BUSINESS corner Health Canada authorizes Adynovate for Hemophilia A patients under 12 years old On November 21, 2018 Health Canada authorized the use of ADYNOVATE®, an antihemophilic factor (recombinant), PEGylated for the treatment of hemophilia A in children under 12, announced Shire Pharma Canada ULC (Shire Canada), a leading global biotech company focused on rare diseases. The drug was previously approved in November 2016 for use in patients 12 and older. Eric Tse, General Manager of Shire Canada said, “As a leader in developing innovative therapies to improve care for hemophilia patients, Shire is pleased to now offer a treatment option that can help Canadians manage hemophilia A from early childhood through to adulthood”. Hemophilia A affects one in 10,000 people and 25 to 30 per cent of people with severe hemophilia will develop inhibitors, a rare but serious response to treatment with clotting factor concentrates. ADYNOVATE® is the first extended half-life PEGylated (recombinant) factor VIII treatment for perioperative management, the control and prevention of bleeding and the prevention or reduction of frequency of bleeding episodes. “ADYNOVATE®’s unique PEGylation technology allows patients to achieve their treatment goals by providing bleed protection
and extending time between treatments, allowing patients to spend more time leading active lives, doing what they love,” said Tse. Health Canada’s approval was based on the results of a multi-centre, open-label, prospective, uncontrolled Phase 3 clinical study of patients under 12. Of the 66 subjects receiving ADYNOVATE®, 73 per cent
experienced no joint bleeding, 67 per cent had no spontaneous bleeding, and 38 per cent had no bleeding at all during the study. Paul Wilton, President of the Canadian Hemophilia Society expressed the society’s enthusiasm. “It is an exciting time in hemophilia care, with many promising products in the pipeline and coming to market.”
Ipsen Canada Appoints Ed Dybka as General Manager
Ed Dybka
Ed Dybka took over as General Manager for Ipsen Biopharmaceuticals Canada Inc. effective Oct. 15, 2018. “I am honored to be joining Ipsen Canada at such a transformational time in the company’s history and look forward to working on achieving its mission of improving patients’ lives. Throughout my career, I have taken great pride in knowing that the work our industry does directly improves the lives of millions of patients across Canada,” said Dybka. With over 30 years of involvement in the Canadian pharmaceutical industry, Dybka’s most recent experience includes leading the development of an early stage biotech company, a joint venture between MaRS Innovation and The Centre for Drug Research and Development. Prior to this, Dybka served as President and CEO of AstraZeneca Canada Inc. and led the biopharmaceutical start-up Almirall in getting established in Canada. Ipsen North America CEO Richard Paulson expressed his enthusiasm for Dybka’s appointment. “We are delighted to wel-
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come Ed to Ipsen Canada as we establish new milestones on our path to maintaining strong growth and further expanding our relationships with researchers and organizations across the Canadian healthcare ecosystem. Ed brings a wealth of leadership expertise, a track record of fostering innovation, and an in-depth understanding of our industry garnered from his extensive work within the Canadian pharmaceutical market. He is a valuable addition to the Ipsen Canada team.” Paulson also thanked outgoing General Manager Paul Reider who left Ipsen to pursue other opportunities. “Paul has been an instrumental team member and I’d like to thank him for his many contributions and unwavering commitment to the business over the last few years. I wish him well in his new endeavors.” Headquartered in Mississauga, Ont., Ipsen Biopharmaceuticals Canada Inc. is the Canadian affiliate of Ipsen, focusing on innovation and specialty care.
