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Ventrus Biosciences Completes Enrollment of Second Pivotal Phase 3 Trial of Diltiazem Cream (VEN 307) in Patients With Anal

Ventrus Biosciences Completes Enrollment of Second Pivotal Phase 3 Trial of
Diltiazem Cream (VEN 307) in Patients With Anal Fissure

Results Expected First Quarter 2014; NDA Filing Expected to Occur in Second
Quarter 2014

NEW YORK, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc.
(Nasdaq:VTUS) announced that it has completed patient enrollment and
randomization in the second Phase 3 clinical trial of Diltiazem Hydrochloride
2% Cream (VEN 307) in patients with pain related to anal fissure (AF). Ventrus
anticipates that data from this Phase 3 study will be available in the first
quarter of 2014, and it expects to file a New Drug Application (NDA) for VEN
307 in the second quarter of 2014.

The second pivotal Phase 3 trial, a randomized, double-blind,
placebo-controlled, parallel-treatment group, multicenter efficacy and safety
study of VEN 307 in subjects with AF, enrolled 434 subjects and is being
conducted at 90 global clinical sites, with the majority of sites and patients
located in the United States. Enrollment into this trial began in October
2012.

The study's primary objective is to evaluate the efficacy of VEN 307 on
reduction of worst AF-related pain associated with or following defecation
when administered three times a day (TID) for 28 days. The secondary
objectives are to evaluate the effect of VEN 307 on reduction of overall daily
AF-related pain and to evaluate patient global impression of improvement
(PGI-I) at Day 29 in subjects with AF-related pain.To be eligible for
randomization into the study, all patients had to have sufficient baseline
AF-related pain associated with or following defecation of ≥ 5 on an 11-point
numerical rating score (NRS) scale with 0 being no pain and 10 being the worst
possible pain.

"This is an important milestone in the clinical development of VEN 307, and
marks completion of enrollment in the second of two pivotal clinical trials
for the treatment of anal fissures," said Dr. Russell Ellison, Chairman and
Chief Executive Officer of Ventrus Biosciences, Inc. "Ventrus is focused on
bringing the treatment of anal fissures into the modern medical era by
developing the first non-nitroglycerin prescription pharmaceutical treatment
for FDA approval, an advancement which could benefit patients who suffer from
this extremely painful condition."

In May 2012, Ventrus reported that its first pivotal Phase 3, randomized,
double-blind, placebo-controlled clinical trial of VEN 307 for the treatment
of anal fissures met its endpoints. The trial randomized 465 subjects to
diltiazem hydrochloride 4% or 2% w/w cream, or placebo, applied topically TID
for 8 weeks, followed by a 4 week blinded observation period.At 4 weeks, the
2% diltiazem treatment arms demonstrated improvements compared to placebo in
the primary endpoint of average of worst anal pain associated with or
following defecation (pain score improvement of 0.43, p=0.0122) and in the
secondary endpoints of overall anal-fissure-related pain (pain score of 0.42,
p=0.0143).Pain endpoints were assessed using an 11-point numerical pain
rating scale (Likert-like scale).

Because diltiazem is approved in oral formulations for the treatment of angina
and high blood pressure, VEN 307 is eligible for the FDA's 505(b)2
registration pathway.

About VEN 307: Diltiazem Hydrochloride Cream

Diltiazem hydrochloride is a calcium-channel blocker that has been marketed in
oral formulations for the treatment of angina and high blood pressure for over
two decades. Diltiazem hydrochloride cream is applied perianally to treat pain
related to anal fissure. It has been shown to normalize internal anal
sphincter pressure and reduce anal maximal resting pressure, or MRP, and its
vasodilator activity has the potential to improve blood supply, thereby
decreasing the pain associated with anal fissures.

About Anal Fissures

Anal fissure is a tear in the lining of the anal canal characterized by severe
anal pain associated with or after bowel movements. It is a common anal
disorder, which we believe is underdiagnosed. 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 healing.

In 2010, it was estimated by SDI Health LLC that there were approximately 1.1
million office visits per year for anal fissures. Topical diltiazem, which is
not approved by the FDA as a use for anal fissure, is currently listed in the
U.S. anal fissure treatment guidelines as a preferred agent prior to
attempting surgery, and is available only as a compounded medicine.

About Ventrus

Ventrus is a specialty pharmaceutical company primarily focused on the
development and commercialization of prescription drugs addressing
gastrointestinal problems.The Company's lead product, topical diltiazem (VEN
307) for the treatment of anal fissures, reported positive top line results in
May 2012. The second Phase 3 trial has now completed enrollment and is
expected to report out data in the first quarter of 2014, with a NDA filing
expected in the second quarter of 2014. Ventrus' product candidate portfolio
also includes topical phenylephrine (VEN 308) intended to treat fecal
incontinence.The Company has also recently licensed intellectual property and
know-how relating to the oral delivery of bacteria, viruses and drugs to
specific sites in the intestine, using a pH sensitive controlled release
platform technology.The potential indication areas include (i)
gastro-intestinal, auto-immune and metabolic disorders, (ii) viral and
bacterial vaccines, and (iii) optimized colonic delivery of drugs.

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: 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 the FDA
and 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 the Securities and Exchange Commission.

CONTACT: Ventrus Biosciences, Inc.
         David Barrett
         646-706-5208
         dbarrett@ventrusbio.com
        
         Argot Partners
         David Pitts
         212-600-1902
         david@argotpartners.com