UPDATE 1-Roche, OSI win U.S. approval for wider Tarceva use

* First oral therapy for lung cancer maintenance

* Tarceva had 2009 sales of $1.2 billion

WASHINGTON, April 16 (BestGrowthStock) – Roche Holding AG (ROG.VX: )
and OSI Pharmaceuticals (OSIP.O: ) won U.S. approval on Friday to
promote earlier use of the blockbuster lung cancer pill
Tarceva.

The Food and Drug Administration cleared Tarceva for
patients with lung cancer that remained stable after
chemotherapy. The two companies co-market the drug.

“We hope this approval will help more people fight the
leading cause of cancer death in the United States,” Hal
Barron, chief medical officer at Roche’s Genentech unit said in
a statement. “Tarceva is the first oral maintenance option for
people with advanced NSCLC (non-small cell lung cancer) who
want to continue treating their cancer before it grows or
spreads again.”

Tarceva, which had $1.2 billion in sales last year, already
was approved for treating lung cancer that had gotten worse
following at least one chemotherapy regimen.

Japan’s Astellas Pharma Inc (4503.T: ) has made a hostile
takeover bid for OSI. Astellas recently extended a $3.5 billion
tender offer to April 23.

OSI receives royalties on sales of Tarceva, which is also
approved for pancreatic cancer. The Melville, New York-based
company reported $358.7 million in Tarceva-related revenue last
year — more than 80 percent of its total revenue — and net
income of $75.9 million.

In December, an FDA advisory panel voted 12-1 against
recommending approval of the wider use for Tarceva. Panel
members who were opposed said the drug’s benefit was modest in
the earlier setting.

Tarceva improved survival by about one month compared to a
placebo when given to stable patients. But both Tarceva and
another drug, docetaxel, have been shown to boost survival of
lung cancer patients by about three months when started after
their disease has advanced.

The drug’s generic name is erlotinib.

Tarceva will compete with Eli Lilly and Co’s (LLY.N: )
Alimta, which already is approved for the earlier lung cancer
use.

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(Reporting by Lisa Richwine and Deena Beasley; editing by
Carol Bishopric)

UPDATE 1-Roche, OSI win U.S. approval for wider Tarceva use