FDA Rejects Ariad, Merck's Sarcoma Drug Ridaforolimus

FDA Panel Backs Merck Insomnia Drug Suvorexant, But At Lower Doses

Merck Announces $5 Bln Accelerated Share Repurchase

Merck To Present At UBS Global Conference; Webcast At 10:30 AM ET

Trade MRK now with

6/5/2012 6:45 PM ET

Merck & Co. Inc. (MRK: Quote) said Tuesday that the U.S. Food and Drug Administration has rejected the new drug application for ridaforolimus, an investigational oral mTOR inhibitor under development for maintenance treatment for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.

The FDA stated in its complete response letter that it cannot approve the application in its present form and that additional clinical trial(s) would be needed to further assess safety and efficacy of the drug, according to Whitehouse Station, New Jersey-based Merck.

"Merck remains confident in the potential of ridaforolimus," said Eric Rubin, vice president, Clinical Research Oncology, Merck. "We will continue to work closely with the FDA to define potential paths forward for this investigational therapy."

Merck also said it is in ongoing talks with health authorities in Europe and other countries as part of their application procedures for ridaforolimus and is studying the drug in combination with other mechanisms in several tumor types.

Merck is responsible for the development and commercialization of ridaforolimus in oncology as part of an exclusive license agreement with Ariad Pharmaceuticals, Inc (ARIA: Quote).

The FDA's rejection of the NDA for ridaforolimus was on expected line. In March, an FDA advisory panel had voted 13-1 recommending against approval of the drug.

A sarcoma is a type of cancer that develops from certain tissues, like bone or muscle. There are 2 main types of sarcoma: bone sarcomas and soft tissue sarcomas. According to the University of California, San Francisco, about 2,500 new cases are diagnosed annually.

If approved, ridaforolimus would compete with GlaxoSmithKline Plc's (GSK, GSK.L) Votrient, which received FDA approval in April for expanded use on patients with soft-tissue sarcomas who have had chemotherapy.

Merck shares closed Tuesday's regular trading session at $37.50, up 4 cents, and is currently gaining 7 cents in after hours trading. Ariad shares are currently losing 1.67% in after hours trading after closing the day's regular trading session at $16.20, up 57 or 3.65%.

To receive FREE breaking news email alerts for Merck & Co Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

More Breaking News

<<Previous 83 Articles

Editors Pick

U.S. Durable Goods Orders Rise 3.3% In April, More Than Expected

After reporting a sharp drop in new orders for manufactured durable goods in the previous month, the Commerce Department released a report on Friday showing that durable goods orders rebounded by more than anticipated in the month of April. The report said durable goods orders surged up by 3.3 percent in April after tumbling by a revised 5.9 percent in March.

Stocks May Move Lower As Upbeat Data Raises Fed Concerns - U.S. Commentary

After showing a substantial recovery over the course of the previous session, stocks are likely to come under pressure in early trading on Friday. The major index futures are currently pointing to a lower open for the markets, with the Dow futures down by 42 points.

Mailbox Now Comes To IPad

The popular e-mail management app Mailbox, developed by Orchestra Inc., has been updated to be compatible with Apple's iPad. Orchestra disclosed the news of the update through its official blog. "You asked, we listened. Mailbox is now available for iPad, so you can swipe your way to inbox zero on all your iOS devices," Orchestra's brief blog read.