June 17 -- Merck KGaA is resuming tests of its experimental cancer vaccine Stimuvax in lung tumor patients after getting clearance from U.S. regulators.
Authorities have lifted the hold on two of the three late- stage clinical trials of the therapy, a global lung cancer trial and a trial that focuses on lung tumor patients in Asia, the Darmstadt, Germany-based maker of drugs and chemicals said in an e-mailed statement today. Merck said it remains in talks with the Food and Drug Administration about the future of the third trial, in breast cancer patients.
The FDA put Merck s Stimuvax trial program on hold in March after a patient with a blood malignancy developed a brain infection while taking the vaccine. The German drugmaker has said Stimuvax may generate as much as $1 billion in annual sales, boosting a portfolio of cancer medicines now led by Erbitux, which generated sales of 697 million euros ($855 million) last year. Oncothyreon Inc. licensed the vaccine to Merck KGaA.
This is another set of good news from the pharma division that had had some mishaps in recent months, Elmar Kraus, a Frankfurt-based analyst for DZ Bank AG, wrote in a note to clients.
Merck said June 8 it had resubmitted its FDA application for the experimental multiple sclerosis pill cladribine. The regulator rebuffed the initial application for the experimental pill in November, saying it was incomplete.
Authorities have lifted the hold on two of the three late- stage clinical trials of the therapy, a global lung cancer trial and a trial that focuses on lung tumor patients in Asia, the Darmstadt, Germany-based maker of drugs and chemicals said in an e-mailed statement today. Merck said it remains in talks with the Food and Drug Administration about the future of the third trial, in breast cancer patients.
The FDA put Merck s Stimuvax trial program on hold in March after a patient with a blood malignancy developed a brain infection while taking the vaccine. The German drugmaker has said Stimuvax may generate as much as $1 billion in annual sales, boosting a portfolio of cancer medicines now led by Erbitux, which generated sales of 697 million euros ($855 million) last year. Oncothyreon Inc. licensed the vaccine to Merck KGaA.
This is another set of good news from the pharma division that had had some mishaps in recent months, Elmar Kraus, a Frankfurt-based analyst for DZ Bank AG, wrote in a note to clients.
Merck said June 8 it had resubmitted its FDA application for the experimental multiple sclerosis pill cladribine. The regulator rebuffed the initial application for the experimental pill in November, saying it was incomplete.
