ENGLEWOOD, Colo., June 5, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced two
peer-reviewed articles on the clinical application of
Ampion™ are now available online.
"Peer-reviewed journals are an important part of the scientific
process, which requires intensive scrutiny by other experts in the
field of any manuscript submitted before publication. This external
validation of the science behind Ampion™ is very important as we
move forward to commercialize of this product," stated Ampio CEO,
Michael Macaluso.
- Ampion™ is the 'Low Molecular Weight Fraction of 5% human serum
Albumin' (LMWF-5A) that is in development to treat severe
osteoarthritis of the knee (OAK). There are limited efficacious
treatment options for severe OAK. This June
18, 2018 publication reports the safety and efficacy of
Ampion™ (LMWF-5A) as a treatment option for the signs and symptoms
of patients afflicted by severe OAK. Full details of the
publication can be found here:
https://pssjournal.biomedcentral.com/articles/10.1186/s13037-018-0158-0
- The disease-modifying potential of OAK therapies are of
increasing interest to clinicians and patients, especially
including the possible delay of total knee replacements (TKR). The
effect of Ampion™ (LMWF-5A) on delaying TKR is evaluated in this
May 21, 2018 publication, the full
details of which can be found here:
https://pssjournal.biomedcentral.com/articles/10.1186/s13037-018-0162-4
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.