Announcement no. 4/2007
To OMX Nordic Exchange Hørsholm, 6 March 2007
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
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.
For further information please contact:
LifeCycle Pharma A/S
Michael Wolff Jensen
Executive VP & CFO
Tel. +45 70 33 33 00
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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® 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.
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
| Source: Veloxis Pharmaceuticals A/S
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