It is a well-documented story that from when a biotech or biopharmaceutical firm starts out with a concept working in the lab, then slowly and methodically obtains proof of concept, proceeds through animal safety testing, preclinical trials, and ultimately US Food and Drug Administration (FDA) approved human testing all while investing millions of dollars, can take as long as 10 or even 15 years. Many times they hit a wall as commercialization evades them due to one factor or another. The failure stories are frequent, the success ones few and far between. The US FDA process is detailed, grueling, frustrating, and lengthy, but ultimately is thought to be the best in the world for assuring safe and effective drugs for the American population, which has among the highest incidences of heart disease, diabetes, and cancer in the world.
Many possible cures, treatments, and remedies never make it out of the lab, past clinical trials, to even flirt with commercialization due to cost factors. So when intelligent people take a novel approach to introducing solutions that can be brought to market efficiently and perhaps cost effectively, one should sit up straight in their chair and pay attention. This would be potential patients, investors, and stakeholders alike.
This may be the case with Ampio Pharmaceuticals (NASDAQ:AMPE). The company develops innovative proprietary drugs with the potential to be safe and effective for improving patient care. Nothing novel there. However, the company's secret sauce if you will, is its product pipeline that includes new uses for already approved drugs and new molecular entities ("NMEs") for important therapeutic areas. These include diseases of the metabolic system, kidneys, eyes and central nervous system, as well as inflammation and sexual dysfunction. By focusing on new uses for pre-approved drugs, the firm has apparently multiple advantages - quick to market, low development costs, and a better chance of success rates because approved drugs typically already have extensive human safety records.
Active listeners and parties of interest
Health care costs are on the minds of the President, Congress, multiple government agencies, medical organizations, hospitals, doctors, patients -even religious organizations extending their reach. Any and all efforts to reduce health care costs have also heightened interest in new uses ('indications') for approved drugs and unique combination products using established drugs. Safety always leads the way in any discussion, pre-clinical, clinical phase, and FDA discussion. Using approved drugs with already extensive safety records is smart and effective, a novel approach. The market for worldwide pharmaceutical sales is projected at approximately $700 to $800 billion annually. The growth continues, even with a population reminded by proof that better living, eating, and exercise habits will reduce disease and the need for healthcare, medical attention and drugs. But many major diseases are still on the rise and the population is living for longer periods. Shrinking research and development budgets because of high come-to-market costs create even more of a demand for repurposed and safe drugs.
In the Pipeline
Ampio has various products that address a host of indications, including Optina™, an oral drug being developed as a new treatment for diabetic retinopathy and diabetic macular edema (damage to the retina of the eyes, caused by complications of diabetes mellitus that results in loss of vision). Ampio also is developing Vasaloc™, another oral drug, as a new treatment for diabetic nephropathy (a progressive complication of diabetes that leads to end-stage renal disease (ESRD) requiring kidney transplantation or chronic dialysis).
Additionally, Ampio is developing Ampion™, an NME as a non-steroidal injection and oral drug for the treatment of diseases involving inflammation. Concurrently, Ampio is working on a hand-held, point-of-care unit Oxidation Reduction Potential (ORP) medical device used for treating diseases such as heart attack, stroke and respiratory failure. The inventive diagnostic device measures total oxidative stress, which can be considered much like the vital signs routinely measured in medical practice.
The potential impact of a Viagra-like product
The introduction of Viagra by Pfizer Corp. (NYSE:PFE), a drug used to treat erectile dysfunction and pulmonary arterial hypertension (NYSE:PAH), changed the landscape for men and women across the world. Viagra has been a billion dollar drug for Pfizer.
Of similar indication is premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. Ampio's Zertane™ is an oral drug in late stage development that is a proprietary treatment for premature ejaculation.
Known to have an excellent safety record established during 30 years of human use, it's thought that a promising and significant market exists. Initial randomized, controlled clinical trials (phase II) demonstrated that Zertane™ is an effective treatment with few adverse side effects for men with premature ejaculation.
Ampio Pharmaceuticals has a market cap of 113.87M, trading at $3.66, with a 52wk Range of 2.57 - 9.27.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.