Ampio Pharmaceuticals (AMPE) released positive trial news for Optina in the treatment of Diabetic Macular Edema (DME) earlier this week and shares quickly spiked to over the four dollar mark as a result. Although shares have since retreated to under that price, the results solidify a trend that has the company's pipeline of repositioned products on a roll.
Before the positive Optina results, Ampio also informed investors and the medical community that its potential blockbuster product, Ampion, had been successful in multiple trials as an anti-inflammatory. Given the side effects that are carried with today's standard anti-inflammatory treatments, Ampion could come along just at the right time when medical professionals are looking for alternatives.
On Thursday the company provided an update on its third lead product, Zertane, for the treatment of premature ejaculation (PE).
Similar to a deal announced last year when Ampio licensed Zertane to Daewoong Pharmaceuticals Co. Ltd. of South Korea, the company has now licensed the product to FBM Industria Farmaceutica Ltda ("FBMFarma") for commercialization in Brazil.
Financial terms of the deal were not disclosed, but FBMFarma will be responsible for achieving regulatory approval, marketing and distribution.
Zertane has already cleared late stage trial hurdles and the results of those trials have been widely published and disseminated. The company's strategy for commercialization is to partner with well-established, regional entities that are familiar their own region's regulatory processes and distribution networks. The focused deals in Brazil and South Korea are testaments that the company can be successful implementing that strategy.
Ampio does not have ambitions of commercializing the product in the United States, as the FDA has not labeled ED as a medical indication, although wives and girlfriends around the country would most likely disagree with that assertion.
Brazil is also no place for this medical condition, so predictably, both Ampio and FBMFarma have high hopes for the success of the product on the Brazilian market.
"FBM group executives are very pleased to establish this partnership with Ampio, since they are extremely confident and enthusiastic about the success that Zertan will have in the Brazilian market," noted Alexandre Ferreira, FBM group's Director of Marketing in Thursdays press release.
With another Zertane deal in place, Ampio has now announced positive progress on all three of its main pipeline fronts within the past few months. The company's strategy of finding new indications to treat with already-approved drugs looks to be paying off at a rapid pace.
There are still quite a few trial developments pending for later this year, most notably the initiation of pivotal trials that will be required to get through the FDA, and any additional Zertane deals could just be icing on the cake for Ampio.
Disclosure: Long AMPE.
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