Acrux (ASX:ACR) has announced the termination of its US licensing agreement with Eli Lilly for Axiron.
Termination of the license in the US is effective immediately and termination of license outside the US will be effective in 90 days. Global rights to the product will revert to Acrux.
According to the company in a statement, "Following an Advisory Committee meeting in 2014, the US Food and Drug Administration (FDA) required holders of new drug applications (NDAs) for approved testosterone products to conduct a well-designed Postmarketing Requirement (PMR) clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products. The trial would need to be conducted independently or through a consortium of NDA holders. The FDA requires a submission of the final PMR protocol by 5 September 2017. In the absence of a commitment to the PMR protocol, the FDA may take regulatory action against an NDA holder.
"On 23 August 2016, Acrux, and its licensee Eli Lilly and Company, appealed the decision by the United States District Court for the Southern District of Indiana, in which the Axiron formulation and axilla application patents granted by the US Patent and Trademark Office were held invalid. The Court of Appeals for the Federal Circuit in Washington, DC has scheduled the Axiron patents appeal proceedings for 5 October 2017."
While Acrux said it anticipates a decision from Federal Circuit within 6 months, generic versions of Axiron were launched in the US by Perrigo and Teva in July and August this year, along with an authorised generic marketed by Prasco.
"With the commercial uncertainty related to the impact of generics, the continued decline in the testosterone market, and the uncertain apportioned costs to participate in the PMR consortium of testosterone NDA holders, a request will be submitted to FDA to withdraw the NDA from the US market," it said.