Heavy volume carried shares of Ampio Pharmaceuticals (AMPE) to well over the four-dollar mark during early trading on Monday after the company announced that interim results from a trial testing Optina as a treatment for Diabetic Macular Edema (DME) were strong enough to justify halting the trial early and moving forward with the FDA's regulatory process.
The early trial halt, according to Dr. Vaughan Clift, Chief Regulatory Officer of Ampio in statements released Monday morning, allows the company to prepare a "consultation package" for the FDA, the next step in setting up for a pivotal trial that would ultimately bring the product before the FDA for approval.
The regulatory path to approval for Optina may come rather quickly, in comparison to other new drugs and treatments making their way through the FDA process for approval, since it is a repositioned indication of Danazol, which already has an established, decades-long safety profile. That track record can be used, in part, to support an approval request for the new indication, which significantly reduces the time and cost involved, were Ampio to bring an entirely new drug to market.
In fact, Ampio has built a pipeline based on that strategy.
Aside from Optina, the company is positioning Ampion to become a major player in the anit-inflammatory market. The product candidate has already proven successful in multiple trials and given the side effects of other anti-inflammatories currently on the market, Ampion could stand to gain market share rather quickly, should it make it past the regulatory hurdles.
Ampio has has targeted the second half of 2012 for an expected start of a pivotal trial that would then be used to support an FDA approval request.
Another repositioned product, Zertane is currently being marketed outside the United States as a treatment for premature ejaculation (PE). A commercialization deal was announced last year with Daewoong Pharmaceuticals Co. Ltd. of South Korea that grants Daewoong the rights to market the product as a treatment for PE. As another condition of the agreement, Daewoong also holds the rights to develop and market a combination drug that combines Zertane with another erectile dysfunction drug to simultaneously treat premature ejaculation and erectile dysfunction (ED).
Ampio is looking to license Zertane in other regional markets, similar to the South Korea deal.
Company shares touched the north side of nine dollars last year as word of Ampio's trial successes circulated the small pharma and biotech circuits, before a late-2011 pullback resulted in a slow open to 2012.
With multiple catalysts now set to evolve over the coming months, this year could prove to be a rebound year - if not pivotal in the company's history, since two of its product candidates, Ampion and Optina, are in the preparatory stages of pivotal trials that - if successful - will lead to an approval request.
Monday's swift price spike and volume that touched over a million shares before the clock even touched noon is a good indication that investors are again starting to take notice.
Disclosure: Long AMPE.