UPDATE 3-Novartis, Astra win EU drug okays; Pfizer loses out

Fri Jun 22, 2012 8:56am EDT

* Novartis drugs Afinitor and Seebri Breezhaler recommended

* AstraZeneca's new antibiotic Zinforo also gets green light

* EMA rebuffs Pfizer/Protalix's Gaucher drug Elelyso (Adds detail on Elelyso and competitors)

By Ben Hirschler

LONDON, June 22 (Reuters) - Novartis and AstraZeneca won recommendations for important new drugs from European regulators on Friday, while rival Pfizer lost out.

The European Medicines Agency said its Committee for Medicinal Products for Human Use (CHMP) had endorsed Novartis's Afinitor for treating breast cancer, in addition to other tumour types, as well as another product for lung disease.

It also okayed AstraZeneca's new antibiotic Zinforo.

Pfizer, however, failed to secure backing for Elelyso, a new treatment for Gaucher disease that was approved in the United States in May. Elelyso was developed with Protalix Biotherapeutics and is a rival to both Sanofi's Cerezyme and Shire's Vpriv.

The London-based agency also recommended Revestive from Takeda's Nycomed unit for short bowel syndrome.

Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a couple of months.

The green light for Novartis's Afinitor in advanced breast cancer is a vote of confidence in a medicine that is expected to become a major seller for the Swiss drugmaker. Afinitor is already approved for other types of cancer such as kidney and a rare type of pancreatic cancer.

"This positive news de-risks around $500 million of peak European sales and gives greater confidence of U.S. approval due in the third quarter of 2012," said Deutsche Bank analyst Tim Race, who sees global peak annual sales for Afinitor of $1.7 billion in breast cancer alone.

Cancer is an increasingly important therapeutic area for Novartis, which faces stiff competition in the field from cross-town rival Roche, the world leader in oncology.

Seebri Breezhaler, the second Novartis drug to win a recommendation as a treatment for chronic lung disease, will be a smaller product, with Deutsche estimating peak sales at some $500 million. But it will play an important role as one part of a new combination treatment that Novartis is developing.

The once daily long-acting muscarinic antagonist, also known as NVA237, was licensed from British lung drug specialist Vectura.

For AstraZeneca, the success of Zinforo, an intravenous antibiotic for difficult-to-treat bacteria like methicillin-resistant Staphylococcus aureus (MRSA), is boost at a time when the company is struggling to bring new drugs to market.

It is also vindication of the group's strategy to continue investing in novel antibiotic research at a time when many others have left the field.

AstraZeneca secured rights to Zinforo, also known as ceftaroline, outside North America and Japan from Forest Laboratories in 2009. Forest launched ceftaroline under the under the trade name Teflaro in the U.S. last year. (Editing by Kate Kelland and David Holmes)

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