ENGLEWOOD, Colo., Aug. 22, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) a development stage
biopharmaceutical company, executing a special protocol
assessment (SPA) phase three clinical trial titled, "A
Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy
and Safety of an Intra-Articular Injection of Ampion™ in Adults
with Pain Due to Severe Osteoarthritis of the Knee," today
announced that the Company has retained Torreya Partners
LLC as a financial advisor and has appointed Willam Bindley and Bruce E. Terker to a newly formed
Transaction Advisory Committee (TAC).
According to Michael Macaluso,
Ampio's CEO, "We are at a pivotal moment in the Company's
transition from a development stage company to the filing of a
Biologics License Application (BLA) and subsequent
commercialization of our lead drug, Ampion. As such, we are now
upgrading the expertise level primarily devoted to further
evaluating our near term strategic options in a rapidly evolving
healthcare market place. The Torreya Partners team members have a
vast level of merger, investment, and acquisition related
experience which will provide the Company a comprehensive
evaluation of potential partners. In addition, both Mr. Terker
and Mr. Bindley are firm believers in the Company's technology, are
large shareholders of Ampio, and have accomplished successful
transactions in the biopharmaceutical marketplace. Notably, both
individuals will serve without compensation, and have signed
Non-Disclosure Agreements (NDA), thus precisely aligning their
interests with the other shareholders. With Torreya Partners and
TAC members, Mr. Bindley and Mr. Terker, analyzing our
opportunities and advising on our future strategic decisions, we
believe the shareholders interest will be well served."
About Torreya Partners
Torreya is a global investment
banking boutique serving companies in the life sciences industry.
Since its inception in 2007, Torreya has advised clients on more
than $100 billion worth of deals for
biotechnology, branded pharmaceutical, generic pharmaceutical, and
life sciences companies. Torreya's partners are senior
industry bankers and executives, with deep experience, knowledge,
and networks. They are a partner of choice for companies seeking
discreet, conflict-free, and knowledgeable advice on M&A,
pharmaceutical asset sale, capital markets, and licensing
transactions. Torreya has offices in London, Mumbai, New
York, and affiliate offices on six continents. Further
information about Torreya Group can be found at:
https://torreya.com/firm/about-us.php
About Transaction Advisory Committee members
William Bindley
Mr.
Bindley is Chairman of Bindley Capital Partners, LLC, a private
investment firm headquartered in Indianapolis, Indiana and is also a Founder
and Current Chairman of Guardian Pharmacy Services, the largest
privately held long term care pharmacy in the United States. Mr. Bindley also founded
and was Chairman of Priority Healthcare Corporation, a national
provider of bio-pharmaceuticals and complex therapies for chronic
disease states with annual revenues of over $2 billion when it was sold to Express Scripts in
2005 for $1.3 billion. Mr. Bindley
was the Chairman, President, Chief Executive Officer and founder of
Bindley Western Industries, Inc., a national pharmaceutical
distributor and nuclear pharmacy operator that was an NYSE Fortune
200 company at the time of its merger into Cardinal Health Inc., in
2001 for $2.3 billion. He previously
served on the boards of Cardinal Health, Inc., Key Bank, NA,
Bindley Western Industries, Priority Healthcare Corporation, and
Shoe Carnival, Inc. He received both a B.S. degree in Industrial
Economics and a Doctor of Management (H.C.) degree from
Purdue University. He also completed
the Wholesale Management Program at the Graduate School of Business
at Stanford University. He is the past
Vice-Chairman of the United States Ski and Snowboard Association
and serves on the President's Advisory Council at Purdue
University. Mr. Bindley provided funding for the construction
of the Bindley Bioscience Center which was part of the largest gift
by an individual in Purdue University
history. He is also the former owner of the Indiana Pacers
Professional Basketball Team.
Bruce E. Terker
Mr.
Terker is a Founding Partner of a number of private equity and
alternative asset management firms which include Odyssey Capital
Group, Ballyshannon Partners and Argosy Capital. Mr. Terker
is on the advisory board of The Rodney L White Center for Financial
Research at the Wharton School at the University of Pennsylvania, as well as the founder
and benefactor of the Marshall Blume Prizes in Investment Research.
Mr. Terker was a co-founder and Partner in Geewax, Terker, and
Company, a registered investment advisor that managed over
$8 billion and which catered to the
institutional investor marketplace for over 25 years. He has
extensive experience investing in the Life Sciences and
Biopharmaceutical Industries. Mr. Terker previously taught courses
in Investments and Corporate Finance at the Wharton School and has
been published in the Journal of Finance for his research in
capital market theory and asset pricing.
About Special Protocol Assessment (SPA)
A SPA is a
process in which sponsors may ask to meet with the FDA to reach
agreement on the design and size of certain clinical trials to
determine if they adequately address scientific and regulatory
requirements for a study that could support marketing approval. Our
SPA agreement for the above-referenced study indicates concurrence
by the FDA with the adequacy and acceptability of specific critical
elements of overall protocol design for the study, which we intend
to support a future Biologic License Application (BLA).
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. Certain risk factors in conjunction with
natural wear and tear lead to the breakdown of cartilage. OA 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 Ampion, our product candidate, to
treat prevalent inflammatory conditions for which there are limited
treatment options.
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
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.