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DewDiligence

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Re: DewDiligence post# 63106

Friday, 07/25/2008 11:11:39 AM

Friday, July 25, 2008 11:11:39 AM

Post# of 252586
EMEA Approves Bayer’s Xarelto for VTE Prevention

[Xarelto (rivaroxaban) is an oral FXa inhibitor; if eventually approved in all indications where it is being tested, Xarelto figures to be the largest-selling drug Bayer has ever had (including aspirin). The clinical data on which the EMEA's approval is based is shown in #msg-29660864 (knee surgery) and #msg-25147464 (hip surgery).

If approved by the FDA, Xarelto will be marketed in the US by JNJ.

The chart in #msg-29662519 shows the rationale for the Xarelto program. Please see #msg-29698599 for musings on how Xarelto and other oral anticoagulants will affect the addressable market for generic Lovenox and MNTA’s M118.]

http://www.reuters.com/article/marketsNews/idINL568356720080725

› Fri Jul 25, 2008 10:31am EDT
By Ben Hirschler

LONDON, July 25 (Reuters) - Bayer AG's experimental anticoagulant Xarelto, its biggest new drug hope, has been recommended for approval by the European Medicines Agency, lifting the German company's shares 4 percent.

The drugs watchdog said on Friday its Committee for Medicinal Products for Human Use (CHMP) had backed Xarelto for the prevention of blood clots after hip or knee surgery. Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a couple of months.

Bayer, which estimates eventual global peak sales of the drug could reach 2 billion euros ($3.14 billion) for all indications, said it was particularly pleased by the speedy positive opinion.

"We received it only nine months after the submission -- very fast compared to average," said Kemal Malik, member of the Bayer HealthCare executive committee, responsible for product development.

Shares in the German drugs and chemicals group were up 4 percent at 56.15 euros by 1426 GMT, as investors welcomed the green light, which reinforces Bayer's reputation for having a promising new drug pipeline.

Bayer had previously said it expected Xarelto to go on sale in Europe by the end of the year.

GROWTH STORY

Citi analysts said progress with Xarelto showed Bayer was transitioning from a restructuring play -- following its 17 billion euro acquisition of Schering in 2006 -- to a growth story driven by a maturing pipeline of new medicines.

The point was underscored by the appointment of a new head of Bayer HealthCare's pharma division. Bayer said it had made Andreas Fibig head of the unit because the integration of Schering had been largely completed, allowing HealthCare head Arthur Higgins to step back from overseeing merger activities.

Higgins will now concentrate on the broader strategy for Bayer HealthCare, which also includes animal health, consumer healthcare and diabetes care.

Outside Europe, regulatory filings for Xarelto have been submitted in more than 10 other countries, including Canada and China. It is expected to be submitted for approval shortly in the United States, where it will be marketed by Bayer's partner Johnson & Johnson..

Although the initial use of Xarelto will be in preventing blood clots after hip- and knee-replacement surgery, the big commercial potential lies in using it to prevent strokes in people with atrial fibrillation, a common heart arrhythmia.

The medicine, which is also known by the generic name rivaroxaban, is taken as a single tablet, once daily.

It will compete in the surgical setting with Sanofi-Aventis SA's top-selling injectable drug Lovenox, which is currently the standard treatment given to patients after major orthopaedic operations. Worldwide sales of Lovenox totalled 2.6 billion euros in 2007.

It also faces a newer competitor in the form of Boehringer Ingelheim's blood clot drug Pradaxa, which was approved in Europe in March.

Pradaxa 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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