ENGLEWOOD, Colo., May 14, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE), a developer of novel
therapeutics to address significant inflammatory conditions for
which limited treatment options exist, today announced updates to
shareholders that address questions recently posed to management by
shareholders:
- During Q1, the Company received a total of $3.1 million from investor warrants and stock
options being exercised.
- Discussions with the FDA are ongoing to address FDA
questions and provide the company's responses, as the Agency
encourages companies to discuss all facets of regulatory filing,
including clinical results, labeling, Chemistry, Manufacturing and
Controls (CMC), and other aspects of the development process prior
to filing their BLA in order to reduce the possibility of receiving
a Refusal to File (RTF) notification.
- The Company has hired additional internal staff dedicated
solely to supporting the efforts of our BLA consultant, Parexel® in
the preparation of the CMC filing.
- We continue discussions with outside partners that address the
commercial potential of Ampion™ in multiple world markets.
- The Company issued the 3/31/18
10-Q on 5/10/18.
- The Company is actively pursuing endeavors to strengthen the
balance sheet.
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 12 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.