FDA Grants Meridian Laboratories Pre-IND Meeting for Captisol-Enabled Docetaxel in the Treatment of Cancer
Published: Oct 15, 2012
CHICAGO, Oct. 11, 2012 /PRNewswire-iReach/ -- Buffalo Grove, Illinois-based specialty-oncology drug development company, Meridian Laboratories, Inc is pleased to announce that the US Food and Drug Administration (FDA) has granted Meridian's request for a Type B Pre-Investigational New Drug (pre-IND) meeting to discuss its plan to commence clinical trials of ML061 as a treatment for various cancer indications. The meeting is scheduled for January 23, 2012
Meridian's lead product, ML061, is an IP-protected reformulation of Taxotere in Captisol that eliminates Polysorbate-80 and could remove the associated "Black Box" warnings and precautions. Meridian intends to seek approval with an abbreviated New Drug Application in the US with under SEC. 505(b)(2) [21 USC §355] New Drugs
Chairman Dr. William Zhao welcomed the response from the FDA. "We are pleased with this timely and positive response from the FDA. This is a significant step forward in the development of ML061." Meridian has assembled an accomplished biopharmaceutical development team including clinical and regulatory experts, Dr. G. Steven Geis and George Allen Hides. "Our proven team is already delivering outcomes." Dr. Geis, who is heading the clinical development of ML061, noted that Meridian Labs has a robust package of data to support regulatory submission through the US 505 (b)(2) regulatory pathway. "Following a successful pre-IND meeting, we expect to initiate a bioequivalence study in cancer patients in 2013."
About Meridian Labs
As the company's leading product, ML061 improves the formulation of Taxotere for cancer treatment, based on the same active ingredient docetaxel with a novel delivery method. By avoiding polysorbate 80 and ethanol, our objective is to show that ML061 improves the safety profile of Taxotere while maintaining its efficacy. We plan to bring the product to market as the top choice of chemotherapy for various cancer indications.
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SOURCE Meridian Laboratories, Inc