Item 1.02. Termination of a Material Definitive Agreement.
On July 5, 2017, BeiGene, Ltd. ("BeiGene" or the "Company") and Celgene
Logistics Sàrl, now a wholly owned subsidiary of Bristol Myers Squibb Company
("BMS-Celgene"), entered into a License and Supply Agreement (the "Agreement")
pursuant to which the Company was granted the exclusive right to distribute and
promote BMS-Celgene's approved cancer therapies, ABRAXANE®, REVLIMID®, and
VIDAZA®, in China, excluding Hong Kong, Macau and Taiwan (the "Territory").
As previously disclosed by the Company, on March 25, 2020, the Chinese National
Medical Products Administration (the "NMPA") suspended the importation, sales
and use of ABRAXANE® in China supplied to the Company by BMS-Celgene under the
Agreement, and BMS-Celgene initiated a voluntary recall of ABRAXANE® in China.
This suspension was based on inspection findings at BMS-Celgene's contract
manufacturing facility in the United States.
As previously disclosed, the Company is currently engaged in arbitration
proceedings at the International Chamber of Commerce ("ICC") against BMS-Celgene
asserting that BMS-Celgene breached and continues to breach the terms and
conditions of the Agreement and a related quality agreement on the grounds,
among other things, that BMS-Celgene has failed to ensure the continuity and
adequacy of its supply of ABRAXANE® to the Company in accordance with good
manufacturing practices ("GMP"). In the arbitration proceeding, the Company is
seeking (i) a declaration that BMS-Celgene was and is in breach of the
Agreement, (ii) a declaration that BMS-Celgene acted with gross negligence
and/or willful misconduct, (iii) an award of damages, and (iv) such other relief
as the arbitrators deem appropriate.
As previously disclosed, the Company has been working with BMS-Celgene to
restore ABRAXANE® supply for the China market as soon as possible, including
through BMS-Celgene's remediation efforts at its existing manufacturing site in
the United States and/or an application to qualify an alternative manufacturing
site for China. On August 16, 2021, BMS-Celgene informed the Company that it
planned to file a supplementary application in the fourth quarter of 2021 to
register a new facility as the manufacturing site for ABRAXANE® for the China
market, with an initial projection that the application could be approved by the
NMPA in the fourth quarter of 2022.
Notice of Purported Termination
On October 6, 2021, BMS-Celgene delivered a notice to the Company purporting to
terminate the Agreement with respect to ABRAXANE® and providing 180-days' notice
that it was withdrawing ABRAXANE® from the range of products for sale or
distribution in the Territory pursuant to Section 2.6 of the Agreement (the
"Notice"). The Notice states:
"Indeed, as you are aware, due to the National Medical Products Association
decision to suspend the importation, sale, or use of Abraxane® in China on March
25, 2020, Celgene has been unable to manufacture Abraxane® for China and, thus,
has been unable to manufacture Abraxane® on a global basis as that term is used
in § 2.6 of the LSA.
Further, following the suspension by the National Medical Products
Administration of the manufacturing in Illinois, the manufacturing facility in
Phoenix, Arizona became the primary manufacturing facility for Abraxane®. In
July 2021, media fill testing at that facility revealed a failure. Following a
root cause investigation, corrective and preventative actions were implemented,
but testing resulted in the rejection of additional vials. Celgene is continuing
to correct the underlying issue, but all manufacturing production activities
with respect to Abraxane® have ceased at the Phoenix facility for the time being
and the U.S. Food and Drug Administration has been notified. This further
justifies Celgene's exercise of § 2.6 of the LSA.
BMS-Celgene has not advised the Company how long it will be unable to
manufacture ABRAXANE® at its Phoenix manufacturing facility or whether it has
the ability to manufacture ABRAXANE® at other facilities. The Company would be
happy to work with BMS-Celgene to help get the Phoenix manufacturing facility or
another facility qualified to restore the supply of ABRAXANE® for patients in
China as soon as possible.
The Company believes that the reasons stated in the Notice do not provide a
valid basis for terminating the Agreement with respect to ABRAXANE®, and that
the Notice is a tactical maneuver on the part of BMS-Celgene to reduce its
damages in the on-going arbitration proceedings described above. The Company
intends to contest the purported termination vigorously.
This Current Report on Form 8-K 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 plans,
objectives and intentions in the arbitration proceeding as well as the
projections or plans asserted by BMS-Celgene. 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 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 Current
Report is as of the date of this Current Report, and BeiGene undertakes no duty
to update such information unless required by law.
Item 8.01. Other Events.
On October 7, 2021, BeiGene announced that BRUKINSA® (zanubrutinib) has been
approved in Australia for the treatment of adult patients with Waldenström's
macroglobulinemia (WM) who have received at least one prior therapy or in first
line treatment for patients unsuitable for chemo-immunotherapy. The full text of
this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K
and is incorporated herein by reference.
On October 10, 2021, BeiGene announced that BRUKINSA® (zanubrutinib) has been
approved in Australia for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy. The full text of
this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K
and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit No. Description
99.1 Press Release titled "BeiGene Announces First
Regulatory Approval in Australia
for BRUKINSA® (Zanubrutinib) for Treatment of
Patients with Waldenström's
Macroglobulinemia", issued by BeiGene, Ltd. on
October 7, 2021.
99.2 Press Release titled "BeiGene Announces
BRUKINSA® (Zanubrutinib) Approved for
Treatment of Patients with Mantle Cell Lymphoma",
issued by BeiGene, Ltd. on
October 10, 2021.
104 The cover page from this Current Report on Form
8-K, formatted in Inline XBRL
© Edgar Online, source Glimpses