Meridian Lab and Apobiologix Enter into a Definitive Agreement for Development of Docetaxel Injection

CHICAGO, Feb. 1, 2017 /PRNewswire/ -- Meridian Laboratories, Inc., a Buffalo, IL based specialty-oncology drug development company, announced today that it has entered into a definitive agreement with Apobiologix, a part of the Apotex Inc. group, to develop and market a one-vial liquid improved formulation of docetaxel injection for the treatment of multiple forms of cancer. The agreement includes the possibility for co-development and marketing of future products between Meridian and Apobiologix, which has a strong oncology pipeline.

Under the terms of agreement, Apobiologix will pay a combination of milestones and royalties to Meridian. "The availability of this improved formulation of docetaxel offers an important benefit to patients," stated William Zhao, PhD MBA, CEO and Chairman of Meridian, "Apobiologix expertise in the oncology arena will accelerate the development of our products to fulfill unmet needs for patients and their physicians."

The news comes following a positive outcome from a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) where the FDA agreed with Meridian's proposal to use the 505(b)(2) regulatory pathway for the New Drug Application (NDA) submission of docetaxel injection formulation, which allows for a portion of the information required for a 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.

About Meridian Laboratories, Inc.
Meridan Laboratories, Inc. was established to develop novel drug therapies intended to deliver safe and effective treatment to oncology patients, while limiting toxic side effects. The company's objective is to demonstrate that its docetaxel product improves the safety profile of the current treatment while maintaining its efficacy. Meridian is currently developing a pipeline of drug therapies, including extensions of docetaxel.

About Apobiologix
Apobiologix is a leader in the field of biosimilar development. As a division of ApoPharma USA, Inc., and a part of the Apotex, Inc. group.  Apobiologix is focused on developing innovative biologic products in oncology and hematology, aimed at providing patients and providers with high-quality medicines.

About Apotex Inc.
Apotex Inc. was founded in 1974 and is the largest Canadian-owned pharmaceutical company. The company currently employs over 11,000 people in research, development, manufacturing and distribution facilities worldwide. The Canadian operations of the Apotex Group of Companies has over 6,000 employees. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year. The company's pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe.

Although the company's own business is developing and manufacturing generic pharmaceuticals, it has diversified into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

SOURCE Meridian Laboratories, Inc.