8-K

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): November 5, 2012

VENTRUS BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-35005	20-8729264
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer ID Number)

99 Hudson Street, 5th Floor, New York, New York	10013
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code (646) 706-5208

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:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ 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 November 5, 2012, Ventrus Biosciences, Inc. issued a press release announcing that it had received written feedback from the U.S. Food and Drug Administration regarding its planned new drug application, or NDA, for diltiazem hydrochloride cream (VEN 307) in anal fissures and that, following completion of the recently begun Phase 3 clinical trial, it expects to file the NDA late in the fourth quarter of 2013. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Attached hereto as Exhibit 99.2, and incorporated herein by reference, is a PowerPoint presentation that Ventrus will present on its call scheduled for 10:00 a.m., Monday, November 5, to discuss VEN 307.

Item 9.01. Financial Statements and Exhibits.

(d)	Exhibits
	Exhibit No.	Description
	99.1	Press release dated November 5, 2012.
	99.2	PowerPoint presentation of November 5, 2012.

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.

	VENTRUS BIOSCIENCES, INC.
Date:  November 5, 2012	/s/ David J. Barrett
	David J. Barrett, Chief Financial Officer

EX-99.1

Exhibit 99.1

 

VENTRUS BIOSCIENCES RECEIVES FDA WRITTEN FEEDBACK, TARGETS NDA FILING FOR DILTIAZEM (VEN 307) IN ANAL FISSURES FOLLOWING
SECOND PHASE 3 STUDY

NDA Filing Expected to Occur in Fourth Quarter 2013

Company to Host Conference Call and Presentation Today, November 5, at 10:00 a.m. ET

NEW YORK, November 5, 2012 -- Ventrus Biosciences, Inc. (Nasdaq:VTUS) a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced that, following the receipt of written feedback from the U.S. Food and Drug Administration (FDA), the Company expects to file a new drug application (NDA) for diltiazem hydrochloride cream (VEN 307) in anal fissures following completion of a second Phase 3 study. Ventrus has started to enroll in its second Phase 3 pivotal trial, with results expected early fourth quarter 2013, and assuming a successful outcome, expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014. Ventrus also received specific guidance on the remaining toxicology programs, clinical cutaneous safety studies, and PK study required for the NDA and all programs are underway.

The second pivotal Phase 3 trial, a Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects with Anal Fissure, is planned to enroll 400 subjects at approximately 120 clinical sites in the U.S., Canada, and Israel. The primary objective is to evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure-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 diltiazem hydrochloride cream 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.

“As we anticipated, the FDA has guided that an additional study of VEN 307 in patients with anal fissures will be required to be part of our planned NDA," said Russell H. Ellison, M.D., M.Sc., Chairman and Chief Executive Officer of Ventrus Biosciences, Inc. "We expect that the second study will allow us to confirm the positive results from the first pivotal Phase 3 study, and may enable us to expand our product label to include reduction in average daily pain in addition to pain on defecation We look forward to bringing VEN 307, as expeditiously as possible, to those suffering from anal fissures."

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 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.

Conference Call and Presentation

The Company is hosting a conference call today, November 5, at 10:00 a.m. Eastern Time. To participate on the call, interested parties may dial 1-888-330-6585 (Toll-Free/North America) or 1-253-237-1143 (International/Toll) and use Conference ID: 64537164 to register ten minutes before the call is scheduled to begin. The call and an accompanying presentation will be broadcast live on the internet at http://www.ventrusbio.com.

The call will be archived for replay on November 5 at 1:00 p.m. Eastern Time and will remain available until November 12. The replay can be accessed at 1-855-859-2056 (Toll-Free/North America) or 1-404-537-3406 (International/Toll) using Conference ID: 64537164. An audio replay of the call will also be available on the Company's website, http://www.ventrusbio.com, for 30 days after 1:00 p.m. Eastern Time, November 5.

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. 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 healing.

In 2010, it was estimated by SDI Health LLC that there were approximately 1.1 million office visits per year for 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 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

EX-99.2

Exhibit 99.2

1 This material contains estimates and forward - looking statements. The words “believe,” “may,” “might,” “will,” “aim,” “estimate,” “continue,” “would,” “anticipate, ”“intend,” “expect,” “plan” and similar words are intended to identify estimates and forward - looking statements. Our estimates and forward - looking statements are mainly based on our current expectations and estimates of future events and trends, which affect or might affect our businesses and operations. Although we believe that these estimates and forward - looking statements are based upon reasonable assumptions, they are subject to many risks and uncertainties and are made in light of information currently available to us. Our estimates and forward - looking statements may be influenced by the following factors, among others : risks related to the design, costs, timing, regulatory review and results of our studies and clinical trials; our ability to obtain FDA approval of our product candidates; differences between historical studies on which we have based our planned clinical trials and actual results from our trials; our anticipated capital expenditures, our estimates regarding our capital requirements, and our need for future capital; our liquidity and working capital requirements; our expectations regarding our revenues, expenses and other results of operations; the unpredictability of the size of the markets for, and market acceptance of, any of our products; our ability to sell any approved products and the price we are able realize; our need to obtain additional funding to develop our products, and our ability to obtain future funding on acceptable terms; our ability to retain and hire necessary employees and to staff our operations appropriately; our ability to compete in our industry and innovation by our competitors; our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business; estimates and estimate methodologies used in preparing our financial statements; the future trading prices of our common stock and the impact of securities analysts’ reports on these prices; and the risks set out in our filings with the SEC, including our Annual Report on Form 10 - K and our Form 10 - Q for the quarter ended June 30, 2012. Estimates and forward - looking statements involve risks and uncertainties and are not guarantees of future performance. As a result of known and unknown risks and uncertainties, including those described above, the estimates and forward - looking statements discussed in this material might not occur and our future results and our performance might differ materially from those expressed in these forward - looking statements due to, including, but not limited to, the factors mentioned above. Estimates and forward - looking statements speak only as of the date they were made, and, except to the extent required by law, we undertake no obligation to update or to review any estimate and/or forward - looking statement because of new information, future events or other factors. Forward Looking Statements

» A Gastroenterology Phase III biopharmaceutical company focused on bringing 505b2 products to market for unmet needs, especially in the area of anal disorders - a neglected area of drug development. » Current Portfolio  VEN 307 – Phase III data for first pivotal program showed good tolerability, significant improvement in efficacy outcomes for anal fissures  Critical mass market focused in gastroenterologist and colorectal surgeons  Significant lifecycle opportunities  VEN 308 – Proof of concept in fecal incontinence associated with Ilea Pouch Anal Anastomosis (IPAA)  Orphan disorder treated in ~ 40 CRS centers nationwide  Significant expansion opportunity » Funded through key milestones  Sufficient cash and cash equivalents for approval of VEN 307 2 Company Overview

Pipeline 3 Program (Pathway) Indication ClinicalPhase Potential NDA Filing Commercial Rights I II III VEN 307* Diltiazem (505(b)2 ) Anal Fissures 2013 North America VEN 308 (505(b)2) Fecal Incontinence 2015 North America Late Stage Pipeline with Data - Validated Phase III Candidate and Phase IIb Ready Candidate with POC in Orphan Indication *Phase III data released May 14, 2012

VEN 307: Diltiazem Cream Novel Treatment for Anal Fissures

5 Anal Fissures: Cause and Management Increased sphincter tone Local ischemia Tear (fissure) in anal canal Cause Severe pain on defecation Treatment options Control constipation, topical steroids Reduce sphincter tone Compounded Topical drugs: • GTN* • diltiazem Botox Surgery Sphincters (muscles) Anal fistula *Rectiv (topical GTN) recently approved by FDA, launched 3/2012 by Aptalis Anal fissure 1.1 million office visits/year

6 VEN 307 (diltiazem) Summary 2% topical diltiazem cream applied peri - anally TID Mechanism of Action » Calcium channel blocker  Relaxes the internal anal sphincter, reducing pain and increasing tissue blood flow Preclinical Safety » Preclinical topical safety with 2% diltiazem twice daily for ninety days Clinical Pharmacology » Topical has < 10% systemic exposure as oral dose but significantly greater effect on sphincter tone – i.e., blood levels do not predict activity. Low exposure = better tolerability than oral diltiazem Clinical Data » Numerous clinical trials with ~1,200 subjects » Infrequent mild adverse events (AE) reported » Similar or better reduction in pain, significantly better tolerability than with nitroglycerin (GTN) » 1 ST pivotal complete: 465 subjects, significant improvement vs placebo, tolerability confirmed

FDA Written Feedback from Pre - NDA meeting Aug 30 2012 » Planned NDA submission following completion of second Phase 3 study (expected early 4 th quarter 2013) » Overall Phase 3b study design accepted (1 st patient randomized)  Randomized, Double - Blind, Placebo - Controlled, Parallel - Treatment Group Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects with Anal Fissure,  400 subjects at approximately 120 clinical sites in the U.S., Canada, and Israel  Primary endpoint is reduction of worst anal fissure - related pain associated with or following defecation when administered three times a day for 28 days  Secondary endpoints are reduction of overall daily AF - related pain and patient global impression of improvement (PGI - I) at Day 29 in subjects with AF - related pain » NDA to include clinical cutaneous sensitization and irritation studies and PK study » Indication is not considered to be chronic 7

Summary of 1st Phase III Results (May 14, 2012) » Double - blind, placebo - controlled clinical 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 arm demonstrated improvements compared to placebo:  In the primary endpoint of average of worst anal pain associated with or following defecation (pain score improvement 0.43 , p=0.0122, 2 %);  In the secondary endpoint of overall anal - fissure - related pain (0.42, p=0.0143, 2 %); and » Compared with placebo, 2% diltiazem significantly improved the Patient’s Global Impression of Improvement measure at Week 4 (p = 0.0084) » At Week 8, healing was improved for the 2% diltiazem arm compared to placebo, with 31.2% (p = 0.0426) versus 23.9% showing healing » Adverse events similar in 3 arms (4%, 2%, placebo) 8

Multiple Major Milestones Expected Over Next 18 Months 9 2nd Phase 3 Trial Q3 - 12 Q4 - 12 Q1 - 13 Q2 - 13 Q3 - 13 Q4 - 13 FDA Meeting NDA Filing Cutaneous Safety Studies Expected PDUFA Date: November/December 2014 PK Studies

10 VEN 307 Life cycle management: BID Formulation » U.S. patent Feb 2018, HW extension to 8/2019; possible pediatric extension to Q2 2020. After this, we expect that generic approvals will be difficult (topical, trade secrets, re - formulation , will need clinical study and comparative PK in AF patients) » Have completed technical development of 4 extended release formulations: all patentable (exp. 2033), all B.I.D. or O.D.  Conduct 1 US PH III trial with 1 extended release formulation, if one is acceptable, in 2015, file NDA 2016/2017

COMPETITIVE POSITIONING » vs COMPOUNDED CALCIUM CHANNEL BLOCKERS: main target  Limited number of compounding pharmacies – VEN 307 widely available  Dr has to write a “recipe” vs a simple scrip for VEN 307  Concentration of compounded CCB’s is highly variable between pharmacies, prescriptions and within each tube – VEN 307 made to FDA standards  Patient has to pay (80$ - 200$/month) with no or very low assistance/reimbursement: Ventrus will provide copay coupons to get patient out - of - pocket costs to < 50$ » vs RECTIV or compounded nitroglycerin: second target  Nitro and CCB’s believed to be equally effective (Cochrane review 2012 & association guidelines)  Nitro has a very high rate of moderate to severe headaches: VEN 307 has no incremental side effects over placebo and is recommended as 1 st line by US surgery guidelines » vs Cortisone &/or Lidocaine: expansion opportunity  No evidence of safety or efficacy, no reimbursement for these products 11

VEN 307 - Diltiazem Cream 12 Prototypical Spec. Pharma Product Ideal First Product for Small Biotech Company Competitive Profile Lifecycle Opportunities Easily Self - Commercialized • DTZ is already preferred treatment for AF • Extensive literature & KOL supporting 1 st line use • Only approved competitor has rate limiting SE profile • Majority of AF treated by ~1,500 specialists • Critical mass within target market of >500k patients • Market within targeted physicians of $200 - 300M • Reduced dosing frequency with potentially patentable delivery technology • Future launch of i mproved metered dose packaging • Topical product with limited systemic exposure Additional Upside: Improve differential diagnosis of anal rectal disorders 12

13 Financials » Nasdaq (IPO 2011): VTUS » Cash balance  Cash and cash equivalents at June 30 th , 2012$ 29 Mil » Stock data  Fully diluted shares outstanding 15.3 Mil  Shares outstanding 12.4 Mil