-- Nuvo to Host Conference Call/Webcast at
8:30 a.m. ET --
MISSISSAUGA,
ON, Oct. 17, 2014 /PRNewswire/
- Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical
company with a diverse portfolio of topical and immunology
products, today announced that it has completed the sale of its
PENNSAID 2% U.S. sales and marketing rights to Horizon Pharma plc
(NASDAQ:HZNP) for a cash payment of US$45
million (CDN$50 million) which
was payable on closing. Effective January 1, 2015, Horizon will assume U.S.
commercialization of PENNSAID 2% from Nuvo's former U.S. marketing
licensee. Nuvo retains all rights to PENNSAID and PENNSAID 2%
outside of the U.S. and will be seeking a marketing partner or
partners for international territories. Nuvo will supply
PENNSAID 2% to Horizon for the U.S. market from its Varennes, Québec manufacturing facility
pursuant to an exclusive long-term manufacturing agreement.
"This sale was made possible by our recent
litigation settlement with our former U.S. marketing licensee that
returned the U.S. PENNSAID and PENNSAID 2% rights to Nuvo," said
John London, Nuvo's President and
Co-CEO. "This transaction, together with the US$10 million litigation settlement payment, have
generated gross proceeds of over CDN$60
million of non-dilutive cash. We will continue to
explore opportunities to maximize the value of our robust product
pipeline including our lead development asset, WF10, which is
currently being studied in a 183 patient Phase 2 refractory
allergic rhinitis clinical study with results expected in Q1
2015."
About PENNSAID 2%
PENNSAID 2% is a
topical product containing 2% diclofenac sodium compared to 1.5%
for original PENNSAID. It is approved in the U.S. for pain of
osteoarthritis (OA) of the knee(s). It is more viscous than
PENNSAID, is supplied in a metered dose pump bottle and has been
approved for twice daily dosing compared to four times a day for
PENNSAID. The new drug application (NDA) for PENNSAID 2% was
approved by the FDA on January 16,
2014 and the drug is protected by 6 U.S. patents that are
listed in the FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations database or "Orange Book".
About PENNSAID
PENNSAID is used to
treat the signs and symptoms of OA of the knee(s). The drug
combines a transdermal carrier (containing dimethyl sulfoxide,
popularly known as DMSO) with 1.5% diclofenac sodium, a
non-steroidal anti-inflammatory drug (NSAID) and delivers the
active drug through the skin directly to the site of inflammation
and pain. Effective January 1,
2015, PENNSAID will no longer be marketed in the U.S.
It is currently marketed in Canada
by Paladin Labs Inc. and marketed under license and/or distribution
agreements in Greece, Italy and the U.K.
About WF10
WF10 is a solution
containing stabilized chlorite ions that focuses on supporting the
immune system by targeting the macrophage, a type of white blood
cell that coordinates much of the immune system, to regulate normal
immune function. WF10 is an infusion therapy currently
approved only in Thailand under
the name IMMUNOKINE for the treatment of post-radiation-therapy
syndrome.
About The Company's Ongoing WF10 Phase 2
Clinical Trial
This 16-week clinical trial is a randomized,
double-blind, placebo-controlled, multi-center study to assess the
efficacy, safety and tolerability of a regimen of five infusions of
either WF10 or its main constituents (sodium chlorite and sodium
chlorate) relative to saline control in allergic rhinitis patients
experiencing persistence or recurrence of symptomatic episodes in
spite of conventional treatment over the previous year. The
trial will measure total nasal symptom score (TNSS) and other
secondary endpoints. The trial is being conducted at 15 sites
in Germany. It is fully enrolled with 183 patients
participating. Top-line results are expected in Q1
2015. The trial is designed to confirm the results of the
Company's 2010 60 patient, randomized, double-blind,
placebo-controlled, single-center Phase 2 clinical study of WF10
for the treatment of allergic rhinitis which achieved statistical
significance (P<0.001) for its primary endpoint (change in TNSS
at week 3).
About Refractory Allergic
Rhinitis
Allergic rhinitis, a highly prevalent condition
characterized by nasal symptoms (runny, blocked, or itchy nose;
chronic sneezing) is triggered by an inappropriate immune response
to one or more allergens such as pollens, house dust mites and pet
dander. Refractory allergic rhinitis patients often suffer
from severe symptoms and do not respond adequately to common forms
of treatment such as antihistamines and nasal
corticosteroids. Most refractory allergic rhinitis patients
suffer from multiple allergies.
About Nuvo Research Inc.
Nuvo (TSX:NRI)
is a specialty pharmaceutical company with a diverse portfolio of
products and technologies. The Company operates two distinct
business units: the Topical Products and Technology (TPT) Group and
the Immunology Group. The TPT Group has four U.S. Food and
Drug Administration (FDA) approved commercial products, a pipeline
of topical and transdermal products focusing on pain and
dermatology and four drug delivery platforms that support the
development of patented formulations that can deliver actives into
or through the skin. The Immunology Group has two commercial
products, a development program for the treatment of allergic
rhinitis and an immune system modulation platform that has the
potential to support treatments for a broad range of immune system
related disorders. For additional company information visit
www.nuvoresearch.com.
Management to Host Conference
Call/Webcast
Management will host a conference call to
discuss the sale of the PENNSAID 2% U.S. rights to Horizon today
(October 17, 2014) at 8:30 a.m. ET. To participate in the
conference call, please dial 1 (888) 231-8191 or (647) 427-7450,
reference number 22766789. Please call in 15 minutes prior to
the call to secure a line. You will be put on hold until the
conference call begins.
A taped replay of the conference call will be
available two hours after the live conference call and will be
accessible until Friday, October 24,
2014 by calling 1 (855) 859-2056 or (416) 849-0833,
reference number 22766789.
A live audio webcast of the conference call will
be available through www.nuvoresearch.com. Please connect at
least 15 minutes prior to the conference call to ensure adequate
time for any software download that may be required to hear the
webcast.
Forward-Looking Statements
Certain
statements in this news release constitute forward-looking
statements within the meaning of applicable securities laws.
Forward-looking statements include, but are not limited to the
Company's anticipated use of proceeds from the Private Placement,
the Company's future share price and the Company's possible
election to accelerate the expiry date of any of the warrants or
the brokers warrants and similar statements concerning anticipated
future events, results, circumstances, performance or expectations
that are not historical facts. Forward-looking statements generally
can be identified by the use of forward-looking terminology such as
"outlook", "objective", "may", "will", "expect", "intend",
"estimate", "anticipate", "believe", "should", "plans" or
"continue", or similar expressions suggesting future outcomes or
events. Such forward-looking statements reflect management's
current beliefs and are based on information currently available to
management. Forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those contemplated by such statements. Factors that could
cause such differences include general business and economic
uncertainties and adverse market conditions as well as other risk
factors included in the Company's Annual Information Form dated
February 20, 2014 under the heading
"Risks Factors" and as described from time to time in the reports
and disclosure documents filed by the Company with Canadian
securities regulatory agencies and commissions. This list is not
exhaustive of the factors that may impact the Company's
forward-looking statements. These and other factors should be
considered carefully and readers should not place undue reliance on
the Company's forward-looking statements. As a result of the
foregoing and other factors, no assurance can be given as to any
such future results, levels of activity or achievements and neither
the Company nor any other person assumes responsibility for the
accuracy and completeness of these forward-looking statements. The
factors underlying current expectations are dynamic and subject to
change. Although the forward-looking information contained in this
news release is based upon what management believes are reasonable
assumptions, there can be no assurance that actual results will be
consistent with these forward-looking statements. All
forward-looking statements in this news release are qualified by
these cautionary statements. The forward-looking statements
contained herein are made as of the date of this news release and
except as required by applicable law, the Company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
SOURCE Nuvo Research Inc.