Er-Kim Announces Exclusive Distribution Agreement and Acceptance of Priority New Drug Application for BTK Inhibitor BRUKINSA® (zanubrutinib) in Turkey
ISTANBUL, Turkey, CAMBRIDGE, Mass. and BEIJING, China and [30 June 2021] -- Er-Kim and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biotechnology company, today announced an exclusive distribution agreement for Er-Kim to commercialize BeiGene’s BTK inhibitor BRUKINSA® (zanubrutinib) in Turkey and the acceptance of a priority new drug application (NDA) in Turkey for BRUKINSA® for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
“We are excited to work with Er-Kim, a leader in drug commercialization with extensive experience, to bring our potentially best-in-class BTK inhibitor to patients in Turkey,” commented Todd Yancey, M.D., SVP of Global Medical Affairs and New Market Development at BeiGene. “In addition, our planned expansion into new markets illustrates BeiGene’s patient-first principle and commitment to bringing meaningful treatments to patients worldwide.”
Cem Zorlular, CEO of Er-Kim added “We are thrilled by our deep partnership with BeiGene, which is built upon our commonly held principles prioritizing patient access and outcomes over all else. We are looking forward to working closely with all stakeholders to bring this potentially best-in-class product to the market as fast as possible.”
INDICATION
BRUKINSA is approved in the following indications and regions:
For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of adult patients with Waldenström’s Macroglobulinemia (WM) who have received at least one prior therapy (China, June 2021)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); and
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021).
*This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
About BeiGene
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
About Er-Kim
Er-Kim, a leading commercial partner for global biotech and pharma companies seeking to commercialize their products in Turkey, Middle East and Europe. In its 40-year of presence, Er-Kim commercialized over 150 original therapies from more than 50 leading global pharmaceutical companies. Additionally, Er-Kim operates in drug discovery for unmet needs in rare blood diseases and R&D providing cost-effective manufacturing of advanced medicinal products easing the economic burden of the healthcare system. For more information, visit www.er-kim.com
BeiGene 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 distribution agreement, new drug application and potential approval and commercialization of BRUKINSA® in Turkey, BeiGene’s planned expansion into new markets, 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 the BeiGene’s clinical development, regulatory, commercial, 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.
Er-Kim Contacts
Eylem Güngördü
+90 212 275 39 68
BeiGene Contacts
Investor Contact
Craig West or Gabrielle Zhou
+1 857-302-5189 or +86 10-5895-8058
Media Contact
Liza Heapes or Vivian Ni
+1 857-302-5663 or + 1 857-302-7596