Ampio Pharmaceuticals, Inc. today announced it has finalized negotiations with the directors of DMI BioSciences, Inc. (DMI) to acquire DMI BioSciences, Inc. This acquisition will give Ampio access to all rights, royalties and patents associated with DMI’s major assets, drugs for male sexual dysfunction including premature ejaculation (PE) and combination drugs to treat premature ejaculation and erectile dysfunction (ED). These assets are protected by multiple issued U.S. and international patents and additional patent fillings. Ampio will also receive valuable Phase III clinical trial data accumulated for the treatment of premature ejaculation.

DMI’s drug for premature ejaculation is a unique lower dose of an existing approved drug with a well established safety profile. The drug demonstrated robust efficacy, safety and patient tolerability in Phase II clinical trials and was licensed to an international specialty pharmaceutical company which started Phase III clinical trials in Europe with its proprietary oral formulation. DMI regained ownership of the male sexual dysfunction drugs when the licensee withdrew from the latest trials due to its recent industry merger and an internal refocusing of therapeutic areas of interest.

“These late stage drugs will complement our existing pipeline of other repurposed drugs that require less time and expense to start clinical trials,” said Don Wingerter, Ampio’s CEO. “As a result, we can have multiple trials running concurrently without the need for excessive capital or a drain on our personnel resources.”

Ampio recently announced it will begin patient recruitment for its trial of Optina(TM) for diabetic retinopathy and has started the CRO selection process for its clinical trial programs. Ampio will explore licensing opportunities for its sexual dysfunction drugs as soon as the terms of the acquisition agreement are approved by DMI shareholders.