Montreal, QC /CNW Telbec/ - Valeo Pharma Inc. (CSE: VPH) ("Valeo" or the "Company"), a Canadian specialty pharmaceutical company, announced today that the New Drug Submission ("NDS") filed for a low molecular weight heparin ("LMWH") biosimilar has been accepted for review by Health Canada.
LMWHs are injectable anticoagulant drugs used primarily to treat and prevent deep vein thrombosis and pulmonary embolism. Total Canadian sales of LMWHs exceeded $200M in 2018. There are currently no LMWH biosimilars approved by Health Canada.
"We are pleased to have cleared this important regulatory milestone with Health Canada bringing the NDS one step closer to a marketing authorization. Our extensive clinical data package favourably positions the NDS to meet Health Canada's current approval criteria for LMWH biosimilars. Assuming a fall 2020 approval, Valeo anticipates launching our LMWH biosimilar in the first quarter of 2021. We expect rapid market share gains and are forecasting annual peak sales to exceed $30M in the 3rd year post launch contributing significantly towards Valeo's growth objectives," said Steve Saviuk, President and CEO. "As a competitively priced first new entrant into the Canadian LMWH market in over 20 years and with provincial regulators increasingly mandating the use of biosimilars, we expect to be able to provide significant savings to the Canadian healthcare system."
About Valeo Pharma
Valeo Pharma is a specialty pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada. With a focus on Neurodegenerative Diseases, Oncology, Women's Health and Hospital Specialty Products, Valeo Pharma has a growing portfolio of innovative products and the full infrastructure to properly manage these products through all stages of commercialization. Headquartered in Kirkland, Quebec, Valeo Pharma has all capabilities internally to register and market health care solutions for Canadian patients. For more information, please visit www.valeopharma.com and follow us on LinkedIn and Twitter.
Forward Looking Statements
This press release contains forward-looking statements about Valeo'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.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
SOURCE: Valeo PharmaCopyright 2019 PR Newswire. All Rights Reserved