In this file photo from Nov. 16, 2010, Rensselaer County Executive Kathy Jimino, left, and Daniel Van Plew, Regeneron's senior vice president and general manager, industrial operations and product supply, right, break ground on the pharmaceutical company's expansion in East Greenbush. (J.S. Carras/The Record)
EAST GREENBUSH ?The state's largest pharmaceutical company, Regeneron Pharmaceuticals, Inc., announced Monday morning that a drug to aid treatment of metastatic colorectal cancer in adults has been approved for marketing in the European Union. The approval is only for patients in whose bodies the disease has resisted certain other treatments.
The drug, brand named ZALTRAP, was approved by the European Commission following the findings of a randomized trial of 1,226 patients from patients in several countries and a recommendation by a panel of physicians from the European Medicine Agency.
?It was expected, not guaranteed, but expected,? said Stephen Dworkin, a spokesperson for Regeneron.
The trials found the drug, given as part of a chemotherapy treatment, extended the median survival rate for patients that had previously been treated with another method by six weeks, from around 12 months to around 13.5 months, an 18 percent risk reduction.
After conducting research into the drug for more than a decade, it was approved in August 2012 for sale by the Food and Drug Administration in the United States and is now available for prescription. In the U.S., ZALTRAP has been commercialized by Paris-based pharmaceutical company Sanofi, formerly Sanofi-Aventis, which will also bring the product to European markets.
The drug will only be available in some European Union countries immediately. Certain countries require price negotiations between companies looking to sell a new drug, such as Sanofi, and the government. In single-payer systems such as the EU, the government in each country is often the major buyer.
Colorectal cancer is the most common cancer in both men and women and is the second leading cause of death from cancer. There were 436,000 new cases of colorectal cancer diagnosed last year and 212,000 deaths from the disease, according to the Annuals of Oncology.
Development and production of the drug took place over ten years at Regeneron's production facility on the State University at Albany's East Campus along Columbia Turnpike. There, the company has about dozen products in clinical development in addition to three that are approved and marketed, including ZALTRAP and EYLEA.
Regeneron employs 540 people on the East Greenbush campus and expects to grow its workforce by more than 840 with the addition of two new facilities. One of those two facilities, a new office building, is currently under construction, Dworkin said.
In early December, Bayer Healthcare submitted an application to allow another of Regeneron's products, EYLEA, to be marketed in the European Union. The drug is an injection for the treatment of macular edema caused by central retinal vein occlusion. The application is undergoing review.
Source: http://www.troyrecord.com/articles/2013/02/06/news/doc5111f869d0b20588069423.txt
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