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Berlex' Angeliq Is "Approvable"; More Manufacturing Data Needed

This article was originally published in The Pink Sheet Daily

Executive Summary

The company anticipates a 2005 approval for the hormone replacement therapy for the lowest dose submitted. The firm is also touting a potential antihypertensive effect with Angeliq for higher doses.

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Berlex' Angeliq Approved, Will Launch In Mid-2006

The hormone therapy launch will be delayed to allow for physician education and to give the company time to consider internal resource issues as well as near-term pipeline opportunities, Berlex said.

Berlex' Angeliq Approved, Will Launch In Mid-2006

The hormone therapy launch will be delayed to allow for physician education and to give the company time to consider internal resource issues as well as near-term pipeline opportunities, Berlex said.

Angeliq Hormone Therapy Action Date Expected In Fourth Quarter

A late 2005 approval would come nearly four years after Schering AG filed the Angeliq NDA. Expected fourth quarter action date indicates company will submit CMC data by June.

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