Paladin and Takeda Sign Licensing and Distribution Agreement for Fomepizole in Japan

Tue May 10, 2011 8:04am EDT

* Reuters is not responsible for the content in this press release.

WIRE) -- 
Paladin Labs Inc. (TSX: PLB)("Paladin") and Takeda Pharmaceutical Company
Limited (TSE: 4502)("Takeda") announced today that they have entered into
a licensing and distribution agreement under which Paladin has granted
Takeda an exclusive right to develop and commercialize fomepizole
(marketed and distributed by Paladin under the trademark Antizol(R) in
Canada and the United States) for the treatment of ethylene glycol and
methanol poisonings in Japan. Under the terms of the agreement, Paladin
will receive from Takeda an undisclosed upfront payment for the product
together with royalty payments based on fomepizole sales in Japan.
Further financial terms of the agreement were not disclosed.

    The ingestion of ethylene glycol or methanol is a medical emergency
characterized by central nervous system depression, severe metabolic
acidosis, renal failure and coma. Untreated ingestions can be lethal if
left untreated or undiagnosed. In Japan, the annual prevalence of
ethylene glycol and methanol poisonings is reported in excess of
approximately two dozen cases. 

    Takeda will be solely responsible for the development and
commercialization of fomepizole in Japan as part of the Ministry of
Health, Labour and Welfare's initiative "Unapproved New Drugs and New
Indications with High Medical Needs"(i) held on April 27, 2010 to help
promote the development of unapproved medications and treatments for
indications that are not approved in Japan despite their being approved
in Europe and the United States. 

    "Antizol(R) serves a critical care need in the treatment of ethylene
glycol and methanol poisoning," said Jonathan Ross Goodman, President and
CEO of Paladin. "This product has proven its value in the marketplace in
both Canada and the United States and is a truly innovative product. We
believe that Antizol(R) will fulfill a need not currently being met
within the emergency treatment landscape in Japan."

    "It is significant for a pharmaceutical company to make effective
treatments commonly used outside Japan available for Japanese patients as
early as possible," said Yasuchika Hasegawa, President and CEO of Takeda.
"We will accelerate development of this drug, and will continue
initiatives to reduce concerns of unapproved new drugs and new
indications in Japan."

    (i)This initiative started under the auspices of the Ministry of Health,
Labour and Welfare for the purpose of "helping promote the development of
unapproved medications and treatments for unapproved indications by
pharmaceutical companies, by means of assessing medical needs for
pharmaceutical products or indications that are not approved in Japan
despite their use being approved in Europe and the United States, and
evaluating whether they are eligible for submission based on evidence
already in the public domain, and the necessity of conducting any
additional study in order to file an application."

    About fomepizole

    Fomepizole is an alcohol dehydrogenase inhibitor. By inhibiting alcohol
dehydrogenase, the ethylene glycol- or methanol-metabolizing enzyme, the
drug controls the metabolization of the two substances, thereby
preventing the production of poison-causing toxic metabolites. Based on
its high affinity with alcohol dehydrogenase, fomepizole is used as
standard treatment for ethylene glycol and methanol poisonings. Paladin
commercializes the drug in the U.S. and Canada under the trademark

    About Paladin Labs Inc.

    Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing innovative
pharmaceutical products for the Canadian and world markets. 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, please visit the Company's web site at

    About Takeda Pharmaceutical Company Limited

    Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for patients worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website,

    Forward Looking Statements Related to Paladin

    This press release may contain forward-looking statements and
predictions. These forward-looking statements, by their nature,
necessarily involve risks and uncertainties that could cause actual
results to differ materially from those contemplated by the
forward-looking statements. Paladin Labs Inc. considers the assumptions
on which these forward-looking statements are based to be reasonable at
the time they were prepared, but cautions that these assumptions
regarding the future events, many of which are beyond the control of
Paladin and its subsidiaries, may ultimately prove to be incorrect.
Factors and risks, which could cause actual results to differ materially
from current expectations, are discussed in the annual report as well as
in Paladin's Annual Information Form for the year ended December 31,
2010. Paladin disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information or
future events and except as required by law. For additional information
on risks and uncertainties relating to these forward-looking statements,
investors should consult Paladin's ongoing quarterly fillings, annual
report and Annual Information Form and other fillings found on SEDAR at

    Forward Looking Statements Related to Takeda

    This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook,
strategies, results for the future, and other statements that are not
descriptions of historical facts. Forward-looking statements may be
identified by the use of forward-looking words such as "may," "believe,"
"will," "expect," "project," "estimate," "should," "anticipate," "plan,"
"assume," "continue," "seek," "pro forma," "potential," "target,"
"forecast," "guidance," "outlook" or "intend" or other similar words or
expressions of the negative thereof. Forward-looking statements are based
on estimates and assumptions made by management that are believed to be
reasonable, though they are inherently uncertain and difficult to
predict. Investors are cautioned not to unduly rely on such
forward-looking statements. 

    Forward-looking statements involve risks and uncertainties that could
cause actual results or experience to differ materially from that
expressed or implied by the forward-looking statements. Some of these
risks and uncertainties include, but are not limited to, (1) the economic
circumstances surrounding Takeda's business, including general economic
conditions in Japan, the United States and worldwide; (2) competitive
pressures and developments; (3) applicable laws and regulations; (4) the
success or failure of product development programs; (5) actions of
regulatory authorities and the timing thereof; (6) changes in exchange
rates; (7) claims or concerns regarding the safety or efficacy of
marketed products or product candidates in development; and (8)
integration activities with acquired companies. 

    The forward-looking statements contained in this press release speak only
as of the date of this press release, and Takeda undertakes no obligation
to revise or update any forward-looking statements to reflect new
information, future events or circumstances after the date of the
forward-looking statement. If Takeda does update or correct one or more
of these statements, investors and others should not conclude that Takeda
will make additional updates or corrections.

Paladin Labs Inc.
Samira Sakhia
Chief Financial Officer

Takeda Pharmaceutical Company Limited
Seizo Masuda

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