UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): February 1,
2011
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VENTRUS
BIOSCIENCES, INC.
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||
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(Exact
name of registrant as specified in its charter)
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Delaware
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20-8729264
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer ID Number)
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787
7th
Avenue, 48th
Floor, New York, New
York 10019
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(Address
of principal executive
offices) (Zip
Code)
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Registrant’s
telephone number, including area code
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(212)
554-4300
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Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other Events.
On
February 1, 2011, Ventrus Biosciences, Inc., issued a press release announcing
the completion of its clinical development staffing. A copy of the
press release is attached hereto as Exhibit 99.1 and is incorporated herein
in its entirety by reference.
Item
9.01. Financial Statements and Exhibits.
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(d)
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Exhibits
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Exhibit
No.
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Description
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99.1
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Press
release dated February 1, 2011.
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2
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly
authorized.
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VENTRUS
BIOSCIENCES, INC.
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Date: February
1, 2011
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By:
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/s/ David J. Barrett | |
| David J. Barrett, Chief Financial Officer | |||
3
EXHIBIT
99.1
Ventrus
Completes Clinical Development Staffing
NEW YORK,
Feb. 1, 2011 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq:VTUS), a
pharmaceutical company focused on developing and commercializing
gastrointestinal products, today announced the completion of its clinical
development staffing.
Ventrus
has contracted Mohan Kabadi, Ph.D. as head of Pharmaceutical Product Development
and Manufacturing. Dr. Kabadi will be responsible for the supply of commercial
grade API and drug product for our products and for the development of the
extended release forms of Diltiazem cream. Previously, Dr. Kabadi was at
Bristol-Myers Squibb, Novartis, Pfizer, Faulding, and Roche. In the past 20
years, Dr. Kabadi has formulated, manufactured and successfully launched more
than 25 ethical, generic, and specialty products. Currently, he serves as the
President of American Association of Indian Pharmaceutical Scientists (AAiPS)
and holds membership as well as active participation in AAPS and
CRS.
Monil
Shah has been employed as Vice President, Clinical Research and Development. Dr.
Shah has a Doctorate in Pharmacy from Rutgers University and drug development
experience from Novartis, Amgen, Fibrogen, and most recently was Director of
Clinical Strategic Planning at Celgene.
Celina
Scholl has been employed as Clinical Project Manager. Ms. Scholl has drug
development experience from Novartis and Merck Pharmaceuticals and most recently
with GSK Biologics.
Christina
S. DiArcangelo, CEO of Armonia Clinical Research, has been contracted to manage
our outsourcing activities. Ms. DiArcangelo’s expertise includes
global outsourcing, project management, global contracting, site contracting,
process development, and site and service provider budget development and
negotiations.
John
Dietrich, formerly vice president of clinical operations of Ventrus and
currently consulting with Ventrus, will continue consulting with Ventrus, and
will manage our toxicology program and support our publication
activities. Dr. Dietrich received his Ph.D. in Pharmacology and has
been in the biopharmaceutical industry since 1979. Dr. Dietrich has held senior
management positions in drug research and development for a number of biotech
companies.
CEO
Russell Ellison commented on the completion of Ventrus clinical development
team: “We are very pleased to now be fully staffed with such a qualified and
experienced drug development team to help us optimally progress our exciting
product portfolio.”
About
Ventrus
Ventrus
is a development stage specialty pharmaceutical company focused on the
development of late-stage prescription drugs for gastrointestinal
disorders. Our lead product, Iferanserin (VEN 309) is a new chemical
entity, or NCE, for the topical treatment of hemorrhoids, which targets a
specific serotonin receptor (5HT2A) thought to be important in the disease. The
first late phase clinical trial (Phase III) with Iferanserin is expected to
start mid-year 2011 and we expect data to be available in the first quarter of
2012
Our
additional product candidate portfolio consists of two in-licensed late-stage
drugs intended to treat anal fissures (VEN 307) and fecal incontinence (VEN
308). The first Phase III clinical trial with Ven 307 has begun in Europe and we
expect data to be available in the second quarter of 2012. These candidates are
two molecules that were previously approved and marketed for other indications
and that have been formulated into our 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 retain and hire necessary employees and to
staff our operations appropriately; 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 cost, timing and results of clinical trials and other
development activities involving our product candidates; our anticipated capital
expenditures and our estimates regarding our capital requirements; 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
●
212-554-4506 ●
dbarrett@ventrusbio.com