Contributor Since 2013
In last weeks press release from Ampio Pharmaceuticals (AMPE) Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the FDA letter summarizing the FDA's conclusions of the Ampion Phase III Trial stated, "The strength of the evidence is robust." "Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two "pivotal trials" required in support of a BLA." "This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks)." The final trial for the potential blockbuster Ampion looks very promising and is scheduled to begin next month with results known by May.
Ampion is a novel anti-inflammatory that has shown remarkable results for both efficacy and safety in its last two trials. To repeat, the FDA even called Ampion results "robust." Ampion is expected to be used for a larger number of indications with the first undergoing final pivotal trials for osteoarthritis of the knee and thereafter for the 27 million osteoarthritis sufferers of remaining joint illnesses. The company also announced plans for upcoming Ampion trials to treat Chronic Obstructive Pulmonary Disorder, COPD, and Crohn's Disease. If Ampion is approved, and it is looking brighter every day, Ampion could easily become a new blockbuster drug for Osteoarthritis and several other maladies. Ampion is a far more attractive option to knee and joint replacements.
All by itself, the drug Ampion would be more than enough to create very excited and happy investors, but this company has a pipeline beyond Ampion that would make any Fortune 500 company envious. Ampio Pharma is also developing 2 other blockbuster drugs that are equally likely to succeed with an FDA approval and equally close in time for approvals. Optina used to treat Diabetic Macular Edema, "DME", is in a Pivotal Phase 505 B 2 Trial with completion expected in Q1 2014 and Top Line results soon after. October 7th, an Independent Data Review Committee announced positive interim results and recommended continuation of the trial.
Optina may have a large advantage over the competition because it is a pill and not an injection. If approved, Optina will probably gain the support of insurance companies and government because it will be far less expensive than competing drugs like Lucentis and Eylea. An article that appeared in the scientific journal, Retina Today featured a cover story on Optina last year called, Oral Danazol For DME. The article explains how Optina works to actually repair the leaking blood vessels in the eye and not just mask symptoms. The progress of Optina is being watched very closely by Regeneron (REGN) shareholders because an approval of Optina could be devastating to the injection Eylea and results from the prior trail were so successful, the trial was concluded ahead of schedule.
Zertane is used to treat the male sexual dysfunction of Premature Ejaculation and while the company has been very quiet about Zertane, it is about to receive approvals in 19 countries and management is in discussions with several large pharma companies about a possible licensing deal or partnership. It is estimated that close to 25% of the male population suffers from PE. The company is also developing Zertane ED that is used to treat both PE and ED simultaneously in one pill. The biggest challenge developing Zertane was creating a Patient Outcome PE Questionnaire that was acceptable to the FDA for the Phase III trial. Early this year, the FDA approved Ampio's POPE and cleared the way for the final trial that is estimated to be around 12 weeks in duration. At this month's Piper presentation, Mike Macaluso, Ampio CEO, said to expect an announcement by the company by the end of this year about Zertane.
Oxidation Reduction Potential, "ORP" is a revolutionary diagnostic that has the potential to save millions of lives and billions of dollars. A patient's ORP is measured using the company's proprietary RedoxSYS™ diagnostic system, a point-of-care diagnostic system enabling rapid analysis of multiple markers of oxidative stress. Recent studies produced positive results for hip fractures and traumatic brain injury Ampio owns worldwide patents and is pursuing worldwide commercialization with approvals expected in 2014.
Like all emerging pharma stocks, Ampio Pharmaceuticals has been controversial and volatile, offering traders the short-term price swings they require for profit opportunity and investors the long-term uptrend that is solidly in place. Ampio has been the object of healthy skepticism in several articles for the last two years, but now appears poised to begin delivering successful pivotal trials, licensing deals and FDA approvals by early 2015.
Young and fast-rising companies like Ampio are typically technology rich and cash poor but Ampio finds itself with plenty of cash and even recently raised an additional $25 million to insure adequate financing for its active clinical trial activity.
Risk is always present will all companies, especially publicly traded companies where the markets are susceptible to elements beyond a company's control and Ampio is no exception, but with all the overwhelming news to come, Ampio appears more likely than not to be headed for a Melt-Up that could surprise big.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.