Concordia Healthcare Corp. (“Concordiaâ€) (TSX:CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, today announced that its subsidiary, Pinnacle Biologics, Inc. (“Pinnacleâ€), a biopharmaceutical research and development company specializing in rare diseases, has signed a collaboration agreement for PHOTOFRIN® (porfimer sodium) with Orphan Canada, a Toronto-based specialty pharmaceutical company that in?licenses therapies for rare disorders and specialty medicines within Canada. Under the agreement, Pinnacle and Orphan Canada will partner to support the continued supply of Photodynamic Therapy (PDT) using PHOTOFRIN in Canada.
PHOTOFRIN is approved in Canada for the treatment of certain forms of gastrointestinal, lung and bladder cancers.
“Orphan Canada will provide a distribution infrastructure for Concordia within Canada,†said Mark Thompson, CEO of Concordia. “This relationship should provide us with operating flexibility and a depth and scale of product development that may increase access to treatments for patients with rare forms of cancer.â€
PHOTOFRIN was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2004 for cholangiocarcinoma (CCA), a rare bile duct cancer. There are approximately 3,000 CCA cases diagnosed in the U.S. annually1 and there is currently no approved therapy for this cancer type.
In January, Concordia received FDA approval to enroll patients with perihilar CCA in a pivotal Phase 3, multicenter clinical trial using PHOTOFRIN. This international trial will enroll patients from the U.S., Switzerland, Germany, South Korea and Canada. The trial will study the efficacy and safety of PDT with PHOTOFRIN for injection as treatment for unresectable advanced perihilar CCA Bismuth type III/IV. Two sites, CHUM-Hopital St-Lux, Quebec and St. Michael’s Hospital, Ontario, have currently been selected to participate with more sites expected to be operational within the next months.
“Orphan Canada’s experience in the rare disease space enables us to deliver multi-dimensional support for our partners like Concordia who are developing orphan products,†said Jason Flowerday, chief commercial officer, Orphan Canada.
About PHOTOFRIN
Photodynamic therapy with PHOTOFRIN® is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN®. The second stage of therapy uses illumination with nonburning laser light 40-50 hours following injection with PHOTOFRIN®. When injected, PHOTOFRIN® is attracted to certain tissues, especially cancer cells. Tumor destruction results from biochemical reactions, not heat. Tumor selectivity occurs through a combination of preferential retention of PHOTOFRIN® by the tumor and selective delivery of light to the tumor site.
PHOTOFRIN® is indicated for the treatment of esophageal cancer, non-small-cell lung cancer and high-grade dysplasia in Barrett’s esophagus in both the U.S. and Canada. PHOTOFRIN® was granted orphan drug designation (ODD) by the FDA in October 2001 for the ablation of High-Grade Dysplasia in Barrett’s Esophagus in patients who are not considered to be candidates for esophagectomy, in November 2004 for cholangiocarcinoma (CCA), a rare cancer in the bile ducts that carry bile from the liver to the small intestine, and in December 2011, as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma.
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Concordia Healthcare Corp.