Ampio Pharmaceuticals’ wholly-owned subsidiary Vyrix Pharmaceuticals, a specialty pharma company focused on developing and commercializing late-stage prescription pharmaceuticals to improve men's sexual health, has signed an agreement with Paladin Labs, a Canadian specialty pharma company, to provide exclusive rights to market, sell and distribute Zertane in Canada, the Republic of South Africa, Sub-Saharan Africa and Latin America.

"We are pleased to have Paladin as our first North American partner to commercialize Zertane. Our agreement with Paladin is consistent with Vyrix's global commercialization strategy focused on developing partnerships with established companies that are dominant in key international markets and have a specialty that aligns with Zertane to maximize its visibility," said Jarrett Disbrow, president and CEO of Vyrix Pharmaceuticals.

"This agreement further broadens the international footprint for Zertane by adding Canada, Africa and Latin America to our existing partnerships in South Korea and Brazil where the pending Australian TGA approval of Zertane should enable product registration in the near-term,” he said. “We continue ongoing discussions with additional potential partners, which we believe will position Zertane to gain maximum international exposure and drive more value than aligning with a single worldwide partner."

Zertane (tramadol HCl) is an oral drug in late-stage development as a proprietary treatment for premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners and has demonstrated a favorable efficacy profile in clinical trials. The company believes the active ingredient in Zertane has multiple mechanisms of actions that can delay ejaculation. These pharmaceutical qualities, favorable safety profile and a distinctive non-standard dosage not available in generic form, differentiate Zertane from other treatments for premature ejaculation. Zertane is to be taken one to two hours before sexual activity as needed and is not required to be taken on a daily basis. There has not yet been an oral drug approved in the U.S. for the treatment of premature ejaculation.

The agreement provides for an upfront payment, approval and revenue-based milestone payments and an ongoing double-digit royalty stream to Vyrix. Paladin and Vyrix will collaborate to apply for Health Canada approval for Zertane to enable near-term registration in Canada with registrations in other countries in the Territory to follow.