Assembly Biosciences, Inc. (Nasdaq: ASMB) and BeiGene, Ltd.
(NASDAQ: BGNE; HKEX: 06160), today announced that the companies
have entered into a collaboration in China for Assembly’s portfolio
of three clinical-stage core inhibitor candidates for the treatment
of patients with chronic hepatitis B virus (HBV) infection.
Under the terms of the agreement, Assembly has granted BeiGene
exclusive rights to develop and commercialize ABI-H0731, ABI-H2158
and ABI-H3733 in China, including Hong Kong, Macau, and Taiwan.
ABI-H0731 and ABI-H2158 are both in ongoing Phase 2 clinical trials
and ABI-H3733 is in Phase 1 development. BeiGene will be
responsible for development, regulatory submissions, and
commercialization in China. Assembly retains full worldwide rights
outside of the partnered territory for the Company’s HBV
portfolio.
Assembly will receive an upfront cash payment of $40 million and
is eligible to receive up to approximately $500 million in
potential development, regulatory and net sales milestone payments
pending successful development and commercialization of the
licensed candidates. In addition, Assembly is eligible to receive
tiered royalties of net sales. BeiGene will contribute initial
funding for clinical development in China, after which the
development costs for the territory will be shared equally by the
parties.
“This collaboration with Assembly expands our portfolio beyond
oncology to liver diseases, which are highly prevalent and
represent a high unmet need in China,” said John Oyler, Co-Founder,
Chairman and Chief Executive Officer of BeiGene. “We are thrilled
to collaborate with the Assembly team that has industry-leading
expertise in this area to advance novel treatments for hepatitis B,
with the ultimate goal of developing a cure. Since one-third of the
world’s individuals living with chronic hepatitis B are in China,
we are committed to leveraging our capabilities to further develop
these novel therapies for patients with HBV infection.”
“Our goal for China has been to find a strong, trustworthy
partner with a proven track record, and we are excited to
collaborate with the experienced team at BeiGene, a premier
scientific partner in our industry,” said John McHutchison, AO, MD,
Chief Executive Officer and President of Assembly Biosciences.
“BeiGene has world-class operations in China, enabling us to
accelerate the clinical development and commercialization of our
core inhibitors for this important market as well as globally. With
up to 90 million individuals infected with HBV in China and given
the significant unmet medical need, we and BeiGene are committed to
advancing our novel core inhibitors for patients living with this
chronic disease.”
Assembly currently projects its $249 million in cash at March
31, 2020, together with these additional near-term sources of
funding, will extend its funding of operations into the second half
of 2022.
Goldman Sachs & Co. LLC is acting as exclusive financial
advisor to Assembly Biosciences.
Assembly’s Webcast and Conference Call Today
Management from Assembly Biosciences will host a webcast and
conference call today at 5:30 am PT / 8:30 am ET. The live audio
webcast with accompanying slides may be accessed through the
“Events & Presentations” page in the “Investors” section of
Assembly’s website at
https://investor.assemblybio.com/events-presentations.
Alternatively, participants may dial (866) 438-0453 (domestic) or
(409) 220-9366 (international) and refer to conference ID 4380778.
Call participants are encouraged to connect at 5:15 am PT / 8:15 am
ET to ensure a timely connection to the call or to utilize the
webcast link for listen-only access.
The archived webcast will be available on Assembly’s website
beginning approximately two hours after the event and will be
archived and available for replay for at least 30 days after the
event.
About Assembly Biosciences’ HBV Core Inhibitor
Portfolio Assembly’s HBV portfolio includes three
clinical-stage small molecule candidates, all of which are HBV core
inhibitors that target multiple steps of the HBV lifecycle. In
Phase 2 clinical trials, first-generation core inhibitor ABI-H0731
administered with nucleos(t)ide analogue reverse transcriptase
inhibitor (NrtI) therapy has been well-tolerated, has shown
statistically superior antiviral activity in HBV DNA suppression
compared to NrtI therapy alone, and has demonstrated significant
declines in pgRNA that may indicate decreased cccDNA levels. In the
ongoing Phase 2 open-label extension trial, Assembly is beginning
to transition patients off combination therapy, to then monitor for
sustained virologic response (SVR).
Assembly’s HBV portfolio also includes two more potent,
second-generation candidates, ABI-H2158 in a Phase 2 clinical trial
and ABI-H3733 in Phase 1 development.
Clinical data from ABI-H0731 and ABI-H2158 have been selected
for presentation at the European Association for the Study of the
Liver’s (EASL) Digital International Liver Congress, August 27-29,
2020.
About HBVChronic hepatitis B virus (HBV)
infection is a debilitating disease of the liver that afflicts over
250 million people worldwide with up to 90 million people in China,
as estimated by the World Health Organization. HBV is a global
epidemic that affects more people than hepatitis C virus (HCV) and
HIV infection combined—with a higher morbidity and mortality rate.
HBV is a leading cause of chronic liver disease and need for liver
transplantation, and up to one million people worldwide die every
year from HBV-related causes.
The current standard of care for patients with chronic HBV
infection is life-long suppressive treatment with medications that
reduce, but do not eliminate, the virus, resulting in very low cure
rates. There is a significant unmet need for new therapies to treat
HBV.
About Assembly Biosciences Assembly
Biosciences, Inc. is a clinical-stage biotechnology company
developing innovative therapeutics targeting hepatitis B virus
(HBV) and diseases associated with the microbiome. The HBV program
is focused on advancing a new class of potent, oral core inhibitors
that have the potential to increase cure rates for chronically
infected patients. The microbiome program is developing novel
oral live microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain
identification and selection, GMP manufacturing expertise and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information,
visit assemblybio.com.
About BeiGene BeiGene is a global,
commercial-stage biotechnology company focused on discovering,
developing, manufacturing, and commercializing innovative medicines
to improve treatment outcomes and access for patients worldwide.
Its 4,100+ employees in China, the United States, Australia, and
Europe are committed to expediting the development of a diverse
pipeline of novel therapeutics for cancer. BeiGene currently
markets two internally-discovered oncology products: BTK inhibitor
BRUKINSA® (zanubrutinib) in the United States and China, and
anti-PD-1 antibody tislelizumab in China. BeiGene also markets or
plans to market in China additional oncology products licensed from
Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS)
company, and EUSA Pharma. To learn more about BeiGene, please visit
www.beigene.com and follow BeiGene on Twitter at @BeiGeneUSA.
Assembly’s Forward-Looking Statements The
information in this press release contains forward-looking
statements that are subject to certain risks and uncertainties that
could cause actual results to materially differ from those
projected or implied. These risks and uncertainties include:
Assembly and BeiGene’s ability to initiate and complete clinical
trials for ABI-H0731, ABI-H2158, and ABI-H3733 in the currently
anticipated timeframes in China; safety and efficacy data from
clinical studies may not warrant further development of Assembly’s
core inhibitor product candidates; the products subject to the
collaboration may not achieve future milestones or be eligible for
royalties; ABI-H0731, ABI-H2158 and ABI-H3733 may not receive
regulatory approval under the currently anticipated timelines, or
at all; Assembly’s core inhibitor products may not be
differentiated from other companies’ candidates; Assembly may not
observe sustained virologic response (SVR) in patients who are
treated with its core inhibitors; and other risks identified from
time to time in Assembly’s reports filed with the U.S. Securities
and Exchange Commission (the SEC). All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. Readers are cautioned not to rely on
these forward-looking statements. Assembly intends such
forward-looking statements to be covered by the safe harbor
provisions contained in Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. More information about the risks and uncertainties
faced by Assembly are more fully detailed under the heading “Risk
Factors” in Assembly’s filings with the Securities and Exchange
Commission, including its most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Except as required by law, Assembly assumes no obligation to update
publicly any forward-looking statements, whether resulting from new
information, future events or otherwise.
BeiGene’s 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 future
development and potential commercialization of the licensed product
candidates; potential payments payable to Assembly; the potential
of the licensed product candidates to treat and possibly achieve
SVR in HBV patients; and the parties’ commitments and the potential
benefits of the collaboration. 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 products and drug
candidates, if approved; BeiGene's ability to obtain and maintain
protection of intellectual property for its technology and drugs;
BeiGene's reliance on third parties to conduct drug development,
manufacturing and other services; BeiGene’s limited operating
history and BeiGene's ability to obtain additional funding for
operations and to complete the development and commercialization of
its drug candidates; the impact of the COVID-19 pandemic on the
Company’s clinical development, 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.
Assembly ContactsInvestors and Media:Lauren
GlaserSenior Vice President, Investor Relations and Corporate
Affairs(415) 521-3828lglaser@assemblybio.com
Amy Figueroa, CFAInvestor Relations Consultant(415)
366-5158afigueroa@assemblybio.com
Solebury TroutLuke Brown(646) 378-2944lbrown@troutgroup.com
BeiGene Contacts Investors:Craig West or
Gabrielle Zhou(857) 302-5189 or +86 010 8514 8822ir@beigene.com
Media:Liza Heapes or Vivian Ni(857) 302-5663 or (857)
302-7596media@beigene.com
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