ENGLEWOOD, Colo., July 30, 2014 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company’s plans to begin production of AmpionTM in our new drug manufacturing facility.
Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer explained, “Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application can be one of the most complex elements of the Biologics License approval process and generally requires face-to-face meetings and teleconferences with the FDA to resolve issues. However, based on a review of our submitted proposal to satisfy the CMC requirements, the FDA suggested that the planned face-to-face meeting was no longer necessary, and all minor remaining issues can be resolved by written exchange prior to the BLA filing”.
Mr, Macaluso, Ampio’s CEO, noted that,”This decision by the FDA was greatly encouraging to our management team as it supports the quality of our efforts to develop and implement a comprehensive plan to manufacture AmpionTM in our new facility, fully compliant with all FDA regulations. This plan requires no additional clinical trials to bring our manufacturing facility online. Our Colorado facility will be a show piece as well as a significant asset to the company.”
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a clinical trial stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statements
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to the completion, timing and size of the registered direct offering, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6500