* Panel voted 13-1 against Taltorvic in March
* Drug meant to keep sarcoma from getting worse
* Ariad shares down 2.4 pct in aftermarket
WASHINGTON, June 5 U.S. drugs regulators
rejected an experimental sarcoma medicine from Merck and
Ariad Pharmaceuticals on Tuesday, asking for more
clinical trials, Merck said.
The Food and Drug Administration issued a so-called
"complete response letter" for the injectable therapy, known
generically as ridaforolimus, after an advisory panel
recommended against approval earlier this year.
The drug, which would have been sold as Taltorvic, is meant
as a maintenance treatment for soft-tissue and bone sarcoma - or
tumors arising from the connective tissue - for people who have
already had at least four successful rounds of chemotherapy.
Soft-tissue sarcoma is a rare but aggressive form of cancer
that afflicted about 11,000 Americans last year and killed about
4,000 of them, according to the National Cancer Institute.
An advisory panel of outside experts to the FDA recommended
rejecting the medicine in March by a vote of 13 to 1 after data
linked the drug with serious side effects like hospitalization
or death, but showed it produced only small improvements in the
amount of time before cancer worsened.
Merck, which licensed all development and marketing rights
to the drug from Ariad, said it would work with the FDA to
figure out next steps.
"Merck remains confident in the potential of ridaforolimus,"
Dr. Eric Rubin, the company's vice president for clinical
research oncology, said in a statement.
Merck said it is still working on getting approval in
Europe, and is testing the drug in other cancers, including
lung, breast, endometrial and ovarian cancer.
Shares of Merck briefly slipped 0.6 percent to $37.27 in
after-market trading before recovering, while shares of Ariad, a
smaller company, fell 2.4 percent to $15.81.
Although Ariad's shares also fell after the panel vote in
March, some analysts said the medicine is of relatively minor
importance for the small biotech, which has two more major drugs
in the pipeline and would only get royalties from an approval of