Paladin Labs Inc.

TSX : PLB


Paladin Labs Inc.

December 02, 2013 17:00 ET

Paladin Announces Filing of New Drug Submission for RLX030 (Serelaxin)

MONTREAL, CANADA--(Marketwired - Dec. 2, 2013) -

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Paladin Labs Inc. (TSX:PLB) today announced that it has filed a New Drug Submission (NDS) that has been accepted for review by Health Canada for RLX030 (serelaxin) for the treatment and symptomatic relief of acute heart failure (AHF).

"We are pleased that Health Canada has accepted to review our submission for Canadian regulatory approval for RLX030," said Mark Beaudet, interim President and Chief Executive Officer of Paladin Labs Inc. "We believe that RLX030 can fill an important unmet medical need in the treatment of AHF patients in Canada. Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians."

Paladin acquired the exclusive right to commercialize RLX030 in Canada through a 1999 license agreement with Corthera, Inc., a company based in San Carlos, California, USA (Corthera). Corthera was acquired by Novartis in 2010 and continues to be part of the Novartis group. Under the license agreement, Paladin is responsible for seeking Health Canada's approval to market RLX030 and is working with Corthera and Novartis, as applicable, to determine key strategies, exchange relevant information, and monitor the progress of the regulatory filing.

About AHF

It is estimated that there are 500,000 Canadians living with heart failure and 50,000 new patients are diagnosed each year1. Every AHF episode contributes to a downward spiral of worsening heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode2. There is an urgent need for new treatments that help relieve patients' symptoms and protect the vital organs against damage during an AHF episode, as well as have the potential to increase life expectancy in the AHF patient population.

About RLX030

RLX030 is the first in a new class of medicines and is believed to act through multiple mechanisms on the heart, kidneys and blood vessels3. Results from the phase III RELAX-AHF clinical trial released in 2012 demonstrated inter alia that RLX030 reduced the risk of death by more than one-third (37%) compared with conventional treatment at six months4. RLX030 is currently the only drug for which a reduction in all-cause mortality has been observed in patients with AHF in a major study4.

Following submissions by Novartis entities, RLX030 is currently also being assessed by health authorities around the world including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of AHF. In June 2013, the FDA granted RLX030 Breakthrough Therapy designation status, recognizing its potential to address a serious unmet medical need5.

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 about Paladin, please visit the Company's web site at www.paladinlabs.com.

1 Ross H, Howlett J, Arnold JMO, Liu P, O'Neill BJ, Brophy JM et al. Treating the right patient at the right time: Access to heart failure care. Canadian Journal of Cardiology 2006;22(9):749-54

2 Mosterd A, Hoes A. Clinical epidemiology of heart failure. Heart 2007;93:1137-1146.

3 Metra M, Cotter G, Davison BA. et al. Effect of Serelaxin on Cardiac, Renal and Hepatic Biomarkers in the RELAX-AHF Development Program: Correlation with Outcome. J Am Coll Cardiol. 2013;61(2):196-206

4 Teerlink et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet 2013;381:29-39.

5 FDA. Frequently Asked Questions: Breakthrough Therapies. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm accessed December 2 2013.

Forward Looking Statements

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, 2012. 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 fillings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.

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