MONTREAL, CANADA and OSAKA, JAPAN--(Marketwire - May 10, 2011) - 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® 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"* 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® 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® 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."
*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."
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 Antizol®.
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 www.paladinlabs.com.
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, www.takeda.com.
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 www.sedar.com.
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.