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Ampio Pharmaceuticals Spins-Off Sexual Dysfunction Business

Stocks in this article: AMPE

GREENWOOD VILLAGE, Colo. , Dec. 13, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has spun off its sexual dysfunction business into a standalone company called Vyrix Pharmaceuticals, Inc. The new Company is expected to be funded through an initial public offering.

(Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)

Vyrix' assets will include Zertane and Zertane-ED, late stage men's health products from Ampio's portfolio. Vyrix' initial business strategy is to initiate and complete registration trials for Zertane in the US and develop worldwide commercialization and marketing partnerships. The Company will work to build awareness of PE in the US with the intention of paving the way for successful product introduction and initiate pre-clinical work on Zertane-ED, a potential combination treatment for premature ejaculation and erectile dysfunction.

"The spin off and subsequent funding, if completed, would give both Ampio and Vyrix greater flexibility to focus on and pursue their respective development strategies while potentially providing shareholders with greater value over the longer term," said Michael Macaluso, Chairman and CEO of Ampio.

The new company introduced today as Vyrix Pharmaceuticals, Inc. will be headed by Chief Executive Officer Jarrett Disbrow. Mr. Disbrow was previously Founder, President and CEO of Arbor Pharmaceuticals, Inc., where he was responsible for all aspects of the business including fundraising, business and product development, licensing, and partnerships. During his tenure at Arbor, he oversaw the successful launch of five products and the Company's acquisition in 2010.

Jarrett Disbrow, CEO of Vyrix, commented: "The spin-off and initial funding will give Vyrix a great opportunity to bring innovative products intended to improve men's health and quality of life to market, in addition to the financial flexibility and human resources necessary to pursue development plans for these assets."

Zertane (tramadol) is an on-demand, orally dissolving tablet under development for the treatment of premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The drug has an excellent safety record established during 30 years of human use for other medical indications. Zertane-ED, a combination of Zertane and a PDE-5 inhibitor, may eventually be used to treat premature ejaculation and erectile dysfunction.

Significant research and development milestones have already been completed including two Phase I, two Phase II, and two European Phase III trials. The FDA has previously issued specific guidance on registration trials and validated the Patient Outcome for Premature Ejaculation (POPE) questionnaire as a co-primary endpoint for the two Phase III trials that need to be conducted. Vyrix also inherits clinical trial supplies needed for the two registration trials, two international licensing agreements, and a 10-year supply agreement effective at the date of launch. A marketing application for Zertane has been submitted to the Australian Therapeutic Goods Authority (TGA) and Vyrix hopes to receive approval in 2014. A Counterparty in one of the international licensing agreements, Daewoong Pharmaceutical Co., Ltd, is also obligated to perform the first human clinical trial of the Zertane-ED combination in accordance with FDA guidelines.

Ampio currently expects that completion of the initial public offering could take up to 12 months, and anticipates that Ampio's resulting ownership in Vyrix will be between 50% and 80%. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Ampio does not intend to provide regular updates on its progress regarding this separation, but will announce in conjunction with Vyrix the filing of a registration statement for the proposed initial public offering as well as the pricing and close of the public offering.

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.

Forward Looking Statements 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 statements regarding Ampio's expectations with respect to the completion, timing and size of the registered direct offering, as well as risks associated with clinical trials, expected results, regulatory approvals, 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 without limitation, under Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.  Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.  

Investor Contact: Rick Giles Director of Investor Relations Ampio Pharmaceuticals, Inc. Direct: (720) 437-6530 Email: rgiles@ampiopharma.com

 

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