GREENWOOD VILLAGE, Colo., April 10, 2014 /PRNewswire/ -- Ampio Pharmaceuticals Inc. (NYSE MKT: AMPE) today announced that its wholly-owned subsidiary Vyrix Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing late-stage prescription pharmaceuticals to improve men's sexual health, has signed an agreement with Paladin Labs Inc., a leading Canadian specialty pharmaceutical 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 Chief Executive Officer of Vyrix Pharmaceuticals.
Disbrow continued, "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. 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. We believe 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 1-2 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.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
About Vyrix Pharmaceuticals
Vyrix Pharmaceuticals was created as a wholly-owned subsidiary of Ampio Pharmaceuticals in order to maximize the clinical and commercial potential of its late-stage sexual dysfunction products. Vyrix is currently focused on advancing the development of Zertane™ for Premature Ejaculation (PE) in the US and around the world.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and emerging markets. Paladin has a focused marketing and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL), a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Learn more at www.endo.com.
Forward Looking Statement Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, including the ability of Vyrix to obtain regulatory approval of Vyrix, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
SOURCE Ampio Pharmaceuticals, Inc.