Company announces a manufacturing agreement with Enthypharm Ltd for Ampio’s Male Sexual Dysfunction drug.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical-stage biopharmaceutical company developing drugs for sexual dysfunction, inflammatory diseases and ophthalmological conditions has announced a manufacturing agreement with drug delivery maker Enthypharm Ltd for Zertane, Ampio’s drug for the treatment of premature ejaculation (PE).
Zertane has completed Phase III trials in Europe, and the company has received guidelines for two pivotal trials after a successful pre-IND meeting with US FDA.
The manufacturing agreement will be used to:
- Complete the IND for the conduct of pivotal trials in the US
- Complete the registration package for approval of Zertane by the TGA in Australia, used for approval in South Korea and Brazil
- Finalize pricing of Zertane for launch internationally and clarification for licensing negotiations with additional potential partners
Ampio develops re-purposed drugs and new molecular entities, with diverse clinical applications, including osteoarthritis, diabetic macular edema (DME), kidney disease, cancer and sexual dysfunction.
Ampio is in clinical phase with four lead drugs: Zertane™ (Phase III, sexual dysfunction); Optina (entering Phase III, ophthalmology); Ampion (entering Phase III, chronic inflammation); and Vasaloc (entering Phase II, nephrology).
This update caps a busy summer for the Colorado-based biotech. The company conducted a pre-IND meeting with the FDA’s ophthalmology division of the Center for Drug Evaluation and Research on July 31st to map out the clinical trial path of Optina, the company’s orally administered low dose of danazol for the treatment of DME.
Earlier in July, the company announced the closing of an underwritten public offering worth $17.8MM, in which it received gross proceeds of $16.9MM. The offering consisted of 5.4MM shares of common stock, including 692k shares of common stock sold by Ampio at an over-allotment option at a price of $3.25 per share. Aegis Capital Corp. and Fordham Financial Management, Inc. acted as joint book-running managers for the offering.
Two days earlier, Ampio announced the advancement of NCE001, from the company’s proprietary methylphenidate derivatives family of compounds, to preclinical development for the treatment of glioblastoma multiforme, renal cell carcinoma and inflammatory breast cancer. The announcement followed the granting of multiple composition of matter and use patents in the US, Canada, Europe and China.
Shares spiked to a peak of $5.43 upon a July 2 announcement that the company would proceed with a development plan for Zertane after a positive pre-IND meeting in June with the FDA. The FDA gave clear guidance for the two concurrent pivotal trials necessary for the approval of Zertane in the US, and identified PE as a disease condition and subsequent treatable ailment.
Shares came back down to earth the following week, hovering at $3.00 and reaching a nadir of 2.65 in mid-August. Ampio shares have rebounded with the most recent announcement, climbing 40 percent from $2.65 in mid-August to around $4.00 in late September.
The manufacturing contract of Zertane follows successful Phase III studies in Europe and successful pre-IND meetings with the FDA. According to the company, the active ingredient in Zertane has an excellent safety record established during 30 years of human use for other medical indications. The company is manufacturing Zertane in ODT-Orally Dissolving Tablets to be taken as needed, not requiring a daily dose.
No drug has yet been approved in the U.S. for the treatment of premature ejaculation, the most common male sexual dysfunction. It is estimated that between 2% and 5% of men experience lifelong PE, while typically 20% of men complain of PE disorders. Selective serotonin reuptake inhibitor antidepressant drugs and a numbing anesthetic drug spray have been approved in some other countries, although both of these treatments are reported to have significant side effects.
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