Ampio Reaches Agreement with the TGA for the Submission Plan for Zertane in Australia
04/02/2012 | Press Release
GREENWOOD VILLAGE, Colo., April 2, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE - News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), announced today that it reached agreement with the Therapeutic Goods Administration (TGA), Canberra, Australia, on a plan of drug manufacture and quality control for Zertane™ and the overall plan for the preparation of Common Technical Documents for the draft registration submission expected to be filed in June 2012.
Michael Macaluso, Ampio's CEO noted, "Zertane™, the company's repurposed medication, low dose Tramadol, designed for the treatment of Premature Ejaculation (PE) successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open label study of 101 patients demonstrated no abuse potential or dependency."
Mr. Macaluso further noted, "The only alternative medication for PE, Johnson and Johnson's Priligy™ is already approved in Australia. Registration of Zertane™ in Australia will not only open up the Australian market but assist the regulatory process in other countries, such as Korea and Brazil where the company has existing licensing agreements."
Vaughan Clift, MD, Ampio's Chief Regulatory Officer, added, "In parallel to preparing the submission document, the company will begin production of the initial product runs and quality testing, which are necessary for the full submission document to be filed and the company does not believe, at this stage, that any further clinical or preclinical trials will need to be conducted to support the submission."
Zertane™ is a repurposed oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient in Zertane™ has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane™ from other treatments for premature ejaculation. Zertane™ is taken as needed before sexual activity, and is not required on a daily basis.
Published in the September 2011 journal of European Urology: "A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Less than 2 Minutes" authored by Dr. David Bar-Or, MD, the Chief Scientific officer and his colleagues at Ampio Pharmaceuticals Inc, details the successful efficacy and safety outcomes of the use of Zertane™ in double blinded, placebo controlled phase III trials involving 604 intent to treat patients in 11 countries and 62 sites in Europe. Premature ejaculation is a widely observed male sexual dysfunction with an estimated prevalence between 2% and 23% of the world male population. Studies have shown that PE is associated with poor satisfaction with sexual intercourse and high levels of ejaculation-related personal distress and interpersonal difficulty. The study conclude that on demand Zertane™ provides a new option for managing mild to severe PE and that very favorable efficacy and safety profiles exist. The median IELT (intravaginal ejaculatory latency time) of Zertane™ increased by 1.2 minutes (2.4 fold increase) compared to placebo (p<0.001). All four measures of the PEP (Premature Ejaculation Profile, a validated questionnaire) scores improved significantly compared to placebo (p<0.05) in men and a large percentage of women partners who had poor or very poor satisfaction with sexual intercourse, partner's control over ejaculation and speed of ejaculation improved significantly with Zertane™ in at least one category or greater with satisfaction with sexual intercourse (p=0.01), their partner control over ejaculation (p<0.001) and distress over partner's speed of ejaculation (p=0.02).
About the TGA
The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products including goods used to treat serious conditions, for example prescription medicines, vaccines, blood products and implants. The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market and assesses the suitability of medicines and medical devices for export from Australia. The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
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, successful commercialization and marketing of Zertane™ and the combination drug in Korea, 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.
Contact: Investor Relations Ampio Pharmaceuticals, Inc. 720-437-6500
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