* Cos expect to file US and EU marketing approval in H2
* Regeneron shares rise 12 pct in after-market trade
(Adds background on trial design in paragraphs 5-10)
April 26 (Reuters) - Sanofi-Aventis and Regeneron Pharmaceuticals Inc said their experimental drug Zaltrap extended survival in colon cancer patients in a late-stage trial, sending Regeneron shares up 12 percent in extended trading.
Zaltrap, also known as aflibercept, was being tested in combination with chemotherapy, as a second-line treatment in metastatic colorectal cancer patients.
The main goal of the trial was extending overall survival, the gold standard for cancer drug trials.
'Based upon these positive findings, we and Sanofi-Aventis plan to submit regulatory applications for marketing approval to the U.S. Food and Drug Administration and the European Medicines Agency in the second half of the year,' Regeneron Chief Scientific Officer George Yancopoulos said.
The study had enrolled 1,226 patients with metastatic colorectal cancer, who have failed one platinum-based therapy.
The companies said they plan to present the full data at an upcoming medical meeting.
Worldwide, colorectal cancer is the third most commonly diagnosed cancer in males and the second most in females, with more than 1.2 million new cases diagnosed in 2008.
Aflibercept works by blocking a protein called VEGF that tumors use to build blood vessels capable of supplying themselves nutrients.
In March, Sanofi and Regeneron suffered a setback when their drug aflibercept failed to show survival benefit in patients with lung cancer in a late-stage trial.
Sanofi and Regeneron are currently co-developing the drug as a treatment for patients with advanced cancer.
Regeneron shares rose as much as 12 percent in trading after the bell. They closed at $52.14 on Tuesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Anthony Kurian and Gopakumar Warrier) Keywords: REGENERON/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Regeneron shares rise 12 pct in after-market trade
(Adds background on trial design in paragraphs 5-10)
April 26 (Reuters) - Sanofi-Aventis and Regeneron Pharmaceuticals Inc said their experimental drug Zaltrap extended survival in colon cancer patients in a late-stage trial, sending Regeneron shares up 12 percent in extended trading.
Zaltrap, also known as aflibercept, was being tested in combination with chemotherapy, as a second-line treatment in metastatic colorectal cancer patients.
The main goal of the trial was extending overall survival, the gold standard for cancer drug trials.
'Based upon these positive findings, we and Sanofi-Aventis plan to submit regulatory applications for marketing approval to the U.S. Food and Drug Administration and the European Medicines Agency in the second half of the year,' Regeneron Chief Scientific Officer George Yancopoulos said.
The study had enrolled 1,226 patients with metastatic colorectal cancer, who have failed one platinum-based therapy.
The companies said they plan to present the full data at an upcoming medical meeting.
Worldwide, colorectal cancer is the third most commonly diagnosed cancer in males and the second most in females, with more than 1.2 million new cases diagnosed in 2008.
Aflibercept works by blocking a protein called VEGF that tumors use to build blood vessels capable of supplying themselves nutrients.
In March, Sanofi and Regeneron suffered a setback when their drug aflibercept failed to show survival benefit in patients with lung cancer in a late-stage trial.
Sanofi and Regeneron are currently co-developing the drug as a treatment for patients with advanced cancer.
Regeneron shares rose as much as 12 percent in trading after the bell. They closed at $52.14 on Tuesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Anthony Kurian and Gopakumar Warrier) Keywords: REGENERON/ (anand.basu@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: anand.basu.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.