ENGLEWOOD, Colo., May 29, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced:
- The Company and the FDA have agreed to a July 2018 meeting to continue their discussions on
the BLA submission being prepared for Ampion™ as a treatment of the signs and symptoms of severe (KL4) osteoarthritis-of-the-
knee (OAK).
- Ampio was awarded US patent (9,956,217 B2) titled: "Treatment of Joint conditions" that provides method protection,
until the year 2035, for multiple injections of Ampion™. This is supported by the fully enrolled Open-Label Extension (OLE)
study for the assessment of the clinical safety for long-term treatment with Ampion (up to 5 yearly injections) that will
conclude in 2019 and the completed (published) 3 injections trial (STRUT or AP-007).
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
tchilcott@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.