Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Cephalon Inc.'s Actiq (oral transmucosal fentanyl citrate) [C-II], 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg cancer pain management treatment product.
Barr launched the product under the terms of a License Agreement previously granted to Barr by Cephalon in August 2004, pursuant to a Federal Trade Commission Order. The license grants Barr a non-exclusive right to sell a generic version of Actiq.
Under the obligations of the agreement, Cephalon is currently supplying Barr with fentanyl citrate manufactured under Cephalon's New Drug Application (NDA), which Barr then has the right to sell and market. Barr's Abbreviated New Drug Application (ANDA) is currently under active review at the US Food & Drug Administration (FDA).
"We are pleased that this patent settlement has enabled Barr to bring a more affordable, generic version of this critical pain management therapy to cancer patients earlier than otherwise would have been possible," said Bruce L. Downey, Barr's chairman and chief executive officer. "By launching this product, under the agreements with Cephalon, we are able to bring an additional option to patients that require this unique therapy."
Actiq is indicated for the treatment of breakthrough cancer pain in opioid tolerant patients and has current annual sales of approximately $590 million, based on IMS sales data for the twelve months ended July 2006.
Barr filed its ANDA for Actiq containing a paragraph IV certification with the FDA in October 2004. The company received notification of the application's acceptance for filing in December 2004. Following receipt of the notice from the FDA, Barr notified Cephalon, the NDA holder and patent owner. On January 20, 2005, Cephalon filed suit in the US District Court in Delaware to prevent Barr from proceeding with the commercialization of its product. In February 2006, Barr and Cephalon entered into an agreement to settle the patent infringement dispute and filed a dismissal with the Court to conclude the litigation between the parties regarding Actiq.
Under two agreements with Cephalon, Barr was provided a license for Actiq that was due to become effective on the earliest to occur of the following: (i) FDA approval of Cephalon's Fentora product; (ii) September 5, 2006, if Cephalon did not receive an extension of exclusivity based upon the completion of paediatric studies for Actiq; or (iii) December 6, 2006. On September 25, 2006 Cephalon received approval for its Fentora product. In addition, Cephalon has not received the paediatric extension for Actiq, resulting in Barr's license having become effective as of September 5, 2006. As a result, Barr has launched its generic Actiq product.