OLDWICK, N.J., Aug. 11, 2020 /PRNewswire/ -- Provention
Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease, today
announced the appointment of John K. Jenkins, MD to the
Company's Board of Directors. Prior to taking his current position
as Principal, Drug and Biological Products, with Greenleaf Health,
an FDA-focused, strategic regulatory consulting firm, Dr. Jenkins
served as the Director of the Office of New Drugs (OND) at the
U.S. Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) from 2002 to 2017, where he was
responsible for supervising more than 1,000 agency employees and 19
product review divisions. During that time, Dr. Jenkins
oversaw the review of thousands of new drug applications and
biological licensing applications, as well as the approval of more
than 400 new molecular entities. Dr. Jenkins also served as a
member of the CDER Senior Leadership Team and was involved in broad
FDA policy initiatives, including negotiation and implementation of
the Prescription Drug User Fee and biosimilar programs.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"We are so very fortunate and honored to have Dr. Jenkins join
the Provention board," said Ashleigh
Palmer, CEO of Provention Bio. "John's unique and extensive
regulatory leadership, experience and insights will be invaluable
as our pipeline advances. We especially look forward to John's
strategic guidance and expert contributions as we advance
teplizumab through the latter stages of regulatory review and
potential approval, and transition Provention to a commercial
organization. John's appointment not only reinforces our commitment
to ensure this corporate advancement is effectively governed at
board level, it also clearly signals our strategic intent to take
full advantage of teplizumab's substantial potential lifecycle
opportunities, including, if regulatory approval is received,
working with the FDA on post-marketing label expansion which may
include patients below eight years of age and potential redosing
with the goal to indefinitely delay or prevent the onset of
insulin-dependent type 1 diabetes in presymptomatic patients."
"I am extremely pleased to have this opportunity to join
Provention Bio at such an exciting time, as the Company shifts its
focus to potential approval and commercialization of teplizumab and
subsequent post-marketing phases of development. I'm especially
impressed by the results of the recent "At Risk" TN-10 study
showing that a single course of teplizumab significantly delayed
the onset of insulin-dependent type 1 diabetes in pre-symptomatic
patients by a median of approximately three years as compared to
placebo. Provention has a unique opportunity to transform the type
1 diabetes treatment landscape, and I look forward to working with
the board and leadership team to advance our shared mission to
improve the lives of patients with type 1 diabetes, and other
patients with serious autoimmune diseases," said Dr. Jenkins.
Dr. Jenkins began his FDA career in 1992 as a medical officer in
the Division of Oncology and Pulmonary Drug Products. He
subsequently served as Pulmonary Medical Group Leader and Acting
Division Director before being appointed as Director of the
Division of Pulmonary Drug Products in 1995. He became the Director
of the Office of Drug Evaluation II in 1999 and remained in that
position until he was appointed Director of OND in 2002.
Dr. Jenkins is board certified in internal medicine and
pulmonary diseases by the American Board of Internal Medicine. He
received his medical degree from the University of Tennessee, Memphis and completed his
post-graduate medical training in internal medicine, pulmonary
diseases, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia in Richmond.
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical
company leveraging a transformational drug development strategy
focused on the prevention or interception of immune-mediated
disease. Provention's mission is to source, transform and develop
therapeutic candidates targeting the high morbidity, mortality and
escalating costs of autoimmune diseases. Provention's diversified
portfolio includes teplizumab, a clinical-stage candidate that has
been shown in a clinical study to delay the onset of
insulin-dependent type 1 diabetes (T1D) in at-risk patients during
the presymptomatic phase of the disease as compared to placebo. The
Company's portfolio includes additional clinical product
development 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.
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 health benefits of, potential regulatory
approval of, potential initial label and expansion opportunities
of, and potential commercial efforts and success of teplizumab and
planned research and development efforts for the Company's
investigational product. 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 approvals or clearances and
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;
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 Contact:
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808
View original content to download
multimedia:http://www.prnewswire.com/news-releases/john-k-jenkins-md-joins-provention-bio-board-of-directors-301109657.html
SOURCE Provention Bio, Inc.