ENGLEWOOD, Colo.,
Jan. 8, 2018
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT:
AMPE) announces that the company will be updating potential
collaborators and attending shareholders at the J.P.
Morgan Healthcare Conference, the largest and most informative
healthcare investment symposium in the industry.
Michael Macaluso, Ampio's
CEO, noted "Now that Ampio has successfully completed the second of
the two Phase III clinical trials required for a Biologics License
Application (BLA) to the FDA, the Company will be updating the
healthcare investment community on our progress. In order to
assure that all our investors receive the same information, we have
today posted these slides on our website
(http://ampiopharma.com/investors/presentations-media/)
in a read-only format and have filed an 8-K with the
SEC.
Shareholders who wish to gather more information about the
clinical path of Ampion™ for the treatment of
Osteoarthritis-of-the-knee (OAK) may want to review these press
releases:
- August 14, 2013, Ampio
Pharmaceuticals, Inc. Announces Positive Results for Ampion™ in
Osteoarthritis of the Knee Clinical Trial
http://ampiopharma.com/news/ampio-pharmaceuticals-inc-announces-positive-results-ampion-osteoarthritis-knee-clinical-trial-2/
- December 2, 2013, Ampio
Receives FDA Confirmation that the Spring Study is Pivotal and Will
Initiate the Final Pivotal Trial for Ampion™ Biological Licenses
Application(BLA)
http://ampiopharma.com/news/ampio-receives-fda-confirmation-spring-study-pivotal-will-initiate-final-pivotal-trial-ampion-biological-license-application-bla-2/
- July 30, 2014, Ampio
Pharmaceuticals announces the FDA has issued a written response
accepting the Ampio plan for beginning production of Ampion™ in the
new facility
http://ampiopharma.com/news/ampio-pharmaceuticals-announces-fda-issued-written-response-accepted-ampio-plan-beginning-production-ampion-new-facility-2/
- December 14, 2017, Ampio
Pharmaceuticals Reports Positive Results for both Primary and
Secondary Endpoints of Pivotal Phase 3 Trial of Ampion™ in Severe
Osteoarthritis-of-the Knee(OAK)
http://ampiopharma.com/news/ampio-pharmaceuticals-reports-positive-results-primary-secondary-endpoints-pivotal-phase-3-trial-ampion-severe-osteoarthritis-knee-oak/
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" if its BLA is approved
by the FDA. 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 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 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™, 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 includingregulatory
risk. 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.