LifeSci Advisors Initiates Coverage of Ampio Pharmaceuticals
Optina Is Currently in a Pivotal Phase IIb Trial -- First Oral Drug for Diabetic Macular Edema; Phase II Run-In Trial for Ampion to Treat Osteoarthritis of the Knee to Begin in 2013; Available for Download at www.lifesciadvisors.com/clients/ampio/
NEW YORK, NY -- (Marketwire) -- 03/07/13 -- LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE), a biopharmaceutical company focused on the rapid development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's leading development candidates are Ampion for osteoarthritis of the knee and Optina, which has the potential to be the first oral therapy for diabetic macular edema.
"Ampio's focus on developing therapies for inflammatory conditions with limited treatment options and large market opportunities has the potential to yield multiple marketed products," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "For example, Ampion for osteoarthritis of the knee address a market worth more than $1.3 billion in the US annually, and the global macular edema market addressed by Optina is rapidly approaching $2 billion per year."
Ampion is a patented, naturally occurring compound in the human body that is derived from serum albumin, which has been safely used as a therapeutic for decades. Ampio is initially developing this drug candidate as an intra-articular injection to treat osteoarthritis of the knee. Ampio announced that the FDA requested one Phase II dose-escalation study as a run-in to the pivotal Phase III study. To this end, the Company intends to conduct a Phase II dose-finding study in patients with osteoarthritis of the knee that will be followed shortly thereafter by a single, pivotal Phase III trial, which could read out in 18 months. However, the compound may also have activity in other inflammatory conditions. For example, Ampion has the potential to be aerosolized as a treatment for allergic rhinitis, or a synthetic form may eventually be used as a treatment for autoimmune disorders.
Optina (danazol) is an ultra-low dose version of an existing drug that is being developed for diabetic macular edema. Ampio discovered that an ultra-low dose acts differently than currently-used therapeutic doses, allowing for strong patent protection. The fact that the drug has an established clinical track record minimizes safety risk and creates the possibility that Optina could be approved on data from a single trial. On February 27, 2013, Ampio announced that the first patient has been dosed in the Optina pivotal trial. The Company has not announced a timeline for completing the trial; however, an interim analysis is planned after 4 weeks.
In a 47-page Initiation Report by LifeSci Advisors, we explain Ampio's overall development strategy, including a device platform that has been carved-out into a separate company and a pre-clinical candidate that possesses a novel mechanism of action for cancer treatment in addition to Ampion and Optina. The report provides a deep look into the scientific rationale behind each of Ampio's development programs, competing products and development programs, and examines the patient population and market opportunity for each drug candidate.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
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