Mayne Group Limited, a leading private health care provider, has agreed, through its wholly-owned subsidiary Faulding Pharmaceutical Co., to acquire the rights to the generic injectable pharmaceutical, propofol, including patent rights for this anaesthetic product, and the rights to fluconazole, an injectable anti-fungal product, from Baxter Healthcare Corporation.
These products are both currently under development and have significant market potential in the USA. Baxter acquired the rights to these pipeline products through its acquisition of Wyeth's ESI Lederle division. The USA Federal Trade Commission requested that Baxter divest the propofol assets as a condition of approving the purchase of ESI.
Mayne Group managing director and CEO, Stuart James, said that the acquisition is in line with the group's strategic focus in its pharmaceuticals business on injectable hospital products in attractive markets.
Payment to Baxter for these products is structured on milestone achievements in relation to regulatory filing and approval, as well as commercialization. Commercial sales are anticipated to commence in 2004 for fluconazole and in 2005 for propofol.
The filing of the propofol ANDA (Abbreviated New Drug Application), which is under review by the Federal Drug Authority, resulted in a patent suit by the product innovator, Astra Zeneca. Mayne is confident of successfully defending the patent suit, however, the cost arising from this action has been factored into the consideration agreed for these assets.
The transaction is subject to FTC approval and is expected to be completed in early 2003.