- Provention receives $20
million nonrefundable payment granting Sanofi exclusive
right of first negotiation to in-license teplizumab globally for
T1D
- U.S. copromotion agreement leverages Sanofi's in-market
infrastructure and established expertise in endocrinology to expand
reach, increase awareness and drive T1D screening
- Sanofi to invest $35 million
at a premium after a potential teplizumab FDA approval
- Investor Conference call at 8:30am
ET Today
RED
BANK, N.J. , Oct. 6, 2022
/PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB) (the
"Company"), a biopharmaceutical company dedicated to intercepting
and preventing immune-mediated diseases, today announced that the
Company has entered into a co-promotion agreement with Sanofi U.S.
for the launch of Provention's lead investigational drug candidate
teplizumab. The agreement enables Provention Bio to leverage
Sanofi's expertise, capabilities and commercial resources to
support the potential launch of teplizumab currently under review
by the U.S. Food and Drug Administration ("FDA"), for the delay of
clinical type 1 diabetes in at-risk individuals, with a user fee
goal date of November 17, 2022 for
the Biologics License Application.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
"This collaboration with Sanofi U.S. allows us to significantly
expand our planned commercial footprint during launch to support
increased screening and product awareness as we work to launch a
new therapy that, if approved, will dramatically impact the lives
of the patients and families we serve," said Jason Hoitt, Chief Commercial Officer,
Provention Bio. "In particular, Sanofi's long-standing
relationships with key U.S. healthcare professionals will
complement our focus on pediatric endocrinologists and help us
address a larger patient population with greater efficiency."
Olivier Bogillot, Head of U.S. General Medicines, Sanofi,
stated, "We are delighted by the prospect of supporting Provention
Bio in bringing to the U.S. what could become the first-in-class
therapy to change the course of type 1 diabetes. If approved,
Sanofi U.S. will leverage its existing world-class capabilities in
diabetes care to enhance efforts in both patient and healthcare
provider access. We are prepared to tap into all of our internal
expertise to support the successful launch of this innovative
therapy."
"The agreement brings significant resources to Provention and
allows us to advance our mission of delivering therapies which
intercept or delay debilitating and life-threatening autoimmune
diseases," said Ashleigh Palmer,
Co-Founder and Chief Executive Officer, Provention Bio. "We look
forward to working with our colleagues at Sanofi as we prepare to
deliver, if approved, the first-ever disease-modifying therapy for
T1D."
Co-Promotion
Agreement
Under the terms of the agreement, Sanofi will commit commercial
resources in the United
States, including diabetes field specialists, account
directors, field-based reimbursement and medical science liaisons
to expand the number of key healthcare professionals reached in
the United States. In exchange,
Provention will reimburse field force-related expenses that Sanofi
will incur in connection with commercializing teplizumab under the
agreement.
Provention retains all rights to teplizumab and maintains
responsibility for the commercialization strategy.
Right of First Negotiation to
Global Commercial Rights
The Company also granted Sanofi, in consideration of a one-time
payment of $20 million, an exclusive,
one-time right of first negotiation (ROFN) to obtain exclusive
global rights to commercialize teplizumab for Type 1 diabetes
indications in humans, subject to certain retained rights of the
Company to engage in discussions with third parties with respect to
certain transactions. Sanofi may exercise the ROFN, until
June 30, 2023, with an option to
extend within 2023 under certain conditions.
Equity Investment
Simultaneous with their entry into the co-promotion agreement,
the Company and Sanofi entered into a Securities Purchase Agreement
(the "Purchase Agreement"). Pursuant to the Purchase Agreement, if
teplizumab is approved by the FDA, Sanofi has agreed to purchase
$35 million of the Company's common
stock at a premium over the daily volume-weighted average per share
price for the five consecutive trading days prior to the closing
date. The closing date will be at Provention's discretion and would
occur no later than February 16,
2023.
BofA Securities acted as financial advisor to the Company on
this transaction.
For important information related to the terms of the
Co-Promotion Agreement and Securities Purchase Agreement, see
Provention Bio's Current Report on Form 8-K filed with the
Securities and Exchange Commission on October 6, 2022.
Conference Call and Webcast
Information
Provention Bio will discuss this business update via conference
call today at 8:30 am ET. To access the call, please dial
1-888-347-7861 (domestic) or 1-412-902-4247 (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
Teplizumab is an anti-CD3 monoclonal antibody that is being
developed for the delay of clinical T1D in at-risk individuals, as
indicated by the presence of two or more T1D-related
autoantibodies. There has been no disease-modifying innovation for
this life-impacting and life-threatening autoimmune disease since
the development of insulin a century ago. More than 800 patients
have received teplizumab in multiple clinical studies involving
more than 1,000 subjects. 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 of progression to Stage 3 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 the Company's
ability to leverage Sanofi's expertise, capabilities and commercial
resources to support the potential launch of teplizumab, the
potential that the collaboration with Sanofi to significantly
expand the Company's planned commercial footprint during launch,
the potential exercise of the ROFN by Sanofi, the potential
approval and commercialization of teplizumab and the potential
closing of the common stock offering to Sanofi. These statements
may be identified by the use of forward-looking words such as "may"
and "potential," 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 FDA disagreeing with the Company's
interpretation of data and analysis and information in the BLA
resubmission; delays in or failure to obtain FDA approvals for
teplizumab or other Company product candidates and the potential
for noncompliance with FDA regulations; any inability to
successfully work with FDA to address its concerns and requests in
a timely manner or at all during the review process for teplizumab,
including any inability to provide the FDA with data, analysis or
other information sufficient to support an approval of the BLA for
teplizumab; any inability to satisfactorily address matters related
to PK comparability, product quality, safety or any other FDA
requirements during the BLA review process to obtain an approval of
teplizumab; 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 quarterly report on Form 10-Q for the quarter ended
June 30, 2022 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:
Thierry Chauche, Chief Financial
Officer
tchauche@proventionbio.com
Brendan Strong
Argot Partners
Proventionbio@argotpartners.com
212-600-1902
Media Contact:
Kaelan
Hollon, VP of Communications
khollon@proventionbio.com
202-421-4921
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SOURCE Provention Bio, Inc.