King: FDA may require another trial for Altace to treat pediatric hypertension

By E. Janene Geiss

Philadelphia, March 24 - King Pharmaceuticals, Inc. said Friday that the Food and Drug Administration has informed the company that the data from its completed Altace trial for the treatment of pediatric hypertension submitted in support of its supplemental New Drug Application are insufficient.

The company said it believes that, subject to additional discussions with the FDA, it may be necessary to conduct a second clinical trial in order to receive an additional six months of exclusivity beyond patent expiry for the company's Altace (ramipril) product, according to a company news release.

In light of this denial, the company said it plans to have further discussions with the FDA and provide additional supportive analyses.

If necessary, the company said it also intends to pursue an additional clinical trial and meet with the FDA to reach agreement on the design of that trial.

The company said it believes it can obtain an additional six months of market exclusivity for Altace as long as it conducts the additional trial, reports results and meets FDA requirements by the third quarter of 2008.

The trial was started in response to the FDA's written request for additional information regarding Altace that may produce health benefits in pediatric populations. This request was issued in accordance with the Modernization Act of 1997.

Altace is the leading branded ACE inhibitor with multiple indications including hypertension and reducing risk of death in congestive heart failure patients.

King is a Bristol, Tenn., pharmaceutical company that seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.

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