Elis is the license holder of Vitaros for the Middle East

[Pages:37]Elis is the license holder of Vitaros for the Middle East

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Topical Treatment for Erectile Dysfunction

Health"Canada"&"European"Health"Authorities"granted" marketing"approval"for"Vitaros?"as"a""

FIRST"LINE0THERAPY#FOR#ERECTILE#DYSFUNCTION## for#entire#patient#population#including#non"PDE5#patients#

Vitaros Marketed in the following countries ? By Takeda in the United Kingdom - June 2014 ? By Novartis-S/ Hexal in Germany, Sweden & Belgium in 2014 ? By Majorelle Laboratory in France in 2015 ? By BRACCO in Italy in 2015

Vitaros?#is"the"right"treatment"for"the"ED"

Unmet#Needs#

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VITAROS?##

1As of 12 Feb 2013 2As of 31 Dec 2012

health and dermatology. With a strong pipeline, multiple late-stage product candidates, and operations in both the US and Europe (France), Apricus Bio

Near-Term Value Drivers

generates revenues and value by developing and out-

licensing its pipeline products and promoting products

Topical#alprostadil/DDAIP## Commence sales of Vitaros? in Canada by Abbott Labs in the first half of 2013

in France.

Key Assets

for#the#Treatment#of#Erectile#Dysfunction # European approval decision of Vitaros? expected in the first half

# Vitaros? (alprostadil 0.3% topical cream) is approved

in Canada for the treatment of erectile dysfunction.

of 2013

Vitaros? is a topically applied vasodilator that

Vitaros is the first approved topical prescription drug for impotence

Additional Vitaros? partnerships for emerging markets

Regulatory and clinical design plan communicated for Femprox? in the US, Europe, and Canada in first half of 2013

increases blood flow to the penis, causing an erection within minutes, much faster than can be achieved from oral medications. Also unlike oral medications, Vitaros? can be safely used by erectile dysfunction patients with hypertension, diabetes, cardiovascular issues, or patients on alpha blockers or beta blockers. Erectile dysfunction affects approximately 140 million men worldwide and represents an estimated $2.6

billion in annual revenue, excluding the US.

? Cold Chain (2?C -8?) Second Generation

? 7 Days Room Temp Room Temperature Available in 2016

? Shelf Life 18 Month

? Room Temperature Femprox? (alprostadil 0.4% topical cream) is a product candidate for the treatment of female sexual arousal disorder (FSAD). Seven clinical studies have been

? Expected 24-36 month shelf life successfully completed to date, including one, 98subject Phase II study in the US and a nearly 400-

? Key driver of market growth subject Phase III study in China. To date, no product has been approved in the U.S. to treat FSAD, a persistent or recurring inability to attain or maintain and expansion adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.

Apricus Biosciences, Inc. ? 11975 El Camino Real, Suite 300, San Diego, CA 92130 ? 858.222.8041 ?

?"Topical"cream,"high"viscosity""" ?"Prostaglandin"E1,"potent"vasodilator" ?"Rapid"onset"(generally"5E30"minutes)"" ?"Significant"efficacy,"including"difficult"to"treat""" populations"

?"Diabetic#patients# ?#Hypertensive#patients# ?#Patients#with#cardiac#issues# ?#Patients#on#nitrates#and#alpha#blockers# ?#Prostatectomy#patients## ?#Sildenafil#(Viagra?)#failures#

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? Side" effects" are" generally" mild," transient" and"topically"related"

? Studied"in"over"3,300"patients" ? Offers" first" choice/" first" line" option" in"

discussion" of" alternatives" with" ED" patients"

Strong#IP#Estate:## Issued" patents" through" 2026" and" patent" applications" filed" for" extended" protection" through"2032""

VITAROS?##

ESSM Career Award-Winner VITAROS? Jacques Buvant

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Award#Winner#

ESSM#2011#

AWARD#WINNER#

VITAROS?"Podium"Presentation"Named"Best# Clinical# Presentation# Award" 2011" (Male" Sexual"Disorder)"by"the"Scientific"Committee" of" the" Congress" for" the" ESSM" European" Society"of"Sexual"Medicine"Meeting"in"Milan."" " Efficacy# and# Safety" of" topical" alprostadil" Cream" (Vitaros?)" in" hypertensive," diabetic" and" cardiac" patients" with" male" erectile" dysfunction"(ED)"

VITAROS?##

Canada#Approval##

HEALTH CANADA

Nov."2010"

European#Decentralized# Approval#(10#Countries)#

World's#Approvals#

European#National#Phase#Approvals#in#

United Kingdom

June 2013

Spain

April 2014

Netherlands

Aug. 2013

Germany

Oct. 2013

France

Dec. 2013

Aug. 2013

Sweden

Aug. 2013

Ireland

Aug. 2013

Italy

Nov. 2013

Luxembourg

April 2014

Belgium

Jan. 2014

Also approved in August in Austria, Cyprus, the Czech Republic, Denmark, Finland, Greece, Iceland, Norway, Poland, Portugal, Romania and the Slovak Republic

VITAROS?##

Leading#Commercial#&## Development#Partners#

Partnerships throughout the world of Vitaros?

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Apricus"Bio"(NexMed"USA)"

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