Merck received a Not Approvable action letter from the FDA regarding its NDA for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
In the FDA's letter, the agency also rejected the proposed trade name Cordaptive for MK-0524A. The company said at the appropriate time it expects to pursue the alternative trade name Tredaptive for use in the U.S.
Covance
1Q Revenues: $434.0 million (+15%)
1Q Earnings: $49.1 million (+26%)
Comments: Early development revenues were $202.0 million (+13%) led by growth of toxicology and chemistry services. Operating income increased 16% to $50.6 million. Late-stage development revenues were $210.4 (+18%). Growth was led by performances in central laboratory (+30%) due to an increase in kit volumes and clinical development as well as a strengthening of the Swiss franc. Operating income was $38.9 million (+33%). Backlog at March 31, 2008 grew 20% to $2.86 billion.
SGS Life Science Services has opened three new offices in Poland, Czech Republic and Romania as part of an initiative to expand its Global Clinical Development (GCD) services. The offices located in Prague, Warsaw, and Bucharest, respectively, will provide clinical trial monitoring services, study feasibility, and site selection, as well as support the regulatory aspects in these countries.
“The opening of the new offices addresses the request of many of our sponsors to conduct trials in Central and Eastern Europe in order to benefit from the vast pool of treatment-naïve patients, faster enrolment times, and the cost benefits these countries offer,” said Luc Braeken, vice president of Global Clinical Development. “Highly qualified and motivated investigators, low drop out rates of enrolled patients and the high quality of the clinical data are additional advantages of conducting trials in Central and Eastern Europe.”
The offices are staffed with teams experienced in conducting clinical trials in the pharmaceutical and CRO industry as well as in academia. The teams cover a wide range of therapeutic areas with special emphasis in CNS, infectious disease and cardiovascular disease. Also, SGS’ main office for GCD in Belgium will provide complementary services including project management, data management and statistics, regulatory affairs, and medical affairs.
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