UPDATE 2-U.S. FDA clears Bristol-Myers melanoma drug

* Drug is first to extend lives in advanced melanoma

* $820 million in global sales forecast for 2015

* Company’s shares gain 2 percent
(Adds FDA, analyst comments, background)

By Lisa Richwine

WASHINGTON, March 25 (Reuters) – Bristol-Myers Squibb
(BMY.N: Quote, Profile, Research) won U.S. approval on Friday for the first drug shown to
extend the lives of patients with a deadly form of skin
cancer.

Shares of the company rose 2 percent to $26.97 after the
Food and Drug Administration announced clearance of the drug
under the brand name Yervoy for patients with advanced
melanoma. The medicine’s generic name is ipilimumab.

A Thomson Reuters consensus forecast of four analysts calls
for ipilimumab sales to reach about $820 million in 2015.

The agency cleared the medicine for advanced melanoma
patients not yet treated for melanoma, or for patients who had
tried other options, FDA spokeswoman Erica Jefferson said.

In a company study, the intravenous medicine extended
survival of advanced melanoma patients by an average of four
months, a result seen as a major advance for a disease with
limited treatment options and a string of drug failures.

The FDA said it was requiring steps to inform doctors and
patients about risks of the drug “due to the unusual and severe
side effects,” including fatal autoimmune reactions.

Advanced melanoma is one of the deadliest cancers and can
quickly spread from the skin to internal organs, such as the
brain. Once melanoma spreads to other organs the average
survival is typically six to nine months.

The Bristol-Myers drug is an engineered version of a human
protein that targets CTLA-4, a molecule that acts like a brake
on the immune system. By gumming up the brake, the drug
unleashes the immune system to seek and destroy tumors.

Bristol-Myers is seeking new drugs to help overcome the
looming patent expiration on anti-clotting drug Plavix, which
it sells with Sanofi-Aventis (SASY.PA: Quote, Profile, Research).

Les Funtleyder, fund manager for Miller Tabak & Co, which owns
Bristol-Myers shares, said Yervoy’s sales could eventually top $1
billion annually.

“This is one of the things in the long run that will help
Bristol overcome the Plavix patent expiration,” he said.
(Reporting by Lisa Richwine and Bill Berkrot; Editing by Phil
Berlowitz)

UPDATE 2-U.S. FDA clears Bristol-Myers melanoma drug