BeiGene Announces Settlement of Litigation Against Generic Filer of BRUKINSA

Published 25 days ago via Business Wire

Agreement provides for generic entry of innovative BTK inhibitor in 2037

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company which intends to change its name to BeOne Medicines Ltd., today announced it has entered into a settlement agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd. resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of BRUKINSA® (zanubrutinib) in the U.S.

Under the terms of the agreement, MSN will not be able to sell a generic version of BRUKINSA earlier than June 15, 2037, subject to potential acceleration or extension under certain customary circumstances. The composition of matter patent for BRUKINSA, expiring in April 2034, was not challenged by MSN in the litigation.

“Developed internally, BRUKINSA is a best-in-class BTK inhibitor with the broadest label of any medicine in its class globally. This settlement reaffirms our confidence in the intellectual property protecting this groundbreaking treatment and its exclusivity. Approved in over 70 markets for treating diverse B-cell malignancies, BRUKINSA exemplifies the strength of our R&D program and reinforces our commitment to delivering transformative medicines around the world,” said Chan Lee, General Counsel at BeiGene. “We continue to advance our innovative oncology treatments, relying on a robust patent system to safeguard our investment. Our focus remains on expanding access to this therapy and future innovations for cancer patients globally.”

The settlement resolves all patent litigation brought by BeiGene against companies that sought to market generic versions of BRUKINSA. BeiGene and Sandoz Inc. previously filed a joint stipulation to dismiss patent litigation brought by BeiGene in response to Sandoz’s ANDA seeking approval to market a generic version of BRUKINSA.

The Company recently announced its intent to change its name to BeOne, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

About BeiGene

BeiGene, which plans to change its name to BeOne Medicines, 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 nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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 strength of BeiGene’s R&D program; BeiGene’s commitment to globally deliver transformative medicines; the ability of BeiGene to expand access to BRUKINSA; and BeiGene’s plans, commitments, aspirations and goals under the caption “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, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and 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.

To access BeiGene media resources, please visit our News & Media site.

Contacts