RED BANK, N.J., Nov. 2, 2020 /PRNewswire/ -- Provention Bio,
Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing autoimmune disease, today announced the
completion of the rolling submission of a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for teplizumab for the delay or prevention of clinical type one
diabetes (T1D) in at-risk individuals with the submission of the
chemistry, manufacturing and controls (CMC) and administrative
information modules.
The FDA has 60 days to review the final submission to determine
if the BLA is complete. If deemed complete, the application will be
considered acceptable for filing and review, and the FDA will set a
PDUFA goal date.
In August 2019, teplizumab was
granted Breakthrough Therapy Designation (BTD) by the FDA. As
afforded by the BTD, Provention has expressly requested a Priority
Review in conjunction with the completion of the final submission.
A Priority Review designation means FDA's goal is to take action on
an application within 6 months (compared to 10 months under
standard review). If approved by FDA, Teplizumab has the
potential to be the first disease-modifying therapy for T1D.
"Our submission of the final modules of the rolling BLA
represents a significant milestone for Provention Bio and a
critical step toward the potential first major advancement in T1D
therapeutics since insulin was introduced a century ago," stated
Ashleigh Palmer, CEO and Co-Founder,
Provention Bio. "We are extremely grateful to the entire Provention
team and our key clinical, regulatory and manufacturing partners,
as we could not have achieved this goal without their tireless
dedication and determination. We look forward to continuing on our
path toward changing the current treatment paradigm for T1D and, if
approved, bringing teplizumab, designated by the FDA as a
Breakthrough Therapy, to the U.S. market in 2021."
About Teplizumab (PRV-031):
Teplizumab is an anti-CD3
monoclonal antibody (mAb) being developed for the delay or
prevention of type 1 diabetes (T1D). More than 800 patients
have received teplizumab in multiple clinical studies involving
more than 1,000 subjects. In previous studies of newly
diagnosed patients, teplizumab consistently demonstrated the
ability to preserve beta-cell function, a measure of endogenous
insulin production, and correspondingly reduced the need for
exogenous insulin use. Teplizumab has been granted Breakthrough
Therapy Designation by the U.S. Food and Drug Administration (FDA)
and PRIME designation by the European Medicines Administration.
Provention Bio has completed a rolling submission of the Biologic
License Application for teplizumab for the delay or Prevention of
Clinical Type 1 Diabetes in At-risk Individuals. Provention
is currently also evaluating teplizumab in patients with newly
diagnosed insulin-dependent T1D (the Phase 3 PROTECT Study).
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 disease.
The Company has submitted a BLA to the FDA for its lead
investigational drug candidate, teplizumab, for the delay or
prevention of clinical type 1 diabetes (T1D) in at-risk
individuals. 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 or follow us on Twitter: @Proventiobio
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 FD. 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 regulatory review of the BLA submission for
teplizumab and the potential approval and commercial launch of
teplizumab, including timelines relating to the same, the potential
therapeutic effects of teplizumab and the Company's business plans.
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 the Company'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 approvals or clearances for teplizumab and
the potential for noncompliance with FDA 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; the Company's dependence upon third parties;
substantial competition; the Company's need for additional
financing and the risks listed under "Risk Factors" in the
Company's annual report on Form 10-K for the year
ended December 31, 2019, 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, whether as a result of new information, future
developments or otherwise, except as may be required by applicable
law. The information set forth herein speaks only as of the date
hereof.
Investor Contact:
Sam
Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.