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This material contains estimates and forward looking statements, as defined by the Private Securities Litigation Reform Act of 1995. The words "believe," "may," "might," "will," "aim," "estimate," "continue," "would," "a

Key Takeaway: material contains estimates and forward looking statements, as defined by the Private Securities Litigation Reform Act of 1995. The words "believe," "may," "might," "will," "aim," "estimate," "continue," "would," "anticipate," "intend," "expect," "plan" and similar words are i

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material contains estimates and forward looking statements, as defined by the
Private Securities Litigation Reform Act of 1995. 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 several 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: our expectations regarding our revenues, expenses, effective tax
rates and other results of operations; our ability to obtain FDA approval of our
product candidates; our anticipated capital expenditures and our estimates
regarding our capital requirements; our liquidity and working capital
requirements; our need to obtain additional funding and our ability to obtain
future funding on acceptable terms; our product candidates and plans to
promote them; anticipated trends and challenges in our business and in the
markets in which we operate; our ability to retain and hire necessary employees
and to staff our operations appropriately; our ability to find future
acquisition opportunities on favorable terms or at all and to manage any
acquisitions; our ability to compete in our industry and innovation by our
competitors; our ability to stay abreast of 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; and the
future trading prices of our common stock and the impact of securities analysts'
reports on these prices. 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.
Phase III company focused exclusively on gastroenterology (GI): ie: anal
disorders, a neglected area of drug development Our products address large
markets where there are no FDA approved drugs in the US 3 Late stage
products: Phase III - Hemorrhoids Phase III initiated - Anal fissures
Phase IIb - Fecal incontinence Near term milestones with 2 important data
read outs expected in H1 2012 Multiple scenarios are possible for
development and commercialization after H1 data readouts
Management Team Russell H. Ellison, MD, MSc: Chief Executive Officer and
Chairman of the Board 30 yrs experience in pharmaceutical industry, most
recently: EVP, Paramount Biosciences (2007-2010) VP Clinical
Development, Fibrogen Inc (2005-2007) VP Medical Affairs and CMO,
Sanofi-Synthelabo US (2002-2005) VP Medical Affairs and CMO, Roche US
(1997-2002) Prior Board Chairman, Cormedix Inc Prior board member of Cougar
Inc David J. Barrett, CPA: Chief Financial Officer CFO, NeuroHitech, a
public pharma company with development stage and marketed products (2006-2009)
CFO, Overture Asset Managers & Overture Financial services (hedge fund)
(2003-2006) Manager Deloitte & Touche (1999-2003)
Development Team Monil Shah PharmD: VP Clinical Research Novartis,
Amgen, Fibrogen, Celgene Celine Scholl CPM Novartis
Merck,GSK Mohan Kabadi PhD: Head of Product Development &
Manufacturing > 20 years; BMS, Novartis, Faulding, Roche John
Dietrich PhD Preclinical Development (toxicology) > 30 years
Iferanserin Novel Treatment for Hemorrhoids
Iferanserin Hemorrhoid Overview Symptoms Causes Bleeding, pain,
itch, swelling & Increased hydrostatic pressure = AV tenderness,
difficult defecation dilation, slower blood flow Market Serotonin
activation of 5HT2a receptors Efferent vasoconstriction,
platelet ~12.5 mm patients in US aggregation, further dilation and
Highest prevalence >50 years of age symptoms No FDA approved products in
U.S. and current products are not reimbursed 4 mm prescriptions written
annually in the U.S. for unapproved use in hemorrhoids 22 mm OTC units sold
annually in the U.S. No other known drugs in development in the
Iferanserin Product Overview Topical rectal ointment: applied
intra-anal BID (with applicator) Mechanism NCE - potent 5HT2a
antagonist : Does not cross the blood brain barrier except at doses much
higher than to be used therapeutically Selective for 5HT2a; 1/3 affinity for
5HT2c, very low affinity for 5HT2b (antagonist) and 1/1000 affinity for
other 5HT receptors Low systemic exposure: < 10% bioavailability
(rat) Indication Acute treatment of hemorrhoids Intellectual
Property: Licensed from the inventor Patents issued in all major
territories US COM patent expires 2015, Hatch-Waxman exclusivity 5 yrs (Rx
to OTC switch) New concentration range patent just filed; 20 yrs
exclusivity: prevents A/B rated generics Topical GI product with low
bioavailability : generic substitution potentially difficult
Iferanserin Ready for Phase III Phase II completed -Excellent
safety profile 7 clinical trials, 220 patients exposed to VEN 309 Side
effects are local and minor; systemic side effects comparable to placebo No
SAE's, no deaths Development plan: chronic use drug FDA confirmed PH
III status; agreement on primary endpoint 1500 patient safety database ; in
2 pivotal trials or 2 pivotals and 1 safety study (TBD) 104 wk 2 species
carcinogenicity (no prior findings of concern) is critical path to NDA filing
(2014) Clinical pharmacology program 2 pivotal trials (Phase III) to
be done in series, not on critical path SPA agreement expected March/April
Iferanserin 1st Pivotal Phase III Study: Proposed Design Start
mid-2011, double blind data available Q1 2012 400 patients Double
Blind; 0.5% iferanserin vs placebo ointment 60 sites (North America) 14 days
treatment with follow up at 28 days All patients roll to active treatment
after 28 days, with 12 month follow up to assess recurrence (open
label) Inclusion criteria Symptomatic grade I to III internal
hemorrhoids Bleeding from hemorrhoids 2 consecutive days prior to
randomization, with pain or itching accompanying the bleeding for the 2
days Primary endpoint: time to cessation of bleeding for a minimum of 3
days Secondary endpoints: cessation of pain and itching for 3
Last updated: Feb 14, 2011