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Ventrus Biosciences Announces Positive Results From Clinical Dermal Safety and Pharmacokinetic Studies of Diltiazem (VEN 307)



Ventrus Biosciences Announces Positive Results From Clinical Dermal Safety and
Pharmacokinetic Studies of Diltiazem (VEN 307)

Results From Second Pivotal Phase 3 Trial in Anal Fissures Expected First
Quarter 2014

NEW YORK, Sept. 11, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc.
(Nasdaq:VTUS), a pharmaceutical company focused on developing and
commercializing gastrointestinal products, today announced positive results
from two clinical dermal safety studies and one pharmacokinetic (PK) study of
diltiazem hydrochloride 2% cream (VEN 307). All three studies were conducted
to support the Company's planned New Drug Application (NDA) for VEN 307 as a
treatment for anal fissures (AF).

For the dermal safety studies, Ventrus conducted two single-center,
randomized, controlled trials to evaluate the irritation and sensitization
potential of VEN 307 in healthy volunteers. The studies utilized cumulative as
well as repeat insult patch designs, which aim to provide a standard
assessment of cutaneous tolerability and safety. In these studies, results
demonstrated that VEN 307 was safe and well tolerated. Irritation and
sensitization caused by VEN 307 was similar to that seen with both placebo and
saline, and was significantly better than that seen with sodium lauryl sulfate
(SLS), the positive control. Minimal adverse events (AE) and no severe or
serious AEs were reported.

The Company also announced results from a pharmacokinetic (PK) study comparing
VEN 307 to oral diltiazem in subjects with anal fissure. All PK parameters,
including AUC, Cmax, Tmax and half-life, were consistent with expectations,
and results demonstrated that systemic exposure of VEN 307 was approximately
only 10% that of oral diltiazem, in line with prior data from an investigator
sponsored trial with this product, and confirming a potentially high safety
margin.

"These results mark another important step in our effort to develop and
commercialize VEN 307 as a treatment for anal fissures," said Russell H.
Ellison, M.D., M.Sc., Chairman and Chief Executive Officer of Ventrus
Biosciences, Inc. "With enrollment in our second, pivotal Phase 3 study moving
toward completion, we remain focused on conducting a high-quality trial with
the appropriate patient population and rigorous inclusion/exclusion criteria.
 We have added several new clinical sites in Europe to help expedite screening
and enrollment, and now expect to complete enrollment near the end of this
year, with data expected in the first quarter of 2014. Based on our
anticipated timeline, we believe we remain sufficiently capitalized to support
operations through a potential launch of VEN 307."

VEN 307 is currently being studied in a second pivotal trial, a Phase 3b,
randomized, double-blind, placebo-controlled, parallel-treatment group,
multicenter efficacy and safety study in subjects with AF (VEN307-AF-001). The
study is expected to enroll 400 subjects at approximately 140 clinical sites
in the U.S., Europe, Canada, and Israel.  The 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 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.

Results from this ongoing pivotal Phase 3 study of VEN 307 are expected in the
first quarter of 2014 and, assuming a successful outcome, Ventrus expects to
file an NDA in the second quarter of 2014.

Ventrus reported positive results in 2012 from its first pivotal Phase 3,
randomized, double-blind, placebo-controlled clinical trial of VEN 307 for the
treatment of AF. The trial randomized 465 subjects to diltiazem hydrochloride
4% or 2% w/w cream, or placebo, applied topically three times daily (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.

Dermal Safety and PK Study Design Details

The clinical dermal irritation study was conducted in 30 subjects using 0.2 g
of diltiazem hydrochloride 2% cream, 0.2 g placebo cream, 0.2 mL of solution
of 0.2% SLS as positive control, and 0.2 mL of 0.9% saline as negative control
applied topically under occlusive patch conditions to the infrascapular area
of the back, once daily for 21 consecutive days. AE data was collected
throughout the duration of the study.

The clinical dermal sensitization study was conducted in 200 subjects using
0.2 g of diltiazem hydrochloride 2% cream, 0.2 g placebo cream, 0.2 mL of
solution of 0.1% SLS as positive control, and 0.2 mL of 0.9% saline as
negative control applied topically 3 times weekly for 21 days (9 applications)
during the Induction Phase, and one time at Challenge (10 times in total). AE
data was collected throughout the duration of the study.

The clinical PK study was an open-label, single- and multi-dose study
comparing VEN 307 to single-dose oral diltiazem in subjects with anal
fissure. Twelve subjects were enrolled in this study which evaluated AUC,
Cmax, Tmax, and half-life.

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 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 Ventrus

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 in November 2010, and reported positive top line results in May
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: 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
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