Meridian Laboratories, a Buffalo, Illinois based specialty-oncology drug development company, has announced that it has entered into a definitive agreement with Apobiologix, a part of the Apotex 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, chief executive officer 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 US 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.
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.
Apotex 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.