Monday, March 26, 2007

Lilly's cancer drug Gemzar challenged by generics

Following a successful patent defense on Zyprexa, Lilly now faces challenges to Gemzar (gemcitabine, an injectible chemotherapy that treats several forms of cancer) from Sicor Pharmaceuticals Inc., Mayne Pharma Inc. and Sun Pharmaceutical Industries Inc. through challenges mounted via provisions of the Hatch-Waxman Act. The paragraph IV challengers argue that either the compound or method of use are obvious and can't be protected by a patent.

A spokesperson for Mayne (now owned by Hospira) stated "we will vigorously assert our rights to continue to help reduce the overall costs of health care through the introduction of high quality, less costly generic products." The fraction of drugs used which are generic has risen; generic drugs accounted for 56 percent of all U.S. prescriptions dispensed in 2005, a 211 percent increase over the past two decades, according to Pharmaceutical Research and Manufacturers of America.

A spokesperson for Lilly noted: Patent defenses are crucial because companies spend anywhere from $800 million to $1.2 billion to develop a drug and bring it to market.

IPBiz has noted elsewhere of patent issues in India pertaining to the cancer drug Gleevec (imatinib mesylate). As noted on cancerconsultants : Gleevec is a biological agent that is approved for the treatment of GIST as well as chronic myeloid leukemia (CML). Gleevec has activity in several biological pathways implicated in the development and/or expression of cancer. It tends to bind to targets within a cell and slows or stops the uncontrolled growth of the cancer cells with certain genetic mutations. Because the disease is often stabilized while a patient is being treated with Gleevec, researchers have questioned whether disease stabilization would be maintained if these patients were taken off Gleevec for a period. See also Blay J-Y, Le Cesne A, Ray-Coquard I, et al. Prospective multicentric randomized Phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 Year: The French Sarcoma Group. Journal of Clinical Oncology. 2007; 25: 1107-1113.


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