BAVENCIO Receives Reimbursement Recommendation from pCODR and INESSS for the Maintenance Treatment of Patients with Advanced Bladder Cancer

MISSISSAUGA, ON, April 29, 2021 /CNW/ - EMD Serono Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC are pleased to announce that ^PrBAVENCIO^® (avelumab for injection) has received recommendations to be reimbursed with clinical criteria and conditions, from the pan-Canadian Oncology Drug Review (pCODR) and by the Institut national d'excellence en santé et en services sociaux (INESSS). BAVENCIO is approved by Health Canada for the maintenance treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma (UC), an advanced type of bladder cancer, whose disease has not progressed following first-line platinum-based chemotherapy.

"BAVENCIO addresses an urgent unmet need for patients with metastatic UC and disease that has not progressed on first line platinum-based chemotherapy," says Dr. Srikala Sridhar, MD MSc FRCPC, Head of the Genitourinary Medical Oncologists of Canada, Associate Professor and Medical Oncologist at the Princess Margaret Cancer Centre. "The reimbursement recommendations by pCODR and INESSS are an important step in getting this treatment to these patients in Canada who need it the most."

"Urothelial carcinoma patients who are diagnosed at the metastatic stage face a five-year survival rate of five per cent; what they need urgently is access to treatment options with as few challenges as possible," says Ferg Devins, a survivor of non muscle invasive bladder cancer and Volunteer Board Chair of Bladder Cancer Canada. "The recommendations are welcomed by patients and their loved ones as a way to help manage the outcomes of this difficult disease."

"Following the Health Canada approval in 2020, we are excited by the pCODR and INESSS milestone recommendations on BAVENCIO," says Manuel Zafra, Managing Director of EMD Serono. "We are proud of what this partnership between EMD Serono and Pfizer Canada can achieve for Canadian UC patients."

"The recommendation by pCODR and INESSS helps to drive our Alliance's continued commitment to patients," says Cynthia Di Lullo, Oncology Lead, Pfizer Canada ULC. "We look forward to working with participating jurisdictions across Canada to increase access to BAVENCIO for the treatment of metastatic UC."

The recommendations in full can be accessed at CADTH.ca and INESSS.qc.ca; BAVENCIO is currently under consideration for negotiation by the pan-Canadian Pharmaceutical Alliance (pCPA).

About bladder cancer in Canada
Bladder cancer is the fifth most common cancer in Canada.¹ In 2020, approximately 12,200 individuals were diagnosed and an estimated 2,600 died from bladder cancer.² Bladder cancer has a recurrence rate of 60-70 per cent in patients.³

About BAVENCIO^® (avelumab for injection)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody and is part of a class of immunotherapy drugs called immune checkpoint inhibitors. BAVENCIO was discovered by Merck KGaA, Darmstadt, Germany and is co-developed and co-commercialized by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC.  BAVENCIO is also indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC) and for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.⁴

About EMD Serono, Canada
EMD Serono, Canada, is the Canadian biopharmaceutical business of Merck KGaA, Darmstadt, Germany. EMD Serono, Canada has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono, Canada has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono, Canada has more than 100 employees across Canada with headquarters in Mississauga, Ontario.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck KGaA, Darmstadt, Germany generated sales of € 17.5 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

BAVENCIO^® is a trademark of Merck KGaA, Darmstadt, Germany or its affiliates.
© 2021 EMD Serono and Pfizer Canada ULC. All rights reserved.

For further information:

Karley Ura
Director, Healthcare, NATIONAL Public Relations
416-858-0537
[email protected]

Smita Devane-Bhan
Head of Communications, EMD Serono
905-919-0245
[email protected]

Sophie Morin
Manager, Corporate Affairs, Pfizer Canada
1-866-9PFIZER (1-866-973-4937)
[email protected]

^1 Canadian Cancer Society. Canadian Cancer Statistics 2019. Https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2019-EN.pdf?la=en. Accessed April 2021.
^2 Canadian Cancer Society. Bladder Cancer Statistics. https://www.cancer.ca/en/cancer-information/cancer-type/bladder/statistics/?region=on#:~:text=Incidence%20and%20mortality&text=In%202020%2C%20an%20estimated%3A,1%2C850%20will%20die%20from%20it. Accessed April 2021.
^3 Bladder Cancer Facts. Bladder Cancer Canada. https://bladdercancercanada.org/en/bladder-cancer-facts/. Accessed April 2021.
^4 BAVENCIO Product Monograph. EMD Serono Inc. and Pfizer Canada ULC; 2020. https://www.pfizer.ca/sites/default/files/202101/BAVENCIO_PM_E_235471_13-Jan-2021.pdf. Accessed April 2021.

SOURCE EMD Serono, Canada