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8-K - CURRENT REPORT - INNOVUS PHARMACEUTICALS, INC. | innv8k_jan82018.htm |
Exhibit 99.1
Innovus Pharma Enters Into License and Distribution Agreement with
Acerus Pharmaceuticals for the Commercialization of UriVarx®
in Canada
The Company to Receive an Upfront Payment and Minimum Order
Quantities at a Pre-Agreed Transfer Price Plus up to CAD$1.65
Million in Sale Milestone Payments
San
Diego, CA, January 8, 2018 – Innovus Pharmaceuticals, Inc.
("Innovus Pharma" or the “Company”) (OTCQB Venture
Market: INNV), an emerging
over-the-counter (“OTC”) consumer goods and specialty
pharmaceutical company engaged in the commercialization, licensing
and development of safe and effective non-prescription medicine and
consumer care products to improve men’s and women’s
health and vitality and respiratory diseases, today
announced that it has entered into an exclusive license and
distribution agreement with Acerus Pharmaceuticals Corporation, a
Canadian public company (TSX:ASP) (“Acerus”), for its
product UriVarx® in Canada. The Agreement with Acerus
represents one of the first international license and distribution
agreements for Innovus Pharma for one of its core multi-million
dollar U.S. products. Under the agreement, Innovus Pharma will
receive an up-front license payment and is eligible to receive up
to CAD$1.65 million dollars in sales milestone payments plus
minimum order quantities at an agreed-upon transfer
price.
UriVarx® is a Natural Health Product (NHP) approved by Health
Canada that helps reduce symptoms of hyperactive bladder such as
daytime urinary frequency, urgency and nocturia. The product will
be offered by Acerus over-the-counter to Canadians dealing with
such symptoms. Nearly 1 in 5 Canadians over the age of 35
experience overactive bladder symptoms1. Men and women’s lives are directly
impacted by an overactive bladder, and the current treatment
options may come with systemic side effects.
“We are very excited about this partnership with
Acerus,” said Dr. Bassam Damaj, the President and Chief
Executive Officer of Innovus Pharma. “They have a great
presence in the urology field in Canada, they maintain an active
dialogue with Canadian patients and they can leverage their
existing salesforce to effectively realize revenues from our core
product UriVarx®. We believe that UriVarx® is an
innovative NHP with a strong clinical data package that can become
a major product in the urology field in Canada.”
“Acerus is very happy to be working with Innovus on the
license and distribution of UriVarx® in Canada, “ said
Tricia Symmes, Chief Operating Officer of Acerus. “Since the
product is already approved by Health Canada, the Acerus team
expects to launch the product in the second half of 2018 and we
expect to potentially generate meaningful revenues this
year.”
About UriVarx®
UriVarx® is clinically proven to reduce urinary urgency,
accidents and both day and night frequency in Overactive Bladder
(“OAB”) and Urinary Incontinence (“UI”)
patients.
UriVarx® has undergone two double blind and comparative trials
in both male and female OAB and UI patients. The clinical results
include:
1.
Reduction
of ~56% in Urge Incontinence;
2.
Reduction
of ~66% in Stress Incontinence;
3.
Reduction
of ~61% in Urinary Urgency;
4.
Reduction
of ~33% in Urinary Frequency meaning the total average urinary
frequency was in the normal/ideal range after two months of use;
and
5.
Reduction
of ~46% in Nocturia.
According to the Simon Foundation, Urinary Incontinence affects 26
million Americans with a total market size of $1.1 billion (Source:
Medical Devices Inc.). The NAFC (National Association for
Continence) estimated that over 33 million Americans suffer from
Overactive Bladder with a market size over $2.1 billion (Source:
IMS Health).
The product is available in the U.S.
through www.urivarx.com and
through the Beyond Human® print and online
platforms.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging
OTC consumer goods and specialty pharmaceutical company engaged in
the commercialization, licensing and development of safe and
effective non-prescription medicine and consumer care products to
improve men’s and women’s health and vitality and
respiratory diseases. Innovus Pharma
delivers innovative and uniquely presented and packaged health
solutions through its (a) OTC medicines and consumer and health
products, which we market directly, (b) commercial partners to
primary care physicians, urologists, gynecologists and
therapists, and (c) directly to consumers through our on-line
channels, retailers and wholesalers. The Company is dedicated to
being a leader in developing and marketing new OTC and branded
Abbreviated New Drug Application (“ANDA”) products. The
Company is actively pursuing opportunities where existing
prescription drugs have recently, or are expected to, change from
prescription (or Rx) to OTC.
For
more information, go to www.innovuspharma.com;
www.zestra.com;
www.ejectdelay.com;
www.myvesele.com;
www.urivarx.com;
www.sensumplus.com;
www.myandroferti.com;
www.beyondhumantestosterone.com;
www.getbeyondhuman.com;
www.trybeyondhuman.com;
www.recalmax.com;
www.prostagorx.com;
www.fluticare.com;
www.allervarx.com;
and www.apeaz.com.
About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based
specialty pharmaceutical company focused on the development,
manufacture, marketing and distribution of innovative, branded
products that improve patient experience, with a primary focus in
the field of men’s and women’s health. Acerus
commercializes its products via its own salesforce in Canada,
and through a global network of licensed distributors in the U.S.
and other territories.
Acerus currently has two marketed products: ESTRACE®, a
product for the symptomatic relief of menopausal symptoms, is
commercialized in Canada; and NATESTO®, the first and
only testosterone nasal gel for testosterone replacement therapy in
adult males diagnosed with hypogonadism, is commercialized
in Canada and the U.S. In addition,
NATESTO® has been licensed for distribution in 30
countries worldwide. Marketing approvals in jurisdictions
outside of North America are expected to take place over
the course of the coming years. Acerus’ pipeline includes
three innovative product lines: GYNOFLOR™, an ultra-low dose
vaginal estrogen combined with a probiotic, for which a NDS has
been filed in Canada for the treatment of vaginal
atrophy, restoration of vaginal flora and treatment of certain
vaginal infections; TEFINA™, a clinical stage product aimed
at addressing a significant unmet need for women with female sexual
dysfunction; and ELEGANTTM,
a franchise comprised of ELEGANTTM
Vaginal Moisturizer, which provides
comfort to women suffering from vaginal dryness, and
ELEGANTTM
pH, which is a pH balanced vaginal
product. Finally, Acerus owns or has a license to numerous patents
relating to proprietary delivery systems as well as novel
formulations of products currently in the early stage of
development.
Acerus’
shares trade on TSX under the symbol ASP. For more information,
visit www.aceruspharma.com
and follow them on Twitter and
LinkedIn.
Innovus Pharma's Forward-Looking Safe Harbor:
Statements
under the Private Securities Litigation Reform Act, as amended:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may
individually or mutually impact the matters herein described for a
variety of reasons that are outside the control of the Company,
including, but not limited to, projected revenues from the
UriVarx® product in Canada if approved in that country,
estimated market for its products, and statements about achieving
its other development, growth, commercialization, financial and
staffing objectives. Readers are cautioned not to place undue
reliance on these forward-looking statements as actual results
could differ materially from the forward-looking statements
contained herein. Readers are urged to read the risk factors set
forth in the Company's most recent
filing on Form S-1, annual report on Form 10-K, subsequent
quarterly reports filed on Form 10-Q and other filings made with
the SEC. Copies of these reports are available from the SEC's
website or without charge from the Company.
###
References
1 http://www.canadiancontinence.ca/EN/overactive-bladder-vs-sui.php
Contact:
James
S. Painter III
Emerging
Markets Consulting, LLC
Tel:
407 340 0226
jamespainter@emergingmarketsllc.com