IMGN ImmunoGen Inc

Roche Holding AG's (ROG.VX) hopes for a speedy approval of a new breast cancer drug were dashed Friday after U.S. regulators rejected a priority review of T-DM1, adding another item to the growing list of drug development delays and setbacks at the Swiss pharma giant.

The rejection by the U.S. Food and Drug Administration means that Roche will have to finalize an ongoing phase III study before it can file for approval for the medicine, something it hopes to do in mid-2012. Had the FDA granted accelerated approval, analysts had expected Roche to launch the drug early next year.

"We firmly believe in the potential of T-DM1 ... and remain fully committed to its ongoing development," said Hal Barron, Roche's head of global development and chief medical officer. Roche had filed T-DM1 for priority review in early July, raising analysts' hopes the medicine could help sooner than expected to replace Roche's blockbuster drug Herceptin, which will lose patent protection in years to come.

While the setback of Roche's T-DM1 only leads to the drug's approval being delayed, analysts said they were still disappointed about the FDA decision. "It's not a big setback, but it doesn't help sentiment after the recent development disappointments," said Silvia Schanz, analyst at Bank Vontobel.

"Although the revenue implications are minimal...this setback raises further questions on the late stage pipeline at Roche," said Karl-Heinz Koch of brokerage Helvea.

Roche has had a string of setbacks recently, including its experimental diabetes medicine taspoglutide, whose approval filing had to be delayed due to safety concerns. Other blows include the discontinuation of experimental drug ocrelizumab for treating patients suffering from rheumatoid arthritis. Roche's cancer drug Avastin also failed in late-stage prostate cancer trials. Earlier this month, U.K. regulators rejected Roche's Avastin in bowel cancer on grounds of cost effectiveness.

Shares of Roche, which have lost more than 20% this year due to growing pipeline concerns and fears that world-wide austerity programs will hurt its sales and profit margins in the years to come, traded lower in early trade. At 1431 GMT, they were up 0.6 Swiss francs, or 0.4%, at CHF137.7 in an overall firmer market.

Analysts, however, noted that Roche's recent disappointments were manageable because, unlike some of its competitors, the Swiss company doesn't face immediate patent losses and thus has more time to develop new drugs. Recent takeovers and licensing deals should also help Roche going forward, they said, noting the FDA's rejection of T-DM1 was due to technical rather than fundamental reasons.

Roche said the FDA's rejection of priority review was due to the fact that the T-DM1 trials failed to meet the standard for accelerated approval "because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population." The priority filing of T-DM1 was partly due to the fact that the drug works well with breast cancer patients who have a high level of protein HER2.

T-DM1, should it be approved, could become a blockbuster drug with net peak sales of around CHF2 billion or more, according to analysts' estimates. Unlike traditional cancer therapies, T-DM1, which is also known as trastuzumab-DM1, targets only cancerous cells as the medicine links a monoclonal antibody and a cytotoxic. In chemotherapy, healthy cells are also destroyed, increasing chances for complicated side effects. The drug was developed by Roche unit Genentech and Immunogen Inc. (IMGN).

-By Goran Mijuk, Dow Jones Newswires; +41 43 443 80 47; goran.mijuk@dowjones.com

ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jun 2024 to Jul 2024

ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Jul 2023 to Jul 2024