A pilot bioequivalence study has been completed and scale up will begin shortly. Elite will manufacture the product and Pliva will market and sell the drug. The development costs will be paid by both companies and the profits shared equally.
Bernard Berk, chairman and CEO of Elite, said: “We are very pleased to have this relationship with Pliva Inc., a well known and highly regarded company in the generic drug industry. This controlled release product represents another step in building our pipeline at Elite and is Elite’s third product development agreement this year.”
Elite has one product currently being sold commercially and a pipeline of six drug products under development in the therapeutic areas that include pain management, allergy, cardiovascular and infection. According to Elite, the addressable market for the company’s current pipeline of products exceeds $6 billion.