First and only BTK inhibitor to be granted provincial formulary approval

TORONTO, Feb. 6, 2023 /CNW/ – BeiGene Canada, the affiliate of BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235), a global biotechnology company, announced today that the Government of Quebec will publicly fund BRUKINSA® (zanubrutinib), a second generation inhibitor of Bruton’s tyrosine kinase (BTK), for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare blood cancer. As of February 1st, 2023, BRUKINSA will be included on the List of Medications reimbursed under the Régie de l’assurance maladie du Québec (RAMQ).

“We are pleased with the Quebec government’s decision to support adults living with this rare blood disease through the reimbursement of BRUKINSA,” said Peter Brenders, General Manager, BeiGene Canada. “Timely access to innovative medicines like BRUKINSA supports BeiGene’s mission and passion of bringing affordable and accessible therapies to people across the world while creating a lasting impact. As equitable access to BRUKINSA for patients across Canada is a high priority, BeiGene Canada is working with other provinces for the addition of this medication to their respective public drug plans.”

A slow-growing cancer of the lymphatic system, WM is responsible for changes to B-Cells, resulting in the production of abnormal cells which multiply and make an excessive amount of an antibody called IgM, which causes blood to become very thick and impede flow throughout the body.1 This can lead to many of the symptoms associated with WM, including excess bleeding, vision problems, cardiovascular complications and nervous system issues.1

“While treatment for WM continues to advance, not all patients with this cancer respond uniformly, so access to new therapies is critical” said Dr. Rayan Kaedbey, hematologist and stem cell director, Department of Hematology, Jewish General Hospital, McGill University, Montreal, Quebec. “The Quebec reimbursement of BRUKINSA, a second generation BTK inhibitor, will allow Quebec WM patients access to a valuable treatment option.”

WM is very rare.2 In Canada, only 150 people are diagnosed each year and there are approximately 1,500 patients in total.2 It is more common in men than women and usually affects older adults.2 While WM is currently incurable; it is treatable.2 In fact, significant progress has been made in the treatment of WM through research that has dramatically increased the life expectancy of WM patients.2

“There is variation across Canada in how long each jurisdiction takes to add a new cancer drug to its public formulary which makes the addition of BRUKINSA to the RAMQ drug list a very important milestone for Quebecers living with Waldenström’s macroglobulinemia,” says Paul Cadrin, who leads the patient support group in Montreal for the Waldenström’s Macroglobulinemia Foundation of Canada. “We are thrilled that the Quebec government has recognized the urgency surrounding coverage of this medication for this rare disease patient population.”

BRUKINSA received its Notice of Compliance (NOC) from Health Canada on March 2, 2021. In addition to the new RAMQ listing, BRUKINSA is also available through private insurance plans.

About BRUKINSA3

BRUKINSA blocks a specific protein in the body that helps cancer cells live and grow. This protein is called “Bruton’s tyrosine kinase” or BTK. By blocking this protein, BRUKINSA may help kill and reduce the number of cancer cells and slow the spread of the cancer.

For more information, please refer to the product monograph for BRUKINSA located here.

About myBeiGene® Patient Support Program

The myBeiGene® patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA. It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well provide practical and emotional support by connecting them to third-party resources that can address their individual needs. Case managers are available Monday through Friday from 8 a.m. to 5 p.m. Eastern Time at 1-833-234-4366.

About Waldenström’s macroglobulinemia

Waldenström’s macroglobulinemia (WM) is a rare indolent (slow growing) B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin’s lymphoma (NHL).4 The disease is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.4  In North America, only 4 people per 1 million are diagnosed with WM each year.2

About the Waldenström’s Macroglobulinemia Foundation of Canada

The mission of the WMFC (Waldenstrom’s Macroglobulinemia Foundation of Canada) is to support Canadians with WM and their families by offering a range of services that can enhance quality of life for those with WM and ultimately discover a cure. Specifically, a Quebec WMFC support group was launched in 2020 with an aim to provide peer to peer support and offer the opportunity to discuss concerns and share experiences. For more information, please visit: www.wmfc.ca.

About BeiGene Canada

Headquartered in Mississauga, Ontario, BeiGene Canada is the country affiliate of global biotechnology company BeiGene, specialized in the discovery and development of novel, affordable and accessible oncology medications. With a highly experienced and dedicated Canadian leadership team, BeiGene Canada is committed to delivering new cancer therapies to the Canadian oncology community, including patients, caregivers, clinicians, and investigators. For more information about BeiGene Canada, please visit www.beigene.ca.

About BeiGene

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter) and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the inclusion of BRUKINSA on the List of Medications reimbursed under the RAMQ to expand patient access and affordability, the potential for BRUKINSA to be included in other provinces public drug programs, BRUKINSA being a valuable treatment option for patients with WM, and BeiGene’s plans, commitments, aspirations, and goals under the headings “About BeiGene Canada” and “About BeiGene.”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

References

Waldenstrom’s Macroglobulinemia Foundation of Canada. What is WM? Available at: https://www.wmfc.ca/about-wm/what-is-wm/  Accessed January 24, 2023.

Waldenstrom’s Macroglobulinemia Foundation of Canada. Newly Diagnosed.  Available at: https://www.wmfc.ca/about-wm/newly-diagnosed/#:~:text=In%20Canada%2C%20that%20means%20only,1500%20cases%20diagnosed%20each%20year  Accessed January 24, 2023.

BeiGene Canada. BRUKINSA (zanubrutinib) Product Monograph. February 22, 2022. Available at: https://pdf.hres.ca/dpd_pm/00064798.PDF  Accessed January 24, 2023.

Lymphoma Research Foundation. Waldenstrom macroglobulinemia.  Available at: https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/wm/   Accessed January 24, 2023.

For further information: Media Contact: Carol Levine, (514) 703-0256, carol.levine@energipr.com

SHARE THIS: