MONTREAL, CANADA and MELBOURNE, AUSTRALIA--(Marketwire -06/04/12)- Paladin Labs Inc. ("Paladin")(PLB.TO) and Immuron Limited ("Immuron") (IMC.AX) today announced that Paladin has filed a Non-Traditional Product Licence Application (PLA) that has been accepted for review by Health Canada for Travelan®, an over-the-counter product for the prevention of travellers' diarrhea.
"We are pleased that Health Canada has accepted to review our application for the Canadian regulatory approval of Travelan", said Mark Beaudet, interim President and Chief Executive Officer of Paladin Labs Inc. "Most OTC products on the market today only treat the symptoms of traveller's diarrhea. We expect that Travelan will benefit Canadians because it helps prevent traveller's diarrhea before it even begins."
Clinical studies have shown that Travelan provides protection against the main cause of traveller's diarrhea in 90% of consumers who use it. According to the Public Health Agency of Canada, travellers' diarrhea is the most common illness that affects travellers, especially those travelling to areas such as Central and South America, Mexico, Africa, the Middle East and Asia. Travelan is currently approved in Australia, New Zealand and South Africa.
Paladin obtained the exclusive rights to market and sell Travelan in Canada, Latin America and Sub-Saharan Africa from Immuron in November 2011.
"This is another important milestone for Travelan and Immuron. We look forward to working with Health Canada and Paladin during the review of the application," said Immuron CEO Joe Baini.
Travelan is a natural product which is specifically designed to reduce the risk of infection by ETEC, the most common cause of Travellers' Diarrhea. In clinical trials, Travelan showed protection of up to 90% efficacy against infection with the type of E.coli that causes Travellers' Diarrhea. In addition, trials showed a significant reduction in abdominal cramps and stomach pain compared to those who did not receive Travelan. There were no reported treatment-related side effects in the clinical trials.
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 select international markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into a leading specialty pharmaceutical company. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company's web site at www.paladinlabs.com.
About Immuron Limited
Immuron is a biopharmaceutical company focused on oral immunotherapy treatments using dairy-derived antibody products for humans. Immuron is uniquely positioned with a versatile technology platform capable of generating a wide range of products with a high safety profile. This high safety profile makes it possible to complete pre-clinical studies relatively quickly and increases the prospect that the clinical development of Immuron's products will be expedited. Immuron's current products and product candidates target infectious diseases of the gastrointestinal tract, chronic diseases such as fatty liver (NASH), and the prevention of influenza. Immuron has one product in the market, Travelan, for preventing travellers' diarrhoea. Immuron's main scientific alliances are with Hadassah Medical Center (Israel), the University of Melbourne and Monash University (Australia).
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. The Company 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 the Company 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 the Company's Annual Information Form for the year ended December 31, 2011. The Company 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 the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.