OLDWICK, N.J., Sept. 24, 2019 /PRNewswire/ -- Provention
Bio, Inc., (Nasdaq: PRVB), a clinical-stage biopharmaceutical
company dedicated to intercepting and preventing immune-mediated
diseases, today reiterated its regulatory strategy regarding
PRV-031 (teplizumab) for the prevention or delay of clinical type 1
diabetes (T1D) in individuals at-risk of developing the disease.
Based on written communications from the U.S. Food and Drug
Administration (FDA) and FDA's designation of PRV-031 as a
breakthrough therapy, the Company believes that existing clinical
and non-clinical data for PRV-031 will be sufficient to support a
Biologics License Application (BLA) submission for PRV-031 in the
fourth quarter of 2020 for the at-risk indication. The
Company expects to meet with the FDA in the fourth quarter of 2019
to discuss this expedited development plan.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"Our interactions with the FDA in connection with the 'At Risk'
study of PRV-031 (teplizumab) provide us with the confidence to
submit a regulatory filing by the end of 2020,"
stated Ashleigh Palmer, CEO of Provention Bio. "The proceeds
from our financing will allow us to execute on our development
plans as we work closely with the FDA to bring teplizumab to
individuals at-risk of developing clinical T1D."
In the second quarter of 2019, the Company exchanged
correspondence with the FDA regarding the regulatory path forward
for PRV-031 for the prevention or delay of clinical T1D in
individuals at-risk for developing the disease. Specifically,
the FDA:
- Agreed, in principle, that the results from the "At-Risk"
study, together with supportive data from prior PRV-031 studies in
early onset T1D, may be sufficient for a BLA submission.
- Agreed that the safety database from the "At Risk" study and
prior clinical studies in patients with early onset T1D appears
adequate to support review of a BLA.
- Agreed that the current non-clinical package for PRV-031 is
adequate to support the At-Risk indication.
In a later letter granting Breakthrough Therapy Designation
(BTD), the FDA asked the Company to meet for
a multidisciplinary, comprehensive discussion of the Company's
PRV-031 program, including plans for expediting the manufacturing
development strategy.
In connection with the Company's follow-on financing and private
placement announced last week, the Company generated total net
proceeds of $62.7 million. The
net proceeds reflect an underwritten public offering of 5,750,000
shares of common stock at a price of $8.00 per share, including the full exercise of
the over-allotment option, as well as the issuance of 2,500,000
shares of common stock at a price of $8.00 per share in a private placement with
Amgen, Inc.
The net proceeds from the financing, together with its current
cash position, are expected to fund the Company's operations for
two years.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage
biopharmaceutical company leveraging a transformational drug
development strategy that is focused on the prevention or
interception of immune-mediated disease. Provention's mission
is to in-license, transform and develop therapeutic candidates
targeting the high morbidity, mortality and escalating costs of
autoimmune and inflammatory diseases including: type 1 diabetes
(T1D), Crohn's disease, celiac disease and lupus. Provention's
diversified portfolio includes advanced-stage product development
candidates that have undergone clinical testing by other
companies.
Forward-Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995, including but not limited to, statements relating to the
Company's studies. 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
failure to obtain FDA approvals or clearances and noncompliance
with FDA regulations; uncertainties of patent protection and
litigation; limited research and development efforts and 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,
2018 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 Contact:
Sam
Martin, Argot Partners
Sam@argotpartners.com
212-600-1902
Media Contact:
David
Rosen, Argot Partners
David.Rosen@argotpartners.com
212-600-1902
View original content to download
multimedia:http://www.prnewswire.com/news-releases/provention-bio-reiterates-regulatory-strategy-for-prv-031-and-announces-completion-of-follow-on-financing-300923957.html
SOURCE Provention Bio, Inc.