LAVAL, QUEBEC, CANADA, – February 17, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX:
(“ProMetic” or the “Corporation”) announced today that an orphan drug designation status has been granted for its orally active anti-fibrotic lead drug candidate, PBI-4050, for the treatment of idiopathic pulmonary fibrosis (“IPF”).
In gold standard animal models proven to emulate pulmonary fibrosis in humans, PBI-4050 performed favorably compared to recently approved drugs to treat such condition. PBI-4050 significantly reduced tissue scarring in the lungs observed in non-treated animals, indicating the potential for clinically significant improvement and stabilization in lung function. Moreover, the combination of PBI-4050 and another approved drug generated unprecedented reduction of fibrotic markers in this model, suggesting that synergistic clinical benefit may be found. Health Canada has recently cleared PBI-4050 to commence clinical
trials in patients suffering from IPF.
“We are pleased to have secured an orphan drug designation for our lead drug candidate for the treatment of this devastating disease. This designation supports our decision to aggressively pursue the development of PBI-4050 in various fibrosis related medical conditions”, stated Mr. Pierre Laurin, President and CEO of ProMetic. “We look forward to demonstrating the same efficacy in patients as we have seen in preclinical models”.
Orphan Drug Designation is granted to drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven year period of U.S. marketing exclusivity upon marketing approval for the designated indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and the waiver of prescription drug user fees.
ProMetic has successfully completed its PBI-4050 Phase I clinical trial in 40 healthy volunteers, in which it was found to be safe and well tolerated, with no serious adverse events. The Corporation has also completed the enrolment of patients with diabetic kidney disease (DKD) in the multi-dose part of the currently ongoing Phase Ib trial and is expected to report results thereon by the end of the first quarter of 2015. Health Canada has also cleared PBI-4050 to commence clinical trials in patients suffering from the metabolic syndrome and resulting Type 2 diabetes.
Transactions on ProMetic’s securities were halted by the Investment Industry Regulatory Organization of Canada (“IIROC”) on Friday February 13, 2015 upon confirmation by the Corporation that this announcement became publicly available prior to ProMetic having been duly notified.
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 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year with IPF, a similar number of deaths to those due to breast cancer. 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. (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, 2013, 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.