MISSISSAUGA, ON and MONTREAL, QC, June 17, 2013 /PRNewswire/ - Nuvo Research
Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to
building a portfolio of products for the topical treatment of pain and
the development of its immune modulating drug candidate WF10, and
Paladin Labs Inc. (TSX: PLB), a leading specialty pharmaceutical
company today announced that they have amended their loan arrangements
(the "Loan") originally agreed to in May 2012. In May of 2012, Nuvo
drew down the first $4.0 million tranche of the Loan which has been
paid down to its current principle balance of $2.0 million.
Under the terms of the amended arrangements, Nuvo is entitled to draw
down a second $4.0 million loan tranche immediately and a third $4.0
million loan tranche upon the occurrence of both the (i) launch of
Pennsaid® 2% in the U.S. by Nuvo's U.S. marketing partner, Mallinckrodt Inc. and
(ii) Pliaglis global annual sales achieving a US$5.0 million run rate.
Certain repayment and default provisions have also been amended. The
new tranches of the Loan, as with the first tranche, will bear interest
at 15% per annum.
Paladin will be issued warrants to acquire 50,000 Nuvo common shares at
130% of the 5-day trailing value weighted average trading price
("VWAP") of Nuvo common shares on the Toronto Stock Exchange. If Nuvo
exercises its option to draw down the third tranche of the Loan,
Paladin will be entitled to be issued warrants to acquire a further
50,000 Nuvo common shares at 130% of the VWAP of Nuvo common shares as
of the date that Nuvo draws down the third tranche. The warrants will
expire 3 years from their date of issue.
Paladin will have the right to license the marketing rights to Nuvo's
immune modulation drug candidate, WF10, for Canada, South America and
Central America (the "Paladin Territories"). The terms of the license
will be the same as commercial terms under any WF10 license from Nuvo
to a third party for another territory adjusting any upfront or
milestone payments for the proportionate share of total pharmaceutical
sales in the Paladin Territories relative to the total pharmaceutical
sales in the territory licensed to the third party. Paladin's right to
license WF10 for Paladin Territories will not apply if Nuvo enters into
a global WF10 licensing transaction.
The transactions are subject to typical conditions including regulatory
approval and are expected to be completed within the next 60 days.
"This loan facility from Paladin provides Nuvo with financial resources
to advance our WF10 allergic rhinitis program and for general corporate
purposes so we can continue to execute on our business plan," said
Stephen Lemieux, Nuvo's Vice-President and Chief Financial Officer. "We
very much appreciate the support of our marketing and financial
partner, Paladin Labs, to help us achieve our goals."
"We are pleased to continue to support Nuvo in the development of WF10
and the expansion their pain franchise which is ably led by Pennsaid,"
said Mark Beaudet, interim President and Chief Executive Officer.
About Pennsaid 2%
Pennsaid 2% is a topical non-steroidal anti-inflammatory drug (NSAID)
containing 2% diclofenac sodium compared to 1.5% for original
Pennsaid. It is more viscous than original Pennsaid, is supplied in a
metered dose pump bottle and was studied in clinical trials using twice
daily dosing compared to four times a day for original Pennsaid.
Pliaglis is a topical local anesthetic cream that uses Nuvo's
proprietary phase-changing technology to form a pliable peel on the
skin when exposed to air. In the U.S., Pliaglis is indicated for use
on intact skin in adults to provide local analgesia for superficial
aesthetic procedures, such as dermal filler injection, pulsed dye laser
therapy, facial laser resurfacing and laser-assisted tattoo removal.
In the E.U. Pliaglis is indicated in adults to produce local dermal
anaesthesia on intact skin prior to dermatological procedures. The
Company has licensed worldwide marketing rights to Pliaglis to Galderma
Pharma S.A. (Galderma), a global pharmaceutical company specialized in
dermatology. Galderma launched the marketing and sale of Pliaglis in
the U.S. in March of 2013 and in the E.U. in April of 2013.
The immune system provides an essential defense to microorganisms,
cancer and substances it sees as foreign and potentially harmful. WF10
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. In conditions such as allergic
rhinitis, the body's immune system inappropriately responds to the
presence of foreign allergens. Research suggests that in some cases,
WF10 may rebalance improperly functioning immune systems. WF10 is an
infusion therapy currently approved only in Thailand under the name
IMMUNOKINE for treatment of postradiation chronic inflammatory disease
and diabetic foot ulcers. WF10 is not yet approved for the treatment
of moderate to severe allergic rhinitis and was used in the reported
study on an investigational basis.
About Nuvo Research Inc.
Nuvo is a publicly traded, Canadian specialty pharmaceutical company,
headquartered in Mississauga, Ontario. The Company is building a
portfolio of products for the treatment of pain through internal
research and development. The Company's product portfolio includes
Pennsaid®, Pliaglis and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is
used to treat the signs and symptoms of osteoarthritis of the knee(s).
Pennsaid is sold in the United States by Mallinckrodt Inc., in Canada
by Paladin Labs Inc. and in several European countries. Pliaglis is a
topical local anesthetic cream which provides topical local analgesia
for superficial dermatological procedures. The Company has licensed
worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a
global pharmaceutical company specialized in dermatology. Galderma
launched the marketing and sale of Pliaglis in the U.S. in March of
2013 and in the E.U. in April of 2013. Synera is a topical patch that
combines lidocaine, tetracaine and heat, approved in the United States
to provide local dermal analgesia for superficial venous access and
superficial dermatological procedures and in Europe, for surface
anaesthesia of normal intact skin. Nuvo currently markets Synera in
the United States and its licensing partner, Eurocept International
B.V., has initiated a pan-European launch of Synera (under the name
Rapydan) in several European countries. The Company is also developing
WF10, for the treatment of immune related diseases.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a leading
specialty pharmaceutical company focused on developing, acquiring or
in-licensing innovative pharmaceutical products for the Canadian
market. With this strategy, a focused national sales team and proven
marketing expertise, Paladin has evolved into one of Canada's leading
specialty pharmaceutical companies. Paladin's shares trade on the
Toronto Stock Exchange under the symbol PLB. For more information
about Paladin, please visit the Paladin Web Site at www.paladinlabs.com.
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, statements
concerning the Company's future objectives, strategies to achieve those
objectives, as well as statements with respect to management's beliefs,
plans, estimates, and intentions, 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 the
need for additional financing, the current economic environment,
dependence on sales and marketing partnerships, competitive
developments, as well as other risk factors included in the Company's
annual information form dated March 27, 2013 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. Certain statements included in this news
release may be considered "financial outlook" for purposes of
applicable securities laws, and such financial outlook may not be
appropriate for purposes other than this news release. 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.