ProMetic Life Sciences Inc.
TSX : PLI
OTCQX : PFSCF

ProMetic Life Sciences Inc.

October 13, 2015 06:30 ET

ProMetic's PBI-4050 Granted Orphan Drug Designation for the Treatment of Idiopathic Pulmonary Fibrosis in Europe

LAVAL, QUEBEC--(Marketwired - Oct. 13, 2015) - ProMetic Life Sciences Inc. (TSX:PLI) (OTCQX:PFSCF), ("ProMetic" or the "Corporation") announced today that an orphan drug designation status has been granted for its lead drug candidate, PBI-4050, for the treatment of idiopathic pulmonary fibrosis ("IPF"), by the European Commission.

ProMetic is currently investigating the safety, tolerability and effects of PBI-4050 on pulmonary function, disease progression and inflammatory/fibrotic biomarkers in a Canadian open-label Phase II study in 40 patients suffering from IPF. ProMetic also expects to file an IND with the FDA during the first quarter of 2016 for a multi-center, double-blind, placebo-controlled pivotal study with IPF patients currently on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo.

Commenting on the European orphan drug designation grant, Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer, said: "This is the second orphan drug designation secured by ProMetic regarding PBI-4050 for the treatment of IPF following the similar grant by the US FDA in February 2015. This grant confirms that there is still an urgent need in Europe for a safe and effective treatment of this devastating disease" .

In gold standard animal models proven to emulate pulmonary fibrosis in humans, PBI-4050 performed favorably compared to recently approved drugs to treat this condition. PBI-4050 significantly reduced the tissue scarring in the lungs observed in non-treated animals, indicating the potential for clinically significant improvement and stabilization of lung function in patients with IPF. Moreover, the combination of PBI-4050 and another approved drug generated a further reduction in fibrotic biomarkers in this model, suggesting that a synergistic clinical benefit may be found.

European Orphan Drug Designation is granted to novel drugs or biologics that treat a rare disease or condition affecting fewer than 250,000 patients in the European Union. The designation provides the drug developer with a ten year period of marketing exclusivity upon marketing approval for the designated indication, as well as reduced fees for regulatory activities, the ability to apply for marketing authorisation centrally in the European Union and protocol assistance, a form of scientific advice specifically for orphan medicines.

About Idiopathic Pulmonary Fibrosis ("IPF")

Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, and ultimately fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung, the "alveoli," gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). IPF is usually associated with a poor prognosis. The term 'idiopathic' is used because the cause of pulmonary fibrosis is still unknown. IPF usually occurs in adult individuals of between 50 and 70 years of age, particularly those with a history of cigarette smoking, and affects men more often than women. IPF affects about 128,100 people in the United States, with about 48,000 new cases diagnosed annually. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.

More on PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates' anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases ("CKD"). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end-stage renal disease or ESRD) leading to the need for hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.

Forward Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2014, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

Contact Information

  • Pierre Laurin
    President and CEO
    ProMetic Life Sciences Inc.
    p.laurin@prometic.com
    +1.450.781.0115

    Frederic Dumais
    Senior Director, Communications and Investor relations
    ProMetic Life Sciences Inc.
    f.dumais@prometic.com
    +1.450.781.0115