BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, is aware that Pharmacyclics LLC has filed a complaint against BeiGene, Ltd. and BeiGene USA, Inc., alleging that BeiGene’s BRUKINSA® infringes a Pharmacyclics patent issued on June 13, 2023. BeiGene’s work is original, and we will vigorously defend against all allegations of patent infringement.
It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as BRUKINSA.
BeiGene has developed original and novel intellectual properties around BRUKINSA to demonstrate its differentiated profile. BRUKINSA’s broad global development and registration program includes more than 4,900 patients in 35 trials across 29 markets. BRUKINSA is now approved in more than 65 markets around the world and is approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL) in the United States.
Most recently, the ALPINE study, a head-to-head comparison between BRUKINSA and IMBRUVICA® in R/R CLL/SLL, demonstrated BRUKINSA’s superior efficacy (PFS and ORR) and safety (atrial fibrillation) over IMBRUVICA. The study also reported zero sudden cardiac death events for BRUKINSA versus a 1.9% rate for IMBRUVICA. Those results were published in the New England Journal of Medicine and presented as a simultaneous late breaker presentation at the American Society of Hematology meeting in December 2022.
As a science-based, global biotech company with over 9,400 people and operations on five continents, BeiGene highly values and respects valid and enforceable intellectual property rights. BeiGene remains confident in BRUKINSA’s intellectual property and will continue its mission to discover and develop innovative oncology treatments that are more efficacious and safer. BeiGene also remains committed to making medicines that are more affordable and accessible to cancer patients worldwide.
BeiGene is a global biotechnology company that is discovering and developing innovative oncology 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 9,400 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.
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 BeiGene’s protection of its intellectual property right; and BeiGene’s plans, commitments, aspirations, and goals under the heading “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; 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.
Kyle Blankenship, BeiGene