BRUKINSA Is the First Bruton’s Tyrosine Kinase
(BTK) Inhibitor Recommended by NICE for Routine Use for WM
BRUKINSA Is the Only BTK Inhibitor Considered
Cost Effective in WM
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company that is developing and commercializing
oncology medicines, today announced that England’s health
technology assessment institute, the National Institute for Health
and Care Excellence (NICE), has issued a final appraisal document
(FAD) recommending BRUKINSA (zanubrutinib) for the treatment of
Waldenstr�m’s Macroglobulinemia (WM) in adults who have had at
least one treatment, only if bendamustine plus rituximab is also
suitable.
This decision from NICE marks BRUKINSA as the first and only
treatment for WM to be recommended for routine use in England and
Wales. The NICE Committee acknowledged the high unmet need for an
effective and well tolerated treatment for WM “where current
chemoimmunotherapy options can cause severe adverse reactions and
the need for frequent hospital visits”.i
WM is a rare form of B-cell lymphoma that occurs in less than
two percent of patients with non-Hodgkin lymphomas. There are
around 4,000 people living with WM in the UK. ii
“BRUKINSA is a highly selective BTK inhibitor,” said Dr Shirley
D'Sa, consultant hematologist and clinical lead at the University
College London Hospitals Centre for WM and Associated Disorders.
“NICE’s positive recommendation for zanubrutinib allows eligible
patients in England and Wales to access an important new treatment
option that may offer improved outcomes compared to the current
standard of care.”
In its appraisal, NICE concluded that zanubrutinib could be
considered “a step-change” in managing the disease as clinical
evidence suggests that people with WM may live longer and have a
better quality of life with zanubrutinib compared to standard of
care. The NICE recommendation states that BRUKINSA is considered
cost-effective at a threshold of £20,000-30,000 per
quality-adjusted life year (QALY).i
“I am very pleased that NICE have agreed that BRUKINSA is a
valuable treatment option for eligible WM patients in England and
Wales, enabling those patients to be among the first patients in
Europe to have access to BRUKINSA,” commented Dr. Robert Mulrooney,
BeiGene General Manager, UK and Ireland. “BeiGene’s mission is to
achieve affordable access to our innovative medicines and we look
forward to working with NICE and the National Health Service in the
UK to create further treatment options for UK patients with blood
cancers.”
About Waldenstr�m’s Macroglobulinemia
WM is a rare B-cell lymphoma that occurs in less than two
percent of patients with non-Hodgkin lymphomas.iii The disease
usually affects older adults and is primarily found in bone marrow,
although lymph nodes and the spleen may be involved.iv Typically,
patients present between the ages of 60 and 70 years. For reasons
that are unclear, WM is almost twice as common in men as in women
and is more common in Caucasians than other ethnic groups.v
Waldenstr�m’s macroglobulinemia is a rare cancer seen only in
approximately three to five per million people per year.iv
About BRUKINSA
BRUKINSA (zanubrutinib) is a small molecule inhibitor of
Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists
that is currently being evaluated globally in a broad clinical
program as a monotherapy and in combination with other therapies to
treat various B-cell malignancies. Because new BTK is continuously
synthesized, BRUKINSA was specifically designed to deliver targeted
and sustained inhibition of the BTK protein by optimizing
bioavailability, half-life, and selectivity. With differentiated
pharmacokinetics compared to other licensed BTK inhibitors,
BRUKINSA has been demonstrated to inhibit the proliferation of
malignant B cells within a number of disease relevant tissues.
BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class
clinical candidates internally or with like-minded partners to
develop impactful and affordable medicines for patients across the
globe. We have a growing R&D and medical affairs team of
approximately 3,300 colleagues dedicated to advancing more than 100
clinical trials that have involved more than 16,000 subjects. Our
expansive portfolio is directed predominantly by our internal
colleagues supporting clinical trials in more than 45 countries and
regions. Hematology-oncology and solid tumor targeted therapies and
immuno-oncology are key focus areas for the Company, with both
mono- and combination therapies prioritized in our research and
development. BeiGene currently has three licensed medicines
discovered and developed in our own labs: BTK inhibitor BRUKINSA®
in the U.S., China, the European Union, Great Britain, Canada,
Australia, and additional international markets; and the
non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as
well as the PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody tislelizumab in North
America, Europe, and Japan. Building upon this productive
collaboration, including a biologics license application (BLA)
under U.S. Food and Drug Administration (FDA) review, BeiGene and
Novartis announced an option, collaboration, and license agreement
in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is
in Phase 3 development. Novartis and BeiGene also entered into a
strategic commercial agreement through which BeiGene will promote
five approved Novartis Oncology products across designated regions
of China.
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more 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 8,500 colleagues spans five
continents, with administrative offices in Beijing, China;
Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
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 potential for zanubrutinib to treat patients with WM, the
advancement, reimbursement and commercialization of zanubrutinib,
and BeiGene’s plans, commitments, aspirations and goals under the
headings “BeiGene Oncology” 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
and commercialization of its drug candidates and achieve and
maintain profitability; 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.
i National Institute for Health and Care Excellence. Final
appraisal document – Zanubrutinib for treating Waldenstr�m's
macroglobulinaemia [ID1427]. September 2022 ii The UK
Charity for Waldenstr�m’s Macroglobulinaemia. Available at
https//wmuk.org.uk iii Buske, C, et al. Treatment and outcome
patterns in European patients with Waldenstr�m’s
macroglobulinaemia: a large, observational, retrospective chart
review. The Lancet Haematology 2018; 5: e0299-309. iv Lymphoma
Research Foundation. Getting the Facts: Waldenstr�m
Macroglobulinemia. Accessed March 2022. Available at
https://lymphoma.org/wp-content/uploads/2021/12/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf
v
https://iwmf.com/frequently-asked-questions-waldenstrom-macroglobulinemia/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220919005638/en/
Investor: Kevin Mannix +1 240-410-0129 ir@beigene.com
Media: Maryline Iva + 41 61 685 2090
media@beigene.com
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Sep 2024 to Oct 2024
BeiGene (NASDAQ:BGNE)
Historical Stock Chart
From Oct 2023 to Oct 2024