Endo International is terminating commercialization agreements with a pair of partners covering urology products as the company refocuses its U.S. branded drug portfolio toward pain treatments.

Through subsidiaries Auxilium Pharmaceuticals and Endo Ventures Limited, Endo said in a Form 8-K regulatory filing yesterday, it sent written notice to VIVUS that it will end the companies' License and Commercialization Agreement, and a related commercial supply agreement, effective June 30, 2016.

The license agreement gives Auxilium—which Endo acquired for $2.6 billion in a deal completed in January 2015—the exclusive right to commercialize VIVUS’s STENDRA® (avanafil) for any urological disease or condition in humans, including male erectile dysfunction, in the U.S. and Canada and their territories.

Under the agreement, signed in 2013, VIVUS was eligible for up to $300 million based on regulatory and sales milestones, including a $30 million up-front “licensing fee” and a $15 million payment tied to a potential label amendment regarding onset-of-action, plus tiered royalties on aggregate annual net sales.

VIVUS agreed to exclusively supply and manufacture STENDRA, directly or through subcontractors, with Endo agreeing to pay VIVUS its manufacturing cost plus a percentage markup per unit of STENDRA.

VIVUS said this afternoon it intends to reacquire the U.S. and Canadian commercial rights for STENDRA.

“We remain confident in STENDRA's long-term prospects,” VIVUS CEO Seth Fischer said in a statement. “We are in the process of evaluating ways for maximizing the value of STENDRA and expect to make an announcement by the end of the first quarter of 2016 with our decision.”

Separately yesterday, another Endo subsidiary, Endo Ventures Bermuda Limited, sent Acerus Pharmaceuticals written notice that it will end the companies’ License, Development, and Supply Agreement, also effective June 30, 2016. Endo acquired from Acerus exclusive commercial rights in the U.S. and Mexico of NATESTO™ (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism.

Under the Acerus agreement—signed in 2014 by Endo and Acerus under its former name Trimel Pharmaceuticals—Trimel was eligible for $25 million up front, up to $165 million based on regulatory and sales milestones, and a $5 million prepaid inventory deposit upon closing of the deal.

“While we are disappointed with Endo’s previously announced strategic business decision to realign their U.S. branded resources from urology retail to their pain franchise, we are fully committed to the continued success of NATESTO in the U.S.,” Acerus President and CEO Tom Rossi said today in a statement issued by his company.

“Our immediate focus is on finding a new NATESTO partner in the U.S.,” Rossi added. “We are encouraged by the positive physician and patient feedback received on the product to date, and believe there will be strong interest from other companies to step in and continue to drive the launch of NATESTO.”

[This report was updated from an earlier version to include news of VIVUS' intent to reacquire U.S. and Canadian rights to STENDRA.]








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