Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

Date : 06/27/2008 @ 8:00AM
Source : PR Newswire
Stock : Merck & CO., (MRK)
Quote : 26.23  0.02 (0.08%) @ 8:00PM
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Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

KENILWORTH and WHITEHOUSE STATION, N.J., June 27 /PRNewswire-FirstCall/ -- Schering-Plough Corp. (NYSE:SGP) and Merck & Co., Inc. (NYSE:MRK) announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.

The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture, which was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast. This action has no impact on the business of the Merck/Schering-Plough cholesterol joint venture.

The U.S. Food and Drug Administration (FDA) issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.

As a result of the termination of the respiratory joint venture, Schering- Plough expects to receive payments totaling $105 million from Merck as specified in the joint venture agreements which Schering-Plough will recognize over the remaining three quarters of 2008.

DATASOURCE: Schering-Plough Corp.; Merck & Co., Inc.

CONTACT: Media: Lisa Ellen, Schering-Plough Corp., +1-908-298-7128,

+1-201-506-0420 (cell) or Skip Irvine, Merck & Co., Inc., +1-267-305-5397,

+1-267-218-4477 (cell); Investors: Janet Barth or Joe Romanelli,

Schering-Plough Corp., +1-908-298-7436 or Eva Boratto, Merck & Co., Inc.,

+1-908-423-5185

Web site: http://www.schering-plough.com/

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