Ventrus Biosciences Announces Poster Presentation on the Quality of Compounded Topical Diltiazem Hydrochloride Formulations for

Ventrus Biosciences Announces Poster Presentation on the Quality of Compounded
Topical Diltiazem Hydrochloride Formulations for Anal Fissure at the American
Pharmacists Association Meeting

Compounded Formulations From Retail Pharmacies Are Inaccurate in Respect to
Potency Approximately 50% of the Time and Lack Content Uniformity
Approximately 40% of the Time

NEW YORK, March 1, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc.
(Nasdaq:VTUS) today announced the poster presentation of the results from its
study investigating the quality of compounded topical 2% diltiazem
hydrochloride formulations for anal fissures at the American Pharmacists
Association Meeting currently underway in Los Angeles.

The use of topical 2% diltiazem hydrochloride for treating anal fissures has
been explored in multiple clinical trials since 2000. In 2004, the Standard
Practice Task Force of the American Society of Colon and Rectal Surgeons
(ASCRS) published revised practice parameters for managing anal fissure and
stated that topical formulations of calcium channel blockers may be
appropriately used to treat anal fissure and accorded this practice parameter
the highest level of evidence and highest grade of recommendation. Because no
commercially manufactured version of topical 2% diltiazem has been approved by
the US Food and Drug Administration (FDA) for treatment of anal fissure, colon
and rectal surgeons, gastroenterologists, and other physicians who want to
follow ASCRS practice parameters have to write prescriptions for a product
that will be extemporaneously compounded by retail pharmacies. To examine the
quality of compounded formulations of topical 2% diltiazem, Ventrus undertook
a high-performance liquid chromatography (HPLC) analysis of preparations
gathered from retail pharmacies in a metropolitan region.

A participating healthcare professional wrote 12 prescriptions, with 2 refills
allowed per prescription, so that 3 prescriptions could be filled at each of
12 pharmacies (36 total refills) for compounded 2% diltiazem cream. The
analysis included an assessment of potency (percentage of claim) and content
uniformity, with sampling from 8 different pre-specified locations within the
compounded formulation containers.

The United States Pharmacopoeia (USP) standard for potency is 90% to 115% of
claim. Of the 36 preparations, 5 (13.89%) were supra-potent and 13 (36.11%)
were sub-potent. The supra-potent prescriptions ranged in potency from 117.2%
to 128.5% of claim, and the sub-potent prescriptions ranged in potency from
34.8% to 89.8% of claim. Fourteen (38.9%) preparations lacked content
uniformity according to the USP standard.

"These results demonstrate that although compounded drugs might be formulated
under professional pharmacy standards, these standards are inherently less
rigorous than federal GMP quality standards," saidRussell H. Ellison, M.D.,
M.Sc., Chairman and Chief Executive Officer ofVentrus Biosciences,
Inc."Clearly, a topical 2% diltiazem cream produced under GMP regulations is
needed to avoid the large percentage of substandard compounded formulations of
a drug specifically recommended by the practice parameters of a medical

About Anal Fissures

Anal fissure is a tear in the lining of the anal canal. It is a common anal
disorder characterized by severe anal pain, associated with or after bowel
movements. The pathogenesis of anal fissure is hypothesized to be initiated by
the passage of a hard fecal bolus, resulting in a split in the epithelium of
the anal canal. Along with poor vascular supply of the anal epithelium,
increased activity (tone) of the internal anal sphincter smooth muscle further
compromises the anodermal blood supply and contributes to the pain and
ischemia of the anal epithelium, perpetuating ulceration and preventing

In 2010, it was estimated bySDI Health LLCthat there were approximately 1.1
million office visits per year for anal fissures.

AboutVentrus Biosciences

Ventrus is a development stage pharmaceutical company focused on the
development of late-stage prescription drugs for gastrointestinal problems,
specifically anal disorders. Our lead product is topical diltiazem (VEN 307)
for the treatment of anal fissures, for which the first Phase 3 trial was
initiated inNovember 2010, and reported positive top line results inMay
2012. The second Phase 3 trial began enrollment in the fourth quarter of 2012
and is ongoing. Our product candidate portfolio also includes topical
phenylephrine (VEN 308) intended to treat fecal incontinence. VEN 307 and VEN
308 are two molecules that were previously approved and marketed for other
indications and that have been formulated into our in-licensed proprietary
topical treatments for these new gastrointestinal indications.

Please Note: The information provided herein contains estimates and other
forward-looking statements regarding future events. Such statements are just
predictions and are subject to risks and uncertainties that could cause the
actual events or results to differ materially. These risks and uncertainties
include, among others: our ability to complete the offerings, including the
satisfaction of the closing conditions for each offering; the estimated
proceeds from each offering and our use of the anticipated proceeds from the
offerings; the components, timing, cost and results of clinical trials and
other development activities involving our product candidates; the
unpredictability of the clinical development of our product candidates and of
the duration and results of regulatory review of those candidates by
theFDAand foreign regulatory authorities; the unpredictability of the size
of the markets for, and market acceptance of, any of our products; our
anticipated capital expenditures, our estimates regarding our capital
requirements, and our need for future capital; our reliance on our lead
product candidate, VEN 307; our ability to retain and hire necessary employees
and to staff our operations appropriately; and the possible impairment of, or
inability to obtain, intellectual property rights and the costs of obtaining
such rights from third parties. The reader is referred to the documents that
we file from time to time with theSecurities and Exchange Commission.

CONTACT: Ventrus Biosciences, Inc.      
         David Barrett        
         Argot Partners        
         David Pitts       
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