Innovus Pharmaceuticals, Inc. (OTCQB: INNV) -
Breaking News - January 24, 2018
Innovus Pharma Signs Exclusive License and Distribution Agreement with Lavasta
Pharma for ProstaGorx® in Certain Middle Eastern and North African Countries
The Company to Receive an Upfront Payment plus Transfer Price on Minimum Annual
Purchases Requirements
SAN DIEGO--January 24, 2018 -- Innovus Pharmaceuticals, Inc. (OTCQB:
INNV) ("Innovus
Pharma" or the “Company”), 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, announced today the signing of an exclusive license and distribution
agreement with Lavasta Pharma FZ-LLC, a company based in Dubai (“Lavasta”) for
the commercialization of ProstaGorx® in the Kingdom of Saudi Arabia, Algeria,
Egypt, the United Arab Emirates, Lebanon, Jordan, Kuwait, Morocco, Tunisia,
Bahrain, Oman, Qatar, and Turkey, among other countries. Under the agreement,
Innovus Pharma will receive an up-front license payment, will sell the products
to Lavasta at set supply prices and Lavasta has certain minimum annual purchase
requirements.
“We are pleased to expand our international exports of our products through the
introduction of our ProstaGorx® product in the Middle East and North Africa
regions through this partnership with Lavasta,” said Innovus Pharma CEO, Dr.
Bassam Damaj. “Lavasta is our 19h distribution partner for our products outside
the United States and represents our second major partnership to sell one of our
core U.S. products abroad,” said Innovus CEO Dr. Bassam Damaj. “This partnership
is one more step towards achieving our 2018 corporate goals for expanded revenue
and profitability from our many international distributors,” continued Dr. Damaj.
“We are excited to introduce ProstaGorx® to many countries throughout the Middle
East. We believe this product meets large unmet needs in the region and we look
forward to partnering with Innovus Pharma here through the use of our extensive
marketing channels and sales forces in these countries,” said Tara Banasi,
President of Lavasta.
About ProstaGorx® and Prostate Health
Prostate health issues affect millions of men and it is important to offer a
natural, clinically tested, alternative product with a potentially approved
claim for urologic symptoms of BPH. With multiple published clinical trials,
ProstaGorx® ingredients have been shown to:
1. Work with the prescription drug finasteride to reduce actual prostate weight;
2. Regulate DHT production and hormones that influence prostate volume;
3. Clinically reduce nocturia, and improve prostate symptoms in men with BPH or
prostatitis;
4. Clinically reduce overall rate of progression of prostate cancer in men; and
5. Decrease serum PSA levels, suppression of tumor growth and support urinary
function.
An estimated 50% of men have histologic evidence of BPH by age 50 and 75% by age
80; in 40–50% of these men, BPH becomes clinically significant] BPH was one of
the ten most common, and costly, diseases in men older than 50 years of age in a
recent study in the United States.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is 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. 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.fluticare.com; www.beyondhumantestosterone.com;
www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.com;
www.allervarx.com; www.apaez.com; and www.prostagorx.com.
About Lavasta Pharma
Lavasta Pharma is a multi-specialty health care company focused on representing
and commercializing innovative pharmaceuticals and over-the-counter consumer
products that enable people to live life to its greatest potential. The
company’s services currently extend to cover the region of Africa, Middle East
and Turkey.
Lavasta Pharma has a regional team that manages the strategic execution of
commercial operations across the AFMET region with a sales force team on the
ground of 150+ across the region.
Lavasta Pharma has 2 main affiliated companies: (a) Lavasta Pharma FZ-LLC in
Dubai, UAE that serves as the main commercial hub for the AFMET Region and (b)
Lavasta Pharma LLC- UK in London, UK that serves as the Marketing Authorization
and Intellectual Property holding entity.
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, receiving patent protection for any of its
products, to successfully commercialize ProstaGorx® and others in certain Middle
Eastern and North African countries and elsewhere and to achieve its other
development, 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 annual report on Form 10-K, and other filings made with
the SEC. Copies of these reports are available from the SEC's website or without
charge from the Company.
# # #
Contact:
James S. Painter III
Emerging Markets Consulting, LLC
Tel: 407 340 0226
jamespainter@emergingmarketsllc.com
Source: Innovus Pharmaceuticals, Inc.
Innovus Pharma Announces
Official Launch of its Amazon®, Walmart®, eBay® and Wish® On-Line Stores with a
Combined 116 Product SKUs
SAN DIEGO--January 18, 2018 -- Innovus Pharmaceuticals, Inc. (OTCQB:
INNV) ("Innovus
Pharma" or the “Company”), 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 the official launch of its Amazon®, Walmart®, eBay®
and Wish® on-line stores in the United States with a combined 116 Company
product SKUs. As part of this on-line product distribution, the Company also
secured worldwide non-exclusive rights to sell two primary products from
Antiaging Systems, Ltd.: Can-C™ and Melatonin (MZS™).
The launch of the U.S. on-line stores adds to Innovus Pharma’s substantial
on-line sales presence and expands its other
on-line websites and its Beyond Human® platform, which currently include over
160 websites and over 2.5 million subscribers.
“We are very excited to announce the official launch of our Amazon®, Walmart®,
eBay® and Wish® on-line stores with our current combined 116 product SKUs,” said
Innovus CEO Dr. Bassam Damaj. “We are already seeing a significant increase in
our month over month sales from the on-line stores and we currently expect the
on-line sales to be a growing percentage of our revenues in the very near
future.
“In addition, we are working on the development and launch of additional Amazon®
sites in Canada, Mexico and the United Kingdom and we look forward to growing
our on-line presence of our products and additional products such as Can-C™ and
Melatonin (MZS™) that already have large on-line sales presences with Can-C™
alone generating on average across all sellers on Amazon® around $1.2 million
per year in 2017. These additional sales channels should only serve to increase
the overall sales revenues we may see in the future through our ever-growing
online channels,” he continued.
About Can-C™ Eye Drops
Can-C™ eye drops, made by Antiaging Systems, Ltd., are the original N-acetylcarnosine
(often shorted to “NAC”) eye drop formula developed to normalize senile cataract
impairment.
Users and scientists have reported that Can-C™ is also great for:
Dry eye syndrome.
Benefit for those who wear contact lenses, particularly soft contact lenses.
(Not only do the lubricants in Can-C™ help contact lenses feel more comfortable,
but N-acetylcarnosine is also believed to inhibit the buildup of lactic acid in
the eye, meaning you can wear them in comfort for longer.)
- Corneal disorders.
- Computer vision syndrome.
- Eye strain.
- Ocular inflammation.
- Blurred vision.
- Presbyopia.
- Retinal diseases.
- Vitreous opacities and lesions.
- Complications of diabetes mellitus and other systemic diseases.
- Open-angle primary glaucoma.
Cataract surgery is the most commonly performed operation in the world with over
1.5 million operations in the United States alone every year. Although generally
safe, there is still a complication rate of 30% to 50% of patients who develop
opacification of the posterior lens capsule within two years and require further
laser treatment. Can-C™ cataract eye drops have helped thousands of people
normalize their cataracts without surgery, leaving the natural lens in place
rather than an artificial one.
Human trials on people suffering from senile cataract, using a twice daily dose
of Can-C™ for six months showed the following results:
88.9 percent of patients had improved glare sensitivity;
90 percent reported improved visual acuity – clearer and sharper vision; and
Perhaps most significantly, 41 percent of patients experienced a significant
improvement in lens ‘transmissivity.’
And while the patients were taking the NAC carnosine eye drops, the lead
researcher noted that there was no recurrence of cataract.
About Melatonin (MZS™)
Melatonin (MZS™) is made by Antiaging Systems Ltd. and its main ingredient,
melatonin, is vital to protect a person’s hormonal system, regulate immunity and
repair the body’s cells.
It is commonly used by shift workers and also to treat jet lag and age-related
sleep disorders, but its abilities go far beyond simply its sleep-inducing
properties. Other benefits of the product are its use as an antioxidant, for
longevity and for age related macular degenerations.
Melatonin’s effect on longevity is well documented; in fact laboratory tests on
rats and mice have demonstrated that melatonin increased their lifespans by 20%.
Numerous experts believe melatonin is a vital anti-aging product because of its
positive effect on the aging immune system, its protection of the cardiovascular
system, its ability to increase growth hormone production and above all its
capacity to limit free radical damage.
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.
Amazon® is a registered trademark of Amazon.com, Inc. (NASDAQ: AMNZ); eBay® is a
registered trademark of eBay, Inc. (NASDAQ: EBAY); Walmart® is a registered
trademark of Wal-mart Stores, Inc. (NYSE: WMY); and Wish® is a registered
trademark of ContextLogic, Inc.
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 sales of its products
through its Amazon® stores and through its other on-line channels, 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.
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226
jamespainter@emergingmarketsllc.com
Source: Innovus Pharmaceuticals, Inc.
Innovus Pharma Hemorrhoid Drug
Xyralid™ Receives Approval in Canada
Xyralid™, a Lidocaine-based Cream for the Relief of Pain and Symptoms Caused by
Hemorrhoids, is the Sixth Innovus Pharma Product approved in Canada to Date
SAN DIEGO--January 16, 2018 -- Innovus Pharmaceuticals, Inc. (OTCQB:
INNV) ("Innovus
Pharma" or the “Company”), an emerging commercial-stage pharmaceutical company
that delivers safe, innovative and effective over-the-counter medicine and
consumer care products to improve men’s and women's health and respiratory
diseases, today announced the approval of its Product License Application (“PLA”)
in Canada for its lidocaine-based cream Xyralid™ (DIN 02471434), for the relief
of pain and symptoms caused by hemorrhoids. Xyralid™ will be available as an
over-the-counter (“OTC”) or behind the counter drug and will not require a
prescription.
“We are very happy that Health Canada has approved our Xyralid™ drug in Canada,”
said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus
Pharma. “Xyralid™ is our sixth product on the Canadian market including Zestra®,
Zestra Glide® and Uxor™ (EjectDelay™) marketed by Orimed Pharma, UriVarx®
through our recently announced partnership with Acerus Pharmaceuticals
Corporation and Vesele® through our own marketing and sales efforts in that
country. Innovus is expected to launch the product in Canada by the second half
of 2018.”
About Xyralid™
Xyralid™ is an FDA-OTC monograph compliant, fast-acting and powerful hemorrhoid
anesthetic cream. It contains the active ingredient drug, lidocaine, which
provides fast relief for the pain and symptoms caused by hemorrhoids.
Hemorrhoids, also called “piles”, are swollen and inflamed veins in the anus and
lower rectum. Hemorrhoids may result from straining during bowel movements or
from the increased pressure on these veins during pregnancy, among other causes.
Hemorrhoids may be located inside the rectum (internal hemorrhoids) or they may
develop under the skin around the anus (external hemorrhoids). There are over
1.2 million hemorrhoid sufferers in Canada making it a very large market1.
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.
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 Xyralid™ drug 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.
Emerging Markets Consulting, LLC
James S. Painter III
Tel: +1 407 340 0226
jamespainter@emergingmarketsllc.com
Source: Innovus Pharmaceuticals, Inc.o
Innovus Pharma Announces U.S. Food and Drug Administration Clearance of Its
UriVarx® Urinary Tract Infection Test Strips
Company Expects Sales of Its UriVarx®
Franchise to Increase With Addition of UTI Test Strips
SAN DIEGO--January 11, 2018 -- Innovus Pharmaceuticals, Inc. (OTCQB:
INNV) ("Innovus
Pharma" or the “Company”), an emerging commercial-stage pharmaceutical company
that delivers safe, innovative and effective over-the-counter medicine and
consumer care products to improve men’s and women's health and respiratory
diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has
cleared its UriVarx® Urinary Tract Infection (“UTI”) test strips under the
510(k) filing of its manufacturing partner, ACON Laboratories, Inc. (“ACON”).
Innovus Pharma will offer the recently cleared UriVarx® UTI test strips, which
provide results in 2-minutes, to its customers who buy its UriVarx® product. The
UTI test strips are complementary to the Company’s UriVarx® supplement currently
on the market and clinically tested in patients with overactive bladder (“OAB”)
and urinary incontinence (“UI”). The UTI test strips will also be offered
separatel y
by Innovus Pharma and are manufactured by ACON. Innovus Pharma currently is
expected to launch the UTI strips in Q1 2018.
According to WebMD, UTIs are the most common bacterial infections in the United
States. According to a study by the National Institutes of Health in 2007 (NIH
publication 075512) by Griebling et al., the prevalence of UTI is found to be
higher in women. Nearly 20% of UTIs are found in men. Patients with OAB and UI
have a higher occurrence of UTI infections and early detection is key in better
responses to treatments.
“We are very pleased that ACON has secured the FDA clearance of the UriVarx® UTI
test strips,” stated Dr. Bassam Damaj, President and Chief Executive Officer of
Innovus Pharma. “We look forward to launching the UriVarx® strips with our
UriVarx® clinical supplement for bladder health to enable our customers to be
able to use our FDA cleared UTI test strips to monitor ongoing bladder
infections from the convenience of their homes. We expect the addition of the
UTI strips to increase our clinical supplement sales and the average life cycle
of our monthly product subscriptions,” he continued.
The Company recently announced the approval of UriVarx® by Health Canada and the
signing of a commercial license agreement with Acerus Pharmaceuticals
Corporation in Canada for the product.
About UriVarx® Clinical Supplement
UriVarx® is clinically published to reduce urinary urgency, accidents and both
day and night frequency in OAB and UI patients.
UriVarx® has undergone two double blind and comparative trials in both male and
female OAB and UI patients. The clinical results include:
Reduction of ~56% in Urge Incontinence;
Reduction of ~66% in Stress Incontinence;
Reduction of ~61% in Urinary Urgency;
Reduction of ~33% in Urinary Frequency meaning the total average urinary
frequency was in the normal/ideal range after two months of use; and
Reduction of ~46% in Nocturia.
According to the U.S. National Association for Continence (“NAFC”), OAB is a
medical term that describes various symptoms caused by involuntary bladder
spasms, including urinary frequency, especially at night, and urgency with or
without involuntary leakage. These symptoms may occur without obvious cause or
be secondary to certain diseases of the nervous system. The NAFC estimates that
nearly 25 million Americans suffer from some form of OAB or incontinence. The
condition, with frequency and urgency only, affects men and women of all ages,
although most are under age 65.
About the UriVarx® FDA Cleared UTI Test
The UriVarx® UTI test strips are FDA-cleared tests for the detection of
leukocytes and nitrites to add in the screening of Urinary Tract Infection for
self-testing. The test has undergone clinical trials and the results can be seen
in two minutes.
According to a study by Grand View Research (April 2016), the market size for
urinalysis tests in 2015 worldwide was $1.37 billion and in North America was
$510 million of which UTI testing represented a large percentage of that market.
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 be
a leader in developing and marketing new OTC and branded Abbreviated New Drug
Application (“ANDA”) products, men’s and women’s health supplements, related
diagnostics and medical devices. The Company is actively pursuing opportunities
where existing prescription drugs have recently, or are expected to, change from
prescription (or Rx) to OTC, as well as related products.
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 ACON Laboratories, Inc.
ACON Laboratories Inc. is a privately-owned diagnostics and medical device
company, which was founded in 1995, with its headquarters located in San Diego,
California. ACON Laboratories, Inc. produces a broad range of medical diagnostic
and healthcare products that are sold in over 130 countries worldwide. The
company continues to expand its product lines through extensive research and
development, with the goal of helping improve the health and well-being of
patients around the world. ACON’s manufacturing facility is a US FDA registered
manufacturer of rapid diagnostic and healthcare products.
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 and
the accompanying UTI test strips in the United States 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.
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226
jamespainter@emergingmarketsllc.com
Source: Innovus Pharmaceuticals, Inc.
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--January 8, 2018 -- Innovus Pharmaceuticals, Inc. (OTCQB:
INNV) ("Innovus
Pharma" or the “Company”), 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:
Reduction of ~56% in Urge Incontinence;
Reduction of ~66% in Stress Incontinence;
Reduction of ~61% in Urinary Urgency;
Reduction of ~33% in Urinary Frequency meaning the total average urinary
frequency was in the normal/ideal range after two months of use; and
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
Emerging Markets Consulting, LLC
James S. Painter III
407 340 0226
jamespainter@emergingmarketsllc.com
Source: Innovus Pharmaceuticals, Inc.
-------------------------------------------------------------------
About Innovus Pharmaceuticals, Inc.:
About Innovus Pharma
Headquartered in San Diego, Innovus Pharma is 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. 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.
Our Mission Statement
Innovus Pharma's mission is to in-license, acquire or develop over-the-counter
and consumer healthcare products designed for in-home treatment of medical
conditions and ailments to help people take care of themselves and their
families in order to live healthy lives.
Management Team
Bassam Damaj, Ph.D.
President and Chief Executive Officer
Dr. Bassam Damaj was appointed to serve as our President and Chief Executive
Officer in January 2013. Prior to joining Innovus Pharma, Dr. Damaj served as
President and Chief Executive Officer of Apricus Biosciences, Inc. (NASDAQ: APRI),
a specialty pharmaceutical company, from December 2009 until November 2012. At
Apricus Bio, Dr. Damaj was responsible for the approval of its lead drug Vitaros,
a treatment for erectile dysfunction. Dr. Damaj also signed multimillion dollar
partnerships between Apricus Bio and leading pharmaceutical companies such as
Abbott, Novartis-Sandoz and Takeda. Before Apricus Bio, Dr. Damaj was a
co-founder of Bio-Quant, Inc. and served as the Chief Executive Officer and
Chief Scientific Officer and a Director of Bio-Quant's board of directors from
its inception in June 2000 until its acquisition by Apricus Biosciences in
December 2009. In addition, Dr. Damaj was the founder, Chairman, President and
Chief Executive Officer of R&D Healthcare, and the co-founder of Celltek
Biotechnologies. He also served as a Director of the Board of
Directors
at CreAgri, Inc. and was a Member of the Scientific Advisory Board of MicroIslet,
Inc. He is the author of the Immunological Reagents and Solutions reference
book, the inventor of many patents and author of numerous peer reviewed
scientific publications. Dr. Damaj won a US Congressional award for the Anthrax
Multiplex Diagnostic Test in 2003. Dr. Damaj holds a Ph.D. degree in
Immunology/Microbiology from Laval University and completed a postdoctoral
fellowship in molecular oncology from McGill University.
Randy Berholtz, MBA/JD
Executive Vice President, Corporate Development and General Counsel
Mr. Randy Berholtz is our Executive Vice President, Corporate Development and
General Counsel. He is also the Secretary of the Company. He was the founding
partner of the Sorrento Valley Law Group and is the former Executive Vice
President, General Counsel and Secretary of Apricus Biosciences, Inc. (NASDAQ:
APRI), a specialty pharmaceutical company. Prior to that time, he was the Vice
President, General Counsel and Secretary of ACON Laboratories, Inc., a group of
Chinese and US life sciences companies. He has also been the Chief Operating
Officer and General Counsel of IngleWood Ventures, L.P., a life sciences venture
capital company and the Interim General Counsel and Secretary of Nanogen, Inc.
(NASDAQ: NGEN), a genomics tools company. He has also been an attorney with the
law firms of Heller Ehrman, LLP, Cooley Godward, LLP, Kirkpatrick & Lockhart,
LLP (now K&L Gates) and Cravath, Swaine & Moore. He has a Bachelor of Arts
degree from Cornell University, a Master of Arts degree from Oxford University,
where he was a Rhodes Scholar, and a Juris Doctor degree from Yale Law School
where he was a Senior Editor of The Yale Law Journal and an MBA from the
University of San Diego School of Business.
Rauly Gutierrez, CPA
Vice President of Finance
Mr. Gutierrez was appointed as our Vice President of Finance on September 23,
2016, and was appointed our Principal Financial and Accounting Officer effective
April 24, 2017. He was recently an Audit Senior Manager at KMJ Corbin & Company
LLP, a regional public accounting firm. Mr. Gutierrez began his career at KMJ
Corbin & Company in 2006 and mainly serviced clients in the pharmaceutical and
life science industries which included multiple publicly-traded companies with
market caps ranging from $50 million to $2 billion and revenues ranging from
pre-revenue to $125 million. He has a wide range of experience dealing with SEC
1933 and 1934 Act filings, including IPOs, reverse mergers, SEC comment letters,
Sarbanes-Oxley Act attestation services and periodic SEC reporting requirements.
His areas of expertise include complex debt and equity transactions, such as
derivatives, convertible instruments, and stock-based compensation. He also has
expertise in accounting for gross-to-net revenue recognition for pharmaceutical
product sales, pharmacy drug billings and in business combination transactions.
Mr. Gutierrez has led several training sessions for audit professionals in
professional ethics and independence, PCAOB auditing standards and technical
accounting updates. Mr. Gutierrez received his Bachelor of Science Degree in
Accounting from the Leventhal School of Accounting at the University of Southern
California, and is licensed as a CPA in the State of California. He is also a
member of the AICPA, CalCPA and the Association for Corporate Growth.
Robert C. Verfurth
Vice President of Sales and Marketing
Mr. Robert Verfurth came back to Innovus Pharma as our Vice President of Sales
and Marketing in June 2017. He spent the previous two years building a
commercial team and launching a new blood-based colon cancer technology at
Applied Proteomics, Inc. He was also part of the Innovus Pharma team back in
2013 in a similar role. Mr. Verfurth was also part of the marketing and sales
team at Apricus Biosciences (NASDAQ: APRI), a specialty pharmaceutical company.
Prior to Apricus, Mr. Verfurth was Vice President, US Sales-West for Becton
Dickinson Diagnostics. Before that, he served as Vice President, US Sales and
Support for the molecular diagnostic start-up GeneOhm Sciences beginning in
2005. GeneOhm Sciences was purchased by Becton Dickinson, after which Mr.
Verfurth continued his sales leadership responsibilities in the molecular and
infectious disease product areas. Prior to GeneOhm, Mr. Verfurth held a number
of commercial roles, including Vice President of Sales at both Prometheus
Laboratories and Dianon Systems. He also spent six years in the USAF, achieving
a rank of Captain. Mr. Verfurth earned a Bachelor of Science degree in Business
Administration from the University of Notre Dame and a Master's of Science
degree in Systems Management from the University of Southern California
Innovus Pharma is a leader in OTC and Clinically Proven Consumer Care Products
for Men's and Women's Health, Sexual & Reproductive Health, Vitality and
Respiratory Disease.
SOURCE: http://licoenergymetals.com/
Disclaimer
FN Media Group LLC (FNMG) owns and operates
FinancialNewsMedia.com (FNM)
which is a third party publisher that disseminates electronic information
through multiple online media channels. FNMG's intended purposes are to deliver
market updates and news alerts issued from private and publicly trading
companies as well as providing coverage and increased awareness for companies
that issue press to the public via online newswires. FNMG and its affiliated
companies are a news dissemination and financial marketing solutions provider
and are NOT a registered broker/dealer/analyst/adviser, holds no investment
licenses and may NOT sell, offer to sell or offer to buy any security. FNMG's
market updates, news alerts and corporate profiles are NOT a solicitation or
recommendation to buy, sell or hold securities. The material in this release is
intended to be strictly informational and is NEVER to be construed or
interpreted as research material. All readers are strongly urged to perform
research and due diligence on their own and consult a licensed financial
professional before considering any level of investing in stocks. The companies
that are discussed in this release may or may not have approved the statements
made in this release. Information in this release is derived from a variety of
sources that may or may not include the referenced company's publicly
disseminated information. The accuracy or completeness of the information is not
warranted and is only as reliable as the sources from which it was obtained.
While this information is believed to be reliable, such reliability cannot be
guaranteed. FNMG disclaims any and all liability as to the completeness or
accuracy of the information contained and any omissions of material fact in this
release. This release may contain technical inaccuracies or typographical
errors. It is strongly recommended that any purchase or sale decision be
discussed with a financial adviser, or a broker-dealer, or a member of any
financial regulatory bodies. Investment in the securities of the companies
discussed in this release is highly speculative and carries a high degree of
risk. FNMG is not liable for any investment decisions by its readers or
subscribers. Investors are cautioned that they may lose all or a portion of
their investment when investing in stocks. This release is not without bias, and
is considered a conflict of interest if compensation has been received by FNMG
for its dissemination. To comply with Section 17(b) of the Securities Act of
1933, FNMG shall always disclose any compensation it has received, or expects to
receive in the future, for the dissemination of the information found herein on
behalf of one or more of the companies mentioned in this release. For current
services performed FNMG has been compensated twenty three hundred dollars for
Innovus Pharmaceuticals, Inc. coverage by
a non-affiliated third party. FNMG HOLDS NO SHARES OF Innovus
Pharmaceuticals, Inc.
This release contains "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E the Securities
Exchange Act of 1934, as amended and such forward-looking statements are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. "Forward-looking statements" describe future expectations,
plans, results, or strategies and are generally preceded by words such as "may",
"future", "plan" or "planned", "will" or "should", "expected," "anticipates",
"draft", "eventually" or "projected". You are cautioned that such statements are
subject to a multitude of risks and uncertainties that could cause future
circumstances, events, or results to differ materially from those projected in
the forward-looking statements, including the risks that actual results may
differ materially from those projected in the forward-looking statements as a
result of various factors, and other risks identified in a company's annual
report on Form 10-K or 10-KSB and other filings made by such company with the
Securities and Exchange Commission. You should consider these factors in
evaluating the forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this release are
made as of the date hereof and FNMG undertakes no obligation to update such
statements.
|