After announcing that Ampio Pharmaceuticals has licensed Zertane™ marketing rights to Daewoong Pharmaceuticals in South Korea as a treatment for premature ejaculation (PE), Don Wingerter, Ampio's CEO, says that since publishing the summary of positive clinical results of the treatment's two European Phase III trials on June 17, his firm has seen more interest in the drug.
"We have been contacted by numerous companies from all regions of the world seeking to license Zertane™," said Wingerter. "As regulatory pathways and cultural attitudes vary from country to country, we have decided that optimizing Zertane™ sales around the world is best accomplished with country and region specific partners, each carefully chosen, and not with a single global partner. Each partner must have a strong presence and be committed to, and capable of, mounting a comprehensive campaign to launch and grow the sales of the product. In South Korea, it was clear that Daewoong was the ideal partner for Ampio."
Mr. Wingerter continued :"As Zertane™ is patent protected in 32 countries, Ampio is pursuing similar agreements with additional regional partners, some of whom already have market approval for the active ingredient of Zertane™ in various formulations, thereby accelerating time to market.
The newly announced licensing deal covers a combination drug, using Zertane™ and another erectile dysfunction drug (PDE5 inhibitors and others), to simultaneously treat premature ejaculation and erectile dysfunction (ED). The agreement allows Ampio to get multi million dollar upfront, regulatory and sales related milestone payments to Daewoong, and a royalty stream equal to 25% of net sales less Ampio's transfer price. Additionalyy, Daewoong will also fund a full Phase III clinical trial for Ampio's follow on combination PE/ED drug.
Earlier this week, we first told our readers about Ampio when shares were trading near the $7.50 mark. In his article, Brian Wilson told readers that Ampio will be releasing new information regarding all 7 of its products undergoing clinical trials near the end of the third quarter of 2011, including anticipated business outlook and licensing agreements for Zertane in the EU and Asia. He pointed out that these forward looking developments could very well spark investor interest. Shares closed Thursday's trading session at up at $8.24.
As we pointed out, Ampio Pharmaceuticals is potentially in a strong position with their pipeline, targeting huge drug markets while maintaining minimal costs. There are a small number of shares available, and the potential for explosive growth in the company’s valuation is existent. We anticipate a large outflow of news and information at the end of Q3 2011, which should draw even more investors to the company.
Ampio Pharmaceuticals, Inc. discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"). Zertane™ is an oral drug in successful 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. 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. 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 to be taken on a daily basis.
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