European Drug Watchdog Supports New Pill by Bayer

By REUTERS
LONDON, 28 july 2008— Bayer’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.
The drug watchdog said on Friday that its Committee for Medicinal Products for Human Use had backed Xarelto for the prevention of blood clots after hip or knee surgery.
Recommendations for marketing approval by the committee are normally endorsed by the European Commission within a couple of months.
Bayer, which estimates that global 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, a member of the Bayer HealthCare executive committee, responsible for product development.
Bayer shares rose 3.6 percent, to $87.50, in New York trading 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.
Citi analysts said progress with Xarelto showed Bayer was making a transition from a reorganization play — after its 17 billion euro acquisition of Schering in 2006 — to a growth story driven by a maturing pipeline of new medicines.
Outside Europe, regulatory filings for Xarelto have been submitted in more than 10 countries, including Canada and China. It is expected to be submitted for approval soon 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.