Toronto, Ontario, November 1, 2018 — Verity Pharmaceuticals Inc. is pleased to announce submission of the New Drug Submission (NDS) to Health Canada for review and approval of VERITY-ONCO-BCG (Bacillus Calmette–Guérin) as an antineoplastic agent for bladder cancer instillation. The drug will be marketed in Canada through an exclusive licensing agreement with Serum Institute of India Private Ltd. (SIIPL), a world leader in the development and manufacture of vaccines. Under the terms of the agreement, SIIPL will supply the finished product and Verity will market and distribute to the Canadian market.
AN IMPORTANT TREATMENT FOR BLADDER CANCER PATIENTS
Bacillus Calmette–Guérin (BCG) is the main intravesical immunotherapy for treating nonmuscle-invasive bladder cancer (NMIBC). It is instilled directly into the bladder through a catheter. A weakened form of the tuberculosis mycobacterium, BCG stimulates immune responses within the bladder to destroy the cancer cells.
Once a transurethral removal of bladder tumour (TURBT) procedure is performed, treatment with BCG is started. After initial treatment, follow up instillations are performed periodically over the next 3 years.
ADDRESSING THE NEED FOR A CONSISTENT SUPPLY OF BCG
“Approximately 8,900 Canadians are diagnosed with bladder cancer each year. For high risk patients, BCG is a proven and valuable adjunct to TURBT and the gold standard of care for decreasing the recurrence and progression of NMIBC. However, due to recent shortages of BCG in Canada over the past several years, some bladder cancer patients have been faced with the dilemma of non-existent or rationed BCG therapy, thus compromising their chances of survival. A new and consistent supply of BCG will address this issue head on and should be a welcome relief to urologists, oncologists, and their patients.” – Dr. Neil Fleshner MD, MPH, FRCSC, Chief Medical Officer, Verity Scientific Advisory Board.
Established more than 50 years ago, and located in a state-of-the-art facility in Pune, India, SIIPL is the world’s largest manufacturer of vaccines by number of doses produced; having its reach in over 170 countries. 65% of the children in the world receive at least one vaccine manufactured by SIIPL. Licensed for manufacture of the BCG vaccine in 2001 and prequalified by the World Health Organization (WHO) in 2003, SIIPL has since supplied the BCG vaccine to more than 130 countries. “Our collaboration with SIIPL is off to a great start and their assistance in preparation for our NDS has been superb. We look forward to a long-lasting relationship and to providing a steady and reliable supply of BCG to the Canadian market.” – Howard Glase, CEO, Verity Pharma
ABOUT VERITY PHARMACEUTICALS
Verity Pharma is a specialty pharmaceutical company focused on providing therapeutically relevant legacy agents to the Canadian health care community. VERITY-ONCO-BCG represents one of several important products queued for launch in 2019 and meets our mandate of ensuring that the healthcare community has access to prescription products that have been withdrawn from the market, are in short supply, or have not yet been made available in Canada.