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.