-21155926). MNTA’s M118, which blocks both FXa and FIIa (#msg-24457684, #msg-24393520) and is in phase-2 for stable angina, is a potential competitor to Dabigatran in ACS that has the benefit of being reversible.]

http://www.reuters.com/article/marketsNews/idUKL07354020071209

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Sun Dec 9, 2007 9:04am EST

FRANKFURT (Reuters) - Boehringer Ingelheim has started a mid-stage study for its experimental pill dabigatran etexilate to treat acute coronary syndrome (ACS) patients, the unlisted German drugs company said on Sunday.

"The addition...shows the promise and additional potential we see in this new compound," said Andreas Barner, a board member of Boehringer, in a statement.

The study, referred to as RE-DEEM, will evaluate safety and efficacy with four doses of orally administered dabigatran in ACS patients who have had a myocardial infarction and are therefore at high risk of further cardiovascular attacks.

In the study, dabigatran will be given twice daily in addition to a standard dual anti-clotting treatment [i.e. aspirin + Plavix or a similar drug] and compared to a standard treatment plus a placebo.

ACS accounts for 2.5 million hospital admissions worldwide and is a major killer in Western countries.

Dabigatran had been proved to be as effective as injections of Sanofi-Aventis' Lovenox in preventing blood clots after hip surgery.

The drug is a potential rival to Bayer's big new drug hope rivaroxaban, which has proved superior to Lovenox in a late stage study.

Bayer and Boehringer had submitted their products to European authorities for approval in a first indication.

A Boehringer spokeswoman said the company expected to bring dabigatran to the market earlier than Bayer.

Bayer, Boehringer and rivals have been seeking new oral anticoagulants since Exanta, a once-promising medicine from AstraZeneca Plc, failed to win U.S. Food and Drug Administration approval in 2004 after being associated with liver toxicity.

Industry analysts believe a successful product could be a multi-billion-dollar-a-year seller.

Dabigatran works by blocking thrombin, a key enzyme for blood clot formation, while Bayer's drug inhibits a protein called Factor Xa.
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