Critical Bladder Cancer Drug Now Fully Available After Years of Shortages

Health Canada releases VERITY-BCG^™ bladder cancer treatment for distribution

TORONTO, Sept. 9, 2021 /CNW/ - Verity Pharmaceuticals Inc. is pleased to announce that it has received approval to begin distributing VERITY-BCG^™ (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I). This approval means that hospitals and clinics across Canada will no longer see shortages of this critical drug.

"Our patient community has faced the stress of realizing that there has been a shortage of BCG, which has resulted in a drug rationing approach at many institutions across Canada," said Ferg Devins, Survivor and Volunteer Chair of Bladder Cancer Canada. "This announcement is truly a relief for all of us who have faced uncertainty resulting from this long term shortage. We are delighted that Health Canada has finally approved another supplier of BCG in Canada.  It will greatly improve patient care," added Devins.

Bacillus Calmette-Guérin (BCG) is a proven immunotherapy of choice for bladder cancer. It is used as first-line intravesical therapy following tumor resection of non–muscle-invasive bladder cancer. Several large pharmaceutical manufacturers of BCG announced shortages within the last decade or stopped production altogether, leading to a worldwide scarcity of the treatment. Verity partnered with Serum Institute of India, which manufactures BCG. Serum Institute is the world's largest manufacturer of vaccines. 

"Increasing global usage and demand of BCG has resulted in a limited and erratic supply for decades and Canada has had just one supplier since 2016," said Howard Glase, Chief Executive Officer, Verity Pharma. "With the addition of VERITY-BCG to the Canadian healthcare system, Canada becomes the first country in the western world to solve the BCG shortage crisis. VERITY-BCG is an example of our expertise in supplying life-saving therapeutic options to help fulfill unmet patient needs."

Bladder Cancer Canada states that bladder cancer is the fifth most common cancer in Canada and that almost 12,000 people will be diagnosed with bladder cancer this year alone.

"BCG is a proven and effective adjunct to transurethral resection (TUR) and the gold standard of care," said Dr. Alexandre Zlotta, Department of Surgery, Division of Urology, University of Toronto. "It is used to help keep the cancer from coming back and potentially becoming life-threatening. It is also the best known immuno-oncological agent, used the last three decades. However, in the last years, BCG shortages were leading to rationing and dose reduction of this crucial bladder cancer drug with unfortunate impact on outcomes. Patients had delayed or sometimes even cancelled treatments. With the availability of VERITY-BCG, Canada's multi-year BCG drug shortage will be a thing of the past as Canadian patients will now have full access to this well-established, safe and efficacious therapy. It will also foster further scientific studies and research."

Amit Thatte, Director of Serum Institute Inc, said the facility supplies BCG for bladder cancer instillations to more than 21 countries around the world.

 "As the manufacturer of the product, we are very pleased to partner with Verity Pharma for the approval and supply of Verity BCG to Canada." he said. "Serum Institute is the world's largest vaccine manufacturer by number of doses produced and sold globally and we take great pride in delivering a safe, efficacious, high-quality product to all of our partners. Our world-class research and production facilities are continuously upgraded to ensure compliance with all regulations and have been accredited by the World Health Organization. We are very happy to have our partnership with Verity Pharma and look forward to providing this life-saving therapy to Canada for years to come."

Ajay Bisaria, High Commissioner of India to Canada, welcomed the announcement.

"India is proud to support this effort to resolve the shortage of BCG in Canada," he said. "With more than 60 percent of global vaccine manufacturing capacity, India believes in vaccine internationalism. This collaboration between the Serum Institute of India and Verity Pharma is a clear demonstration of our commitment to global health."

About VERITY-BCG^™

VERITY-BCG^™ is an adjuvant therapy after transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ.  It is only recommended for stage Ta grade 1 papillary tumors, when there is judged to be a high risk (>50%) of tumor recurrence.

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About Verity Pharmaceuticals Inc.

Founded in Canada and owned by Canadians, and with a head office in Mississauga, Ontario, Verity Pharmaceuticals is a specialty pharmaceutical company focused on providing therapeutically relevant agents to the Canadian healthcare community. Our mission is to provide access to prescription products that are in short supply or have not yet been made available in Canada.

Verity Pharmaceuticals works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant deliverable. We are also committed to supporting programs, initiatives and organizations that help improve health, expand research opportunities, and promote education within the Canadian healthcare community.

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