As Ampio Pharmaceuticals (AMPE) uses repositioned products to position itself for major growth, the management team is also being fortified to carry out the short- and long-term missions of the company.
Already boasting a team with decades of experience and expertise, the company announced on Monday the addition of Deborah Knobelman, Ph.D., as chief business officer, a position that will report directly to CEO Don Wingerter, according to Ampio's press release.
With multiple clinical trials coming to an end by the end of 2011, and with the commercialization of the sexual dysfunction drug Zertane seemingly imminent, major near-term growth could be in store for Ampio, and management believes that Knobelman bears the experience and skills necessary to maximize the value of the company's pipeline.
From Monday's release:
Dr. Knobelman spent three years at Pfizer, most recently as Director of Strategy and Analytics for Pfizer's Primary Care product portfolio. From 2000 to 2007, Dr. Knobelman worked on Wall Street as an Equity Research Analyst covering the Specialty Pharmaceuticals sector for several investment banks, including JPMorgan and Piper Jaffray.
The advantage that Dr. Knobelman brings to the table, in my opinion, is that not only does she have experience developing strategies to maximize sales for a major pharmaceutical company, but she also has the experience as a Wall Street analyst. With noted experiences of sitting on both sides of the fence, she would hold the augmented ability to ascertain the true potential value of a product from varying perspectives, undoubtedly a benefit in negotiating a product towards full commercialization.
As Ampio CEO Don Wingerter noted,
Dr. Knobelman's experience and leadership will improve our team's ability to optimize the value arising from these drugs, other clinical trials soon to be initiated, and the many drug compounds in our product portfolio under preclinical development.
Included in that pipeline that Dr. Knobelman will help to optimize are multiple repositioned products that would potentially enter multibillion-dollar markets.
Lead product Ampion, for example, is being developed to target the $80 billion anti-inflammatory and autoimmune disease markets. The advantage that Ampio has with Ampion is that it is a biologic -- a molecule already produced by the human body (as albumin), and already has an established safety profile both because it is a natural part of the body and because it is already commercially available, has already been used in humans and has an established safety profile.
Ampio has targeted osteoarthritis in the knee as the first potential use for Ampion, and the completion of an ongoing trial fir this indication are expected before the end of the third quarter.
Also on the plate is Optina, an oral drug for the treatment of diabetic macular edema and diabetic retinopathy. This product candidate is being repositioned to treat the said indications from the already-approved Danazol. It was found that Danazol, when used in very low doses, actually reverses the effects it demonstrates when used at higher doses and was therefore repositioned by Ampio to treat the horrendous eye conditions that can occur as a result of diabetes.
Again, because Danazol is already commercially available and has been used in humans for some time, the safety profile is established, which means that once results are known from an ongoing trial in Canada -- which should come by the end of the year -- then the regulatory path to approval should be relatively shorter, compared to that of other newly introduced products.
Most immediately on Dr. Knobelman's plate will be Zertane, a repositioned pain medication that has already been on the market for years. The target approvals for Zertane in the treatment of premature ejaculation will all be outside of the USA, since the US FDA does not recognize PE as a qualified medical condition.
With trials for Zertane already having been completed, it's game time for bringing this one to market.
Ampio also has a pipeline of diagnostic technology being developed, which I'll discuss at a later date.
The long term goals of the existing management team have quickly become short-term catalysts, and the addition of the experiences and qualifications of Knobelman to the Ampio team look to be a valuable addition.
Disclosure: I am long AMPE. VFC's Stock House is not compensated to cover Ampio.