GREENWOOD VILLAGE, Colo., Sept. 28, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it has received notification of allowance of its two patent applications on Zertane™ combinations with erectile dysfunction (ED) drugs in Canada. This allowance includes claims directed to the use of Zertane™ with a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors commonly used for the treatment of ED to address concurrent premature ejaculation (PE) and ED. The allowed claims also include composition of matter claims, such as claims directed to a pharmaceutical composition or a kit containing Zertane™ and a PDE5 inhibitor. Similar patent applications are being prosecuted worldwide.
It has been reported that ED and PE can co-exist in up to 30% of patients. There may be patients with ED who are effectively treated with phosphodiesterase type 5 inhibitors but who may have PE. The patented combination of PE and ED drugs addresses this substantial group of patients.
"This first allowance of these two patents in Canada is an important milestone in Ampio's strategy to continue the development of its sexual dysfunction portfolio by first obtaining strong intellectual property protection," said Don Wingerter Ampio's CEO. "We are very excited by this development as we anticipate it will help increase our growing out-licensing activity for this product line," continued Don Wingerter.
The active ingredient in Zertane™ is a drug that was approved for marketing as a noncontrolled analgesic in 1995. In two Phase III clinical trials, Zertane™ has proven to be an effective oral medication to treat PE in men. Premature ejaculation is the most common form of male sexual dysfunction (four times the number with ED) with an estimated 23% of males suffering from this condition. The impact on the quality of life for these men and their partners can be profound. Behavioral therapy is the current standard of care for treatment of PE.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS 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, future intellectual property rights, successful commercialization and marketing of Zertane™ and combination drugs, successful licensing and partnering activity, 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
SOURCE Ampio Pharmaceuticals, Inc.