2014

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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