Ampio Announces the Allowance of a Composition and Methods Patent in the USA Using Ampion™ in Conjunction with Stem Cells

ENGLEWOOD, Colo., August 8, 2017/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) is pleased to announce today the allowance of an important composition and methods patent in the USA complimenting a series of patents on Ampion™ (127 issued and 80 pending). The patent is entitled: “COMPOSITIONS FOR THE MOBILIZATION, HOMING, EXPANSION, AND DIFFERENTIATION OF STEM CELLS AND METHODS OF USING THE SAME.” The patent includes 34 allowed claims.

Autologous or allogenic stem cells are used in clinical practice, including for osteoarthritis of the knee. Ampion™ has demonstrated in vitro effects on mesenchymal stem cells on recruitment and differentiation. This process occurs naturally in the body, however, to augment the number of stem cells that would survive after injection in the body and their differentiation into tissue specific cells (chondrocytes making collagen/cartilage in the case of osteoarthritis), incubating them with Ampion™ prior to injection is the subject of this patent.

Mr. Macaluso, Ampio’s Chief Executive Officer, stated: “This patent expands the potential indications of Ampion™ to conditions where stem cells are administered to patients, mimicking natural in-vivo processes in which a patient’s stem cells are recruited to the site of inflammation. Also, because stem cell therapy is becoming a valid therapeutic option, Ampion™ could be used in conjunction with stem cells to maximize and synergize the desired safe and beneficial effect in osteoarthritis including pain relief.”

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, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 127 issued patents and 80 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 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 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 the 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
Tom Chilcott
Interim Chief Financial Officer
Phone: (720) 437-6500