Ampio Updates Intellectual Property and Regulatory Exclusivity Strategy to Support the Commercialization of Ampion™
ENGLEWOOD, Colo., March 23, 2017 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announces the issuance of China Patent No 102210852 B for the production of an active ingredient of Ampion™, which completes the intellectual property protection in China.
Mr. Macaluso, Ampio's CEO, noted that "With the issuance of this patent, the Company's two-prong strategy to obtain comprehensive and overlapping Intellectual Property and Regulatory Exclusivity protection for a commercial launch of Ampion™, expected in 2018, is nearing completion. The FDA acknowledged an unmet medical need in patients with pain due to severe Osteoarthritis of the knee, graded as Kellgren-Lawrence Grade 4 (KL 4), for which there are currently no FDA-approved treatments. In order to provide appropriate market access to the large number of patients afflicted by this debilitating condition, Ampio is exploring the interest of large commercial partners able to make the significant investments needed to assist us in providing this drug to all patients in need worldwide and this strategy protects those investments."
Patent Protection:
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, Malaysia, Mexico, 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. The patent families include protection for methods of treating inflammatory disease and compositions of matter comprising diketopiperazine derivatives, including DA-DKP; methods of treating inflammation and T-cell mediated or inflammatory diseases with compositions of matter comprising DA-DKP; the use of DA-DKP for the treatment of degenerative joint diseases; the use of DA-DKP to mobilize, home, expand and differentiate stem cells in the treatment of subjects; methods for the manufacture of DA-DKP containing compositions; the treatment of degenerative joint diseases in a multi-dose treatment regimen; and the use of DA-DKP in the absence of COX-2 antagonist treatment.
Regulatory Exclusivity:
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.
About Osteoarthritis
Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The World Health Organization has determined that OA will be the fourth leading cause of disability worldwide by the year 2020. In the United States, the Centers for Disease Control (CDC) reports that OA affects 13.9% of U.S. adults aged 25 years and older and describes their estimate of 26.9 million U.S. adults afflicted in 2005 as conservative. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with aging, 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 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™, as well as those associated with clinical trials, expected results, regulatory approvals, the ability of Ampio to enter into partnering arrangements, the Biological License Application (BLA) 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
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500
[email protected]
SOURCE Ampio Pharmaceuticals, Inc.
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