ENGLEWOOD, Colo., Oct. 4, 2018 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today provided an update of the ongoing Company activities required to file a Biologics License Application (BLA) for Ampion™ for the treatment of severe Osteoarthritis of the knee (OAK).
Michael Macaluso, Ampio's CEO, noted that "During the time that AP-003-C, the second of our two required pivotal phase III clinical trials, was designed and executed, the FDA underwent a major reorganization. As a consequence, Ampio was overseen by three different review groups representing two different review offices within the Center for Biologics Evaluation Research (CBER). Currently, Ampion is being reviewed by CBER's newly formed Office of Tissue and Advanced Therapies (OTAT)."
The company is currently focused on completing the following regulatory requirements established by the FDA:
Perform two pivotal clinical trials of Ampion that CBER accepts as adequate and well-controlled studies that demonstrate the safety and efficacy of Ampion. These two pivotal trials are not required to be identical but must meet pre-determined endpoints and provide substantial replication of results.
All Ampion clinical studies must provide evidence in support of a BLA.
FDA must accept the Chemical and Manufacturing Controls (CMC) program for the investigational product.
Ampio Corporate Update: The Company is reporting the following milestones in support of the three objectives outlined above:
On August 16, 2018, OTAT reaffirmed that "FDA considers AP-003-A to be an adequate and well-controlled clinical trial that provides evidence of the effectiveness of Ampion. AP-003-A can contribute to the substantial evidence of effectiveness necessary for the approval of a BLA." Over 2,000 patients now support the substantial evidence necessary for the BLA.
The AP-003-C OLE study was designed to support the safety and tolerability of repeat injections of Ampion (up to five injections) over the course of at least one year. No serious drug-related adverse events have been reported, and all patients demonstrated a sustained reduction in pain over the course of the trial.
On September 27, 2018, OTAT provided a favorable response, with no areas of dispute, in support of CMC for the Ampion BLA. Agreement was obtained "on the CMC data requirements for BLA and on the data presented for analytical characterization, commercial release specifications, and potency of Ampion drug product."
The Company is continuing discussions with the FDA to determine if the pivotal AP-003-C study is the final trial required to support the Ampion BLA. Should another trial be required, the Company will move quickly to meet the FDA requirements under a Special Protocol Assessment (SPA).
Regulatory Exclusivity and IP protection: The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a "reference product" upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.
About Osteoarthritis Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes, this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a development 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 the 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 Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. 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 other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact Tom Chilcott Chief Financial Officer Phone: (720) 437-6500 [email protected]