Ampio to seek foreign OKs for premature ejaculation drug

Ampio Pharmaceuticals ($AMPE) is gearing up to seek international regulatory approval for its drug to treat premature ejaculation. The company disclosed Dec. 5 that it is preparing for this, in part, by securing rights to additional drug delivery technology for quick-dissolving oral tablets.

The Greenwood Village, CO, company disclosed Dec. 5 that it inked a deal with an unnamed party to acquire "certain rights" related to the patented tech "over and above" the patents Ampio already owns for Zertane.

Financial details were not discussed, but Ampio said the agreement will help protect its proprietary orally disintegrating tablet formulation for Zertane, which completed Phase III clinical trials in Europe. Ampio disclosed in a recent regulatory filing that it is being courted by various marketing partners for the drug and is beginning the regulatory approval process for Zertane "in select countries" outside the U.S. and in Europe.

Such a quick-action pill should elevate the global market, the company said, in part because of its ease of use. An orally disintegrating tablet can be absorbed more quickly without needing to wash it down with liquid. It will also act faster and it won't taste bitter.

Zertane is designed with a PDE5 inhibitor so it can treat both premature ejaculation and erectile dysfunction. No pill in the U.S. has been approved yet to treat premature ejaculation, the company notes.

At least in the erectile dysfunction space, the company faces sizable competition. Globally, that market has surpassed $5 billion, The New York Times reported in April. Companies such as Pfizer ($PFE) and Bayer have turned to dissolvable oral tablet versions of Viagra and Levitra, respectively, to offer unique alternatives in anticipation of their initial blockbuster drugs eventually turning generic.

- here's the release
- read the related NYT piece

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