LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced that the company has entered
into an agreement with Bristol Myers Squibb (BMS), whereby BMS has
obtained LianBio’s exclusive rights to develop and commercialize
mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Singapore
and Thailand, in conjunction with termination of the exclusive
license agreement LianBio previously entered into with MyoKardia,
Inc., now a wholly owned subsidiary of BMS, in August 2020 to
acquire such rights.
Under the terms of the agreement, LianBio will receive a
one-time payment of $350 million. In addition, LianBio will be
released from payment obligations of up to $127.5 million in
remaining milestone payments under the MyoKardia license
agreement.
In April 2023, the China National Medical Products
Administration (NMPA) accepted with Priority Review a New Drug
Application (NDA) for mavacamten for the treatment of adults with
symptomatic obstructive hypertrophic cardiomyopathy (oHCM). LianBio
received approval in Macau and Singapore for mavacamten for the
treatment of adults with symptomatic oHCM in 2023.
“Over the past three years, we have worked in close
collaboration with BMS to bring mavacamten to patients in Asia,”
said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “The
LianBio team executed a successful clinical development and
regulatory strategy in our territories and has built robust launch
infrastructure in anticipation of mavacamten’s potential approval
in China next year. As the global owner, BMS is ideally positioned
to continue to build on the value we created for mavacamten in
China and to optimize patient access to this important new medicine
across these territories.”
“Expanding our footprint in China by bringing innovative
medicines forward for patients suffering from serious diseases is
an important strategic objective for the company,” said Adam
Lenkowsky, Chief Commercialization Officer, Bristol Myers Squibb.
“Many patients who suffer from obstructive HCM symptoms have a
significant impact to their quality of life, which is why we’re
excited to build upon the strong foundation that LianBio has
created and to bring mavacamten to even more patients around the
globe.”
BMS expects to offer employment to certain LianBio personnel
working on the development and commercialization of mavacamten.
Centerview Partners LLC served as exclusive financial advisor to
LianBio, and Jefferies LLC served as financial advisor to BMS.
In conjunction with this transaction, LianBio’s Board of
Directors has initiated a comprehensive strategic review of the
company. The LianBio Board of Directors expects to provide an
update on its strategic review in the first half of 2024.
About MavacamtenCamzyos® (mavacamten) is the
first and only cardiac myosin inhibitor approved by the U.S. FDA,
indicated for the treatment of adults with symptomatic New York
Heart Association (NYHA) class II-III obstructive HCM to improve
functional capacity and symptoms, and in the European Union,
indicated for the treatment of symptomatic (NYHA, class II-III)
obstructive HCM in adult patients. It has also received regulatory
approvals in Australia, Brazil, Canada, Great Britain, Macau,
Singapore, South Korea and Switzerland. Camzyos is an allosteric
and reversible inhibitor selective for cardiac myosin. Camzyos
modulates the number of myosin heads that can enter “on actin”
(power generating) states, thus reducing the probability of force
producing (systolic) and residual (diastolic) cross-bridge
formation. Excess myosin actin cross bridge formation and
dysregulation of the super relaxed state are mechanistic hallmarks
of HCM. Camzyos shifts the overall myosin population towards an
energy sparing, recruitable, super relaxed state. In HCM patients,
myosin inhibition with Camzyos reduces dynamic LVOT obstruction and
improves cardiac filling pressures.
About Hypertrophic CardiomyopathyHypertrophic
cardiomyopathy (HCM) is a chronic, progressive disease in which
excessive contraction of the heart muscle and reduced ability of
the left ventricle to fill can lead to the development of
debilitating symptoms and cardiac dysfunction. HCM is estimated to
affect one in every 500 people globally. The most frequent cause of
HCM is mutations in the heart muscle proteins of the sarcomere. In
patients with both obstructive and non-obstructive HCM, exertion
can result in fatigue or shortness of breath, interfering with a
patient’s ability to participate in activities of daily living. HCM
has also been associated with increased risks of atrial
fibrillation, stroke, heart failure and sudden cardiac death.
In China, there are an estimated 1.1 million to 2.8 million
patients with HCM.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease.
LianBio is establishing an international infrastructure to position
the company as a partner of choice with a platform to provide
access to China and other Asian markets. For more information,
please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “expects”, “continue,”
“will,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the expectation that BMS will offer employment
to certain LianBio personnel, and the LianBio Board of Directors’
strategic review. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: LianBio’s ability to successfully
initiate and conduct its planned clinical trials and complete such
clinical trials and obtain results on its expected timelines, or at
all; LianBio’s plans to leverage data generated in its partners’
global registrational trials and clinical development programs to
obtain regulatory approval and maximize patient reach for its
product candidates; LianBio’s ability to identify new product
candidates and successfully acquire such product candidates from
third parties; competition from other biotechnology and
pharmaceutical companies; general market conditions; the impact of
changing laws and regulations and those risks and uncertainties
described in LianBio’s filings with the U.S. Securities and
Exchange Commission (SEC), including LianBio’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
filings with the SEC. Any forward-looking statements contained in
this press release speak only as of the date hereof, and LianBio
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Readers should not rely upon this information as current
or accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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