May 28, 2008 - LifeCycle Pharma A/S (OMX:LCP) today announced the successful completion of pilot studies for LCP-Feno, a product for the treatment of dyslipidemia which is being developed in collaboration with Sandoz Inc. LCP-Feno is designed to be an AB-rated, substitutable version of Tricor(R) 145 mg, currently marketed in the US by Abbott under the name Tricor(R) and in Europe by Solvay S.A. under the name Lipanthyl (R). In collaboration with Sandoz, LifeCycle Pharma is currently preparing for the initiation of pivotal studies to complete all the necessary requirements for a US ANDA filing.
"We are extremely pleased to have shown bioequivalence of LCP-Feno and Tricor(R) in this pilot study," said Dr. Michael Beckert, LifeCycle Pharma's Chief Medical Officer and Executive Vice President. "This is another important milestone for the company, and a clear validation of the breadth of application as well as versatility of the MeltDose(R) technology. The next step will be to prepare for pivotal pharmacokinetic studies to confirm these results."
The details can be read here.
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