RED BANK, N.J., Feb. 17, 2021 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated diseases, and Hangzhou
Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned
subsidiary of Huadong Medicine Co., Ltd., today announced that the
companies have entered into a strategic collaboration to develop
and commercialize PRV-3279, a DART® (bispecific antibody-based
molecule) targeting the B cell surface proteins CD32B and CD79B, in
Greater China (mainland
China, Hong Kong, Macau and Taiwan). Provention Bio will retain all
rights to PRV-3279 in the rest of the world.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
This collaboration provides Provention Bio access to the second
largest pharmaceutical market in the world via Huadong's
development, regulatory, and commercial capabilities. PRV-3279
represents the addition of an exciting autoimmune asset to
Huadong's growing autoimmunology portfolio. Provention Bio
plans to begin a Phase 2a trial of PRV-3279 in systemic lupus
erythematosus (SLE) in the second half of 2021 and expects a
portion of such trial to be conducted in China.
"Huadong's extensive development and commericalization
experience in the Greater China
region along with their strategic goal of being a leader in the
autoimmune therapeutic space created the opportunity for a strong,
strategic and mutually beneficial partnership between our two
companies," stated Ashleigh Palmer,
CEO and co-founder of Provention Bio. "This collaboration is a
reflection of PRV-3279's potential to intercept and prevent
life-altering and life-threatening autoimmune diseases and we look
forward to working closely with Huadong to develop and
commercialize PRV-3279 in Greater
China as we simultaneously further the development of the
program in the rest of the world."
"Provention Bio is a well regarded biopharmaceutical company
innovating to intercept and prevent serious autoimmune disorders.
PRV-3279 has the potential to intercept SLE disease progression and
improve the quality of life of people living with SLE," added
Liang Lu, Chairman of Huadong Medicine. "The SLE patient population is
substantial in China, with very
few treatment options. Leveraging Huadong's clinical and regulatory
capabilities, we will work closely with Provention Bio to
accelerate the clinical development of PRV-3279 in Greater China, to benefit SLE patients as soon
as possible."
Under the terms of the agreement, Provention Bio will receive an
upfront payment of $6 million, and up
to $11.5 million in funding over the
next three years to cover costs anticipated to be incurred by
Provention Bio in connection with research, development and
manufacturing activities. Provention Bio is eligible to receive
additional milestone payments of up to $172
million if certain regulatory and commercial objectives are
achieved. Provention Bio is also eligible to receive low-to-mid
double digit royalties as a percentage net sales of PRV-3279 by
Huadong in Greater China.
Huadong will be primarily responsible for development and
commercialization of PRV-3279 in Greater
China with the oversight of a joint steering committee
comprised of individuals from both companies. Provention Bio will
continue to be responsible for the development and
commercialization of PRV-3279 in the
United States and other geographies.
About PRV-3279:
PRV-3279 is a humanized diabody (a bispecific DART molecule)
targeting the B cell surface proteins, CD32B and
CD79B. Simultaneous engagement of the CD32B and CD79B
receptors triggers inhibition of B cell function and suppression of
autoantibody production, thereby regulating B cells without causing
depletion. Provention is initially developing PRV-3279 for the
interception of systemic lupus erythematosus (SLE), a chronic
autoimmune disorder characterized by an abnormal overactivation of
B cells and subsequent pathologic production of
auto-antibodies. PRV-3279 also has the potential to prevent or
reduce the immunogenicity of biotherapeutics, including but not
limited to gene therapy vectors and transgenes.
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical
company focused on advancing the development of investigational
therapies that may intercept and prevent debilitating and
life-threatening immune-mediated diseases. The Biologics License
Application (BLA) for teplizumab, its lead investigational drug
candidate, for the delay or prevention of clinical type 1 diabetes
in at-risk individuals has been filed by the U.S. Food and Drug
Administration (FDA). The Company's pipeline includes additional
clinical-stage product candidates that have demonstrated in
pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in other autoimmune diseases, including celiac
disease and lupus. Visit www.ProventionBio.com for more
information and follow us on Twitter: @ProventionBio.
About Huadong
Medicine:
Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese
pharmaceutical company based in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D,
manufacturing, distribution, sales and marketing capabilities.
Huadong Medicine's product portfolio
and pipeline are specialized in oncology, immunology, nephrology
and diabetes. The Company's annual revenue in 2019 exceeded 5
billion USD. Huadong Medicine has
12,000 employees, and one of the most extensive commercial coverage
and marketing capabilities in China. 'Patient Centered,
Science Driven' is Huadong's value. For additional information,
please visit www.eastchinapharm.com/en.
Internet Posting of Information:
Provention Bio, Inc. uses its
website, www.proventionbio.com, as a means of disclosing
material nonpublic information and for complying with its
disclosure obligations under Regulation F.D. Such disclosures will
be included on the Company's website in the "News" section.
Accordingly, investors should monitor this portion of the Company's
website, in addition to following its press
releases, SEC filings and public conference calls and
webcasts.
Forward Looking Statements:
Certain statements in this press release are forward-looking,
including but not limited to, statements relating to the Company's
studies, the potential safety, health benefits of and planned
research and development efforts for PRV-3279. These statements may
be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimate," "expect," and
"intend," among others. These forward-looking statements are based
on Provention's current expectations and actual results could
differ materially. There are a number of factors that could cause
actual events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, risks related to delays in, or failure to obtain FDA or
comparable foreign regulatory approvals or clearances and
noncompliance with FDA of comparable foreign agency regulations;
the potential impacts of COVID-19 on our business and financial
results; changes in law, regulations, or interpretations and
enforcement of regulatory guidance; uncertainties of patent
protection and litigation; dependence upon third parties;
substantial competition; our need for additional financing and the
risks listed under "Risk Factors" in our annual report on Form 10-K
for the year ended December 31, 2019, our quarterly reports on
form 10-Q, and any subsequent filings with the Securities and
Exchange Commission. As with any pharmaceutical under development,
there are significant risks in the development, regulatory approval
and commercialization of new products. Provention does not
undertake an obligation to update or revise any forward-looking
statement. The information set forth herein speaks only as of the
date hereof.
Investor Contacts:
Robert
Doody, VP of Investor Relations
rdoody@proventionbio.com
484-639-7235
Sam Martin, Argot Partners
Sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR
Communications
lori@ldrcommunications.com
917-553-6808
Huadong
Medicine:
Bo Chen
pretor@eastchinapharm.com
+86 571 8990 3290
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SOURCE Provention Bio, Inc.