RED BANK, N.J., April 8, 2021 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced that the Company received a notification on April 2, 2021 from the U.S. Food and Drug
Administration (FDA), stating that, as part of its ongoing review
of the Company's Biologic License Application (BLA) for teplizumab
for the delay or prevention of clinical type 1 diabetes, the FDA
has identified deficiencies that preclude discussion of labeling
and post-marketing requirements/commitments at this time. The
FDA stated in the correspondence that the notification does not
reflect a final decision on the information under review.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
Additionally, during an informal discussion on April 2, 2021 regarding the agenda for the
upcoming Advisory Committee meeting scheduled for May 27, 2021, the FDA informed the
Company that it had completed its review of the data and
analysis submitted by the Company for its single, low-dose
pharmacokinetic/pharmacodynamic (PK/PD) bridging study conducted in
healthy volunteers. This study evaluated the PK/PD comparability of
drug product originating from drug substance manufactured by AGC
Biologics, which the Company plans to use for commercialization,
and drug product originating from historic drug substance
manufactured by Eli Lilly used for the TN-10 study submitted for
the teplizumab BLA. The FDA indicated that based on the data
it has reviewed to date, the Agency's position is that the PK
profiles of the two drug products evaluated in the PK/PD bridging
study were not comparable and that additional data would be
required before the FDA's considerations could be satisfied.
As a follow up, today, the FDA stated to the Company that it is
willing to discuss these issues concurrently with its ongoing
review.
The FDA intends to continue the review of clinical data
submitted in the BLA and to conduct the Advisory Committee meeting,
scheduled on May 27, 2021.
"While we believe the FDA's initial feedback will likely result
in a delay in timelines within which teplizumab has the potential
to be approved by FDA and be made available for at-risk T1D
patients, we believe in the comparability of the drug product
produced by our partner AGC biologics with Eli Lilly manufactured
product. We look forward to working closely with the Agency
to address its additional data requirement, so we can deliver
teplizumab to patients as soon as possible," said Ashleigh Palmer, CEO and Co-Founder, Provention
Bio. "Additionally, we remain enthusiastic about the clinical
efficacy and safety data submitted in connection with the BLA in
support of teplizumab's potential to address the high unmet needs
of at-risk T1D patients and look forward to meeting with the FDA's
Advisory Committee and hearing from patients, KOLs and other key
stakeholders next month."
Conference Call and Webcast Information:
Provention Bio will discuss these business updates via
conference call today at 5:00 pm ET. To access the call,
please dial 1-877-870-4263 (domestic) or 1-412-317-0790
(international) ten minutes prior to the start time and ask to be
connected to the "Provention Bio Call". An audio webcast will also
be available on the "Events and Webcasts" page of the Investors
section of the Company's website, www.proventionbio.com.
An archived webcast will be available on the Company's website
approximately two hours after the conference call.
About Teplizumab (PRV-031):
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb)
with a filed BLA under Priority Review by the FDA for the delay or
prevention of clinical type 1 diabetes (T1D) in at-risk
individuals. 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. It
correspondingly reduced the need for exogenous insulin use.
Teplizumab has been granted Breakthrough Therapy Designation by the
FDA and PRIME designation by the European Medicines Administration.
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 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.
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 regulatory
review of the BLA submission for teplizumab and the potential
approval and commercial launch of teplizumab, including timelines
relating to the same and the potential therapeutic effects and
safety of teplizumab. 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 for teplizumab or
other Company product candidates 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, 2020 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 Contacts:
Robert Doody, VP of Investor
Relations
rdoody@proventionbio.com
484-639-7235
Sam Martin, Argot Partners
Sam@argotpartners.com
212-600-1902
Media Contact:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
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SOURCE Provention Bio, Inc.