Par Pharmaceutical Inc has entered into an agreement with Bristol-Myers Squibb Company to license the Megace trade name to be used in a potential new product being developed by Par. The product, if successfully developed, would be a line extension of Par's megestrol oral suspension business and filed as a 505(B)(2). Under the terms of the agreement, Par has also provided funding to support active promotion of Megace O/S (megestrol acetate oral suspension) brand during the remainder of 2003 and throughout 2004 to help retain brand equity and awareness among physicians.
Megace O/S is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immune deficiency syndrome (AIDS).
Par currently markets megestrol oral suspension, the generic version of Megace O/S, which it launched in July 2001. In 2002, Par's unique formulation of megestrol oral suspension achieved sales of $83 million.
Additionally, Par is currently in litigation with both Roxane Labs and Teva Pharmaceuticals for infringement of Par's patents. Par will aggressively defend its intellectual property rights.
Based upon these events and the competitive information currently available, the Company anticipates only a modest decline in its generic megestrol oral suspension product sales during the second half of 2003. The sales decline will depend upon several factors, including but not limited to, the success of Megace O/S marketing efforts as well as competitive factors.