LifeCycle Pharma Announces Approval of its LCP-FenoChol product Will Not be Subject to a So-Called 30-month Stay Under the Hatch-Waxman Act
Summary: Regulatory approval of LCP-FenoChol will not be subject to a
so-called 30-month stay under the Hatch-Waxman Act
HORSHOLM, Denmark, March 6 /PRNewswire/ -- LifeCycle Pharma A/S (OMX:LCP) announced today that within the 45-day period under the Hatch-Waxman Act the company has not received notice of any patent infringement lawsuits regarding the company's Paragraph IV certification for LCP-FenoChol filed with the Food and Drug Administration (FDA) and sent to relevant Orange Book patentees and NDA holders. The company's New Drug Application (NDA) for LCP-FenoChol will therefore not be subject to a so-called 30-month stay under the Hatch-Waxman Act. Assuming regulatory approval, the company expects LCP-FenoChol to be ready for market launch in the United States in early 2008. About LCP-FenoChol LCP-FenoChol (containing 120mg/40mg active substance) is being developed to become an improved fenofibrate product with the lowest and most effective marketed dose without food effect. According to the American Heart Association (AHA), up to 34.5 million people in the United States suffer from high cholesterol levels in the blood, and some of the biggest sub-populations have too high triglycerides levels, including patients with metabolic syndrome, mixed dyslipidemia and diabetes. Fenofibrate has proven to be very effective at lowering triglyceride concentrations and increasing high density lipoprotein ("HDL" or good cholesterol). In addition, it has a superior side effect profile compared with alternative drugs. In 2006, sales of all fenofibrate drugs were approximately USD 1.7 billion world-wide, an increase of 16% over 2005 (source: IMS). LifeCycle Pharma's NDA under Section 505(b)(2) to produce and market LCP-FenoChol in the US was accepted for regulatory review by the FDA in December 2006. About LifeCycle Pharma: LifeCycle Pharma is an emerging pharmaceutical company with a broad and late stage product pipeline in therapeutic areas of cholesterol management, hypertension and organ transplant. LifeCycle Pharma's most advanced product has been filed with the U.S. FDA and is expected to enter the US market in the first quarter of 2008. LifeCycle Pharma's product candidates are proprietary and designed to improve the quality of existing drugs by enhancing the release and absorption of drugs in the human body. LifeCycle Pharma's proprietary technology platform, MeltDose(R) technology, offers lower dosing, reduced side effects and improved safety and patient compliance as well as reduced product development time and production costs. LifeCycle Pharma has formed several partnerships with major pharmaceutical companies and is clinically developing product candidates within a number of areas, including cholesterol management, hypertension and organ transplant. LifeCycle Pharma is listed on the OMX Nordic Exchange under the trading symbol (LCP). Please visit www.lcpharma.com for further information about LifeCycle Pharma A/S.
SOURCE LifeCycle Pharma
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