LAVAL, QUEBEC, CANADA – Dec. 11, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic)announced today that its orally-active drug candidate, PBI-4050, has been issued a Promising Innovative Medicine (PIM) designation by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) as add-on treatment to nintedanib in patients with idiopathic pulmonary fibrosis (IPF).
“We are proud to have received a second PIM designation in the UK for PBI-4050, following the designation previously received for Alström syndrome,” said Pierre Laurin, President and Chief Executive Officer of Prometic. “We believe PBI-4050 has the capabilities to address various unmet medical conditions such as IPF and Alström syndrome, for which there are severe limitations with the existing standards of care. We look forward to continuing to collaborate with the MHRA with the goal of advancing both the PBI-4050 IPF and Alström syndrome clinical programs as quickly as possible.”
A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with unmet medical need. The PIM designation is a prerequisite to proceed to the EAMS scientific opinion assessment phase, the second and final step in the EAMS process.
The EAMS provides an opportunity for important drugs to be used in UK clinical practice in parallel with the later stages of the regulatory process. It is anticipated that medicines with a positive EAMS opinion could be made available to patients 12 – 18 months before receiving marketing authorization.
More 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 with IPF die each year, 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 about 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 confirms the anti-fibrotic activity of PBI-4050 in several key organs including the kidneys, the heart, the lungs and the liver. It is also effective in improving glucose control in preclinical models of diabetes. Open label Phase II studies in idiopathic pulmonary fibrosis, Alström syndrome and type 2 diabetes have provided preliminary evidence that the results seen in preclinical models translate into the corresponding human diseases.
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 is active in developing its own novel small molecule therapeutic products targeting unmet medical needs in the field of fibrosis, cancer and autoimmune diseases/inflammation. A number of plasma-derived and small molecule products are under development for orphan drug indications. Prometic also 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. Headquartered in Laval (Canada), Prometic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, 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, 2016, 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.
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