Ranbaxy Laboratories Limited (RLL) announced today that the company plans to market Zonisamide capsules for the treatment of epilepsy in the US market through a strategic partnership with Invagen Pharmaceuticals Inc. (Invagen) of Hauppauge, New York.
Invagen has received the US FDA approval for bio-equivalency and, therefore, a therapeutically equivalent Zonisamide to the listed drug Zonegran capsules, 25 mg, 50 mg, and 100 mg respectively.
The agreement with Invagen provides for products to be developed and submitted to the US FDA for approval, and for manufacturing in Invagen's US-based manufacturing facility. Ranbaxy Pharmaceuticals Inc. (RPI) will then commercialise the product under the Ranbaxy label to all classes of trade. Zonisamide capsules have total annualised sales of $170.3 million ($US, IMS-MAT: March 2006).
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
"The addition of Zonisamide capsules to our product mix through an alliance with Invagen reinforces our strategy to use inorganic means to grow our product pipeline, as well. Such partnerships with companies like Invagen, who have capabilities and competencies to develop bioequivalent generic products for the marketplace, are naturally beneficial to both organisations, while having a positive economic impact on the US healthcare system," according to Atul Malhotra, president of Ranbaxy Inc.
Jim Meehan, VP of sales and marketing at RPI offered the following comments: "We anticipate product availability to all classes of trade no later then the end of July once sufficient inventories are available to meet the needs of our customers. We are also pleased to see our partnership with Invagen come to fruition, and anticipate additional products materializing to fuel our market growth into the future."