* 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 Novartis and
AstraZeneca won recommendations for important new drugs
from European regulators on Friday, while rival Pfizer
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
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
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
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)