Patents

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

Published in Healthcare Mergers, Acquisitions and Ventures Week, March 24th, 2007

LifeCycle Pharma A/S (OMX:LCP) announced 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.

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Source: Healthcare Mergers, Acquisitions and Ventures Week (2007-03-24)

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