There has been a delay in the approval process for Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA) first biogeneric drug in the US. The US Food and Drug Administration (FDA) has requested additional information concerning the company's drug Neutroval, designed to boost white blood cell production in patients undergoing chemotherapy.
Teva's drug is biogeneric, or biosimilar, meaning that it is a generic version of an existing biological drug. It is based on biological drug Neupogen, produced originally by Amgen, and having sales in the hundreds of millions of dollars annually. However, in the absence of appropriate legislation in the US for approval of biogeneric drugs, in late 2009, Teva applied to the FDA for approval on the new biological drug track, known as a Biologic License Application (BLA).
Teva issued an announcement on the letter received from the FDA, and said it was examining the matter and would "work with the FDA to determine the appropriate next steps regarding this application." Teva added that the FDA did not require it to perform additional clinical trials. In Europe, the drug is already for sale in several countries, under the brand TevaGrastim.
Another announcement from Teva at the end of last week concerned its collaboration with Canadian company OncoGenex. A few months ago, Teva invested approximately $60 million in joint development and in shares of the Canadian company. The two are developing custirsen as a treatment for prostate cancer.
Now, the companies have announced SYNERGY, a global Phase 3 trial, and the second of three Phase 3 trials to be initiated under their global collaboration and license agreement to develop and commercialize custirsen.
The SYNERGY trial is a randomized, controlled, global Phase 3 trial to be conducted in approximately 125 cancer centers and with designated recruitment of 800 men with metastatic CRPC who have disease progression and require first-line docetaxel/prednisone chemotherapy.
"The prostate cancer landscape is rapidly evolving with the introduction of new therapies to improve patient outcomes,” said Dr. Johann de Bono, the co-Principal Investigator of the trial, the Institute of Cancer Research and The Royal Marsden Hospital, London. “If validated in these two Phase 3 trials, custirsen could offer a unique benefit to patients for prolonged survival and improved quality of life, both of which are key considerations in the treatment of the disease.”
Custirsen has received Fast Track designation from the FDA.
Published by Globes [online], Israel business news - www.globes-online.com - on October 3, 2010
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