Ampio Receives FDA Acceptance of its Patient Outcome for Premature Ejaculation (POPE) Questionnaire, Paving the Way for its US

Ampio Receives FDA Acceptance of its Patient Outcome for Premature Ejaculation
  (POPE) Questionnaire, Paving the Way for its US Pivotal Trial on Zertane™

PR Newswire

GREENWOOD VILLAGE, Colo., March 11, 2013

GREENWOOD VILLAGE, Colo., March 11, 2013 /PRNewswire/ --Ampio
Pharmaceuticals, Inc. (NASDAQ:AMPE), a biopharmaceutical company developing
drugs to treat prevalent inflammatory diseases, such as osteoarthritis
(Ampion™) and diabetic macular edema (Optina™) and sexual dysfunction
(Zertane™) announced FDA acceptance of its POPE questionnaire, a modification
of the Premature Ejaculation Profile (PEP) questionnaire that was used in the
two successful Zertane™ Phase 3 clinical trials completed in Europe.


Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained,"This unique
evaluation tool, named Patient Outcome for Premature Ejaculation (POPE), was
tested in a clinical trial to assure the FDA's SEALD division that the verbal
responses of the patients to physician questions following their treatment
would accurately reflect their clinical response to the drug. The successful
completion of this trial and acceptance of the POPE by the FDA allows Ampio
(or a pharmaceutical partner) to file an IND in the USA for a pivotal trial of
Zertane™ with POPE as a co-primary end-point along with Intravaginal
Ejaculatory Latency Time (IELT). This critically important improvement of the
clinical trial protocol has occupied the company for the last seven months and
we are grateful to the FDA for its assistance and guidance during this facet
of the regulatory path."

Michael Macaluso, Ampio's CEO, noted that "Ampio will be the sole owner of the
POPE, the only FDA accepted outcome measure of efficacy of treatment for PE
and a requirement by the FDA for any clinical trial evaluating treatment of PE
together with the other co-primary end-point, Intravaginal Ejaculatory Latency
Time (IELT). The Zertane™ pivotal trial in the USA is estimated to cost less
than $4 million. The drug has already been manufactured and ready for the
trial. The CMC created for Zertane™ is also being submitted to the TGA (the
Australian FDA) as the last piece for registration of Zertane™ in Australia."

Mr. Macaluso further noted, "The Ampio sexual dysfunction portfolio also
includes Zertane-ED™, a combination of Zertane™'s active ingredient with an
erectile dysfunction drug to treat comorbid PE and Erectile Dysfunction (ED).
Men with ED suffer from PE about 30% of the time. Zertane-ED™ is under
development by Ampio and has been formulated so that the peak activities of
its two components (PE and ED) are synchronous. Ampio was awarded multiple
patents on the combinations of Zertane™ with any PDE5 inhibitors.
Additionally, Daewoong Co. Ltd,  our South Korean partner,  has agreed to
finance and conduct the first clinical trial on Zertane-ED™ in Korea in
compliance with FDA requirements. With everything in place for Zertane™ and a
very low cost pivotal trial, all options are open to us and we can make the
best possible decision for our shareholders."

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
rapid development of therapies to treat prevalent inflammatory conditions for
which there are limited treatment options. It aims to provide medicines to
improve the health and quality of life of patients with minimal side effects.
Ampio is developing compounds that decrease inflammation by 1) inhibition of
specific pro-inflammatory compounds by affecting specific pathways at the
protein expression and at the transcription level or 2) activation of a
specific phosphatase or depletion of the available phosphate needed for the
inflammation process and 3) decreasing vascular permeability/leakage, an
upstream event in inflammation. For more information visit:

Forward Looking Statement

This press release includes forward-looking statements within the meaning of
Section27A of the Securities Act of 1933, as amended, and Section21E of the
Securities Exchange Act of 1934, or the Exchange Act. All statements other
than statements of historical facts contained in this press release, including
statements regarding our anticipated future clinical and regulatory events,
future financial position, business strategy and plans and objectives of
management for future operations, are forward-looking statements. Forward
looking statements are generally written in the future tense and/or are
preceded by words such as "may," "will," "should," "forecast," "could,"
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variations on such terms or comparable terminology. Such forward-looking
statements include, without limitation, statements regarding the potential
future commercialization of our product candidates, the anticipated start
dates, durations and completion dates, as well as the potential future
results, of our ongoing and future clinical trials, the anticipated designs of
our future clinical trials, anticipated future regulatory submissions and
events, our anticipated future cash position and future events under our
current and potential future collaborations. These forward-looking statements
are subject to a number of risks, uncertainties and assumptions, including
without limitation the risks described in "Risk Factors" in PartI, Item1A of
Ampio's Annual Report. These risks are not exhaustive. Other sections of this
Annual Report include additional factors that could adversely impact our
business and financial performance. Moreover, we operate in a very competitive
and rapidly changing environment. New risk factors emerge from time to time
and it is not possible for our management to predict all risk factors, nor can
we assess the impact of all factors on our business or the extent to which any
factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. You should
not rely upon forward-looking statements as predictions of future events. We
cannot assure you that the events and circumstances reflected in the
forward-looking statements will be achieved or occur and actual results could
differ materially from those projected in the forward-looking statements. We
assume no obligation to update or supplement forward-looking statements.

Investor Contact:
Rick Giles
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct (720) 437-6530

SOURCE Ampio Pharmaceuticals, Inc.

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