Amerigen Pharmaceuticals Inc., a subsidiary of Amerigen Pharmaceuticals Limited has filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Bystolic with the US Food & Drug Administration (FDA) and is seeking approval to market its nebivolol hydrochloride tablets prior to expiration of US Patent 6,545,040.

On March 13, Forest Laboratories and Janssen Pharmaceutica filed suit for patent infringement against Amerigen in the District of Delaware.

Based upon available information, Amerigen believes that it may be a first applicant to file an ANDA for a generic version of Bystolic containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA for nebivolol hydrochloride tablets be approved by the FDA, Amerigen believes that its product may be entitled to 180 days of generic marketing exclusivity.

For the twelve months ending December 31, 2011, Forest reported US net sales of Bystolic of approximately US$ 324 MM.

Bystolic is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. Its focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market.