Meridian Lab Announces Positive Outcome from Pre-NDA Meeting with FDA for ML141

Jan 26, 2016, 16:37 ET from Meridian Laboratories, Inc.

BUFFALO GROVE, Ill., Jan. 26, 2016 /PRNewswire/ -- Buffalo Grove, Illinois-based specialty-oncology drug development company, Meridian Laboratories, Inc. announced today the positive outcome of a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). The FDA has agreed with the Company's proposal to use the 505(b)(2) regulatory pathway for ML141, Meridian's proprietary liquid formulation of docetaxel injection for the treatment of multiple forms of cancer. The pre-NDA meeting was held in order for the company to acquaint FDA reviewers with the information to be submitted and to confirm the acceptance of Meridian's planned submission strategy and data package for the NDA submission. 

A 505(b)(2) application allows for a portion of the information required for a New Drug Application (NDA), such as safety and efficacy data of docetaxel, to come from completed studies previously conducted by other parties. This pathway can significantly reduce the costs and time required for drug development as compared to the traditional development path. Meridian has completed required studies in previously developed lyophilized formulation and will repeat some of the animal PK and in vitro studies to complete the NDA submission for the liquid formulation.

"We are gratified that the FDA has accepted our plan for the submission of the NDA for ML141 using the 505(b)(2) pathway," commented William Zhao, PhD MBA, Chief Executive Officer of Meridian Lab, "ML141 is the lead product in development to be submitted in a platform of drug compounds using our proprietary formulation approach. We are moving forward with the manufacture of the submission batches and completion of the NDA submission. With the approval of ML141, Meridian would be the only company having the unique formulation of docetaxel for multiple cancer indications."

About Meridian Laboratories, Inc.

Meridian's ML141 improves the formulation of Taxotere for cancer treatment, using the same active ingredient (docetaxel) with a novel delivery method.  Meridian's objective is to demonstrate that ML141 improves the safety profile of Taxotere while maintaining its efficacy. Meridian plans to develop the product as the top choice of chemotherapy for various cancer indications.

About AmeriTech Advisors

AmeriTech Advisors is an investment bank providing capital raising and strategic advisory services to growth companies with market capitalizations of between $25 million and $500 million. AmeriTech is working with Meridian Labs to connect with their network of investors for their submission.

 

 

SOURCE Meridian Laboratories, Inc.