Companies collaborating to expand access to
TZIELD™ (teplizumab-mzwv), the first approved disease-modifying
therapy for type 1 diabetes
RED
BANK, N.J., Feb. 13,
2023 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB) (the "Company"), a biopharmaceutical company dedicated to
intercepting and preventing immune-mediated diseases, today
announced the closing of the $35
million equity investment from Sanofi US under the
previously announced Co-Promotion Agreement and Securities Purchase
Agreement (the "Purchase Agreement").
"Our Sanofi co-promotion agreement, together with this equity
investment, bring significant financial and human capital to
Provention in support of our commercial launch of TZIELD
(teplizumab-mzwv), more than doubling our original field presence
in the U.S.," said Jason Hoitt,
Chief Commercial Officer, Provention Bio. "TZIELD is the first
immunomodulatory therapy approved to delay the onset of Stage 3
type 1 diabetes (T1D) in adults and pediatric patients aged 8 years
and older with stage 2 T1D. TZIELD's recent FDA approval advances
our purpose to intercept autoimmunity in its earlier stages, rather
than waiting to manage end-stage disease when symptoms,
irreversible tissue damage, and serious complications appear. Over
the past few months, we have been partnering with our colleagues at
Sanofi to increase awareness and access to TZIELD. The Provention
Bio COMPASS™ patient support team has been working closely
with prescribing physicians and their eligible T1D patients to
efficiently navigate reimbursement and insurance coverage processes
and gain access to our game-changing Stage 2 T1D therapeutic
option."
Olivier Bogillot, Head of U.S. General Medicines, Sanofi,
stated, "We are excited to continue supporting Provention Bio in
the U.S. commercial launch of TZIELD, the first approved
disease-modifying therapy for type 1 diabetes. We have been
leveraging our established infrastructure and expertise in
endocrinology to enhance patient and healthcare provider access.
The closing of our equity investment in Provention further
strengthens this key collaboration."
Pursuant to the Purchase Agreement, Sanofi purchased 2,712,497
shares of the Company's common stock, par value $0.0001 per share, at a price of $12.90 per share, representing a total investment
of $35 million.
About TZIELD
TZIELD (teplizumab-mzwv) is a CD3-directed antibody indicated to
delay the onset of Stage 3 T1D in adults and pediatric patients
aged 8 years and older with Stage 2 T1D. TZIELD injection is
supplied as a sterile, preservative-free, clear and colorless
solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for
intravenous use. TZIELD should be administered by intravenous
infusion (over a minimum of 30 minutes) once daily for 14 days.
Please see full prescribing information for the dosing
schedule.
If a patient needs help paying for TZIELD, Provention Bio's
Patient Assistance Program may be able to help. While co-pay
amounts vary based on individual coverage, with the Provention Bio
Copay Program, commercially or privately insured individuals
enrolled in COMPASS may pay as little as $0 for TZIELD.
If a patient qualifies, their COMPASS Navigator can help enroll
them into the program so they may be able to lower their
out-of-pocket costs. Interested patients and healthcare
providers can contact COMPASS for questions about our available
assistance programs at COMPASS@proventionbio.com and
1-844-778-2246, Monday through Friday from 8AM-8PM EST.
Important Safety Information about TZIELD
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): CRS occurred in
TZIELD-treated patients during the treatment period and through 28
days after the last drug administration. Prior to TZIELD treatment,
premedicate with antipyretics, antihistamines and/or antiemetics,
and treat similarly if symptoms occur during treatment. If severe
CRS develops, consider pausing dosing for 1 day to 2 days and
administering the remaining doses to complete the full 14-day
course on consecutive days; or discontinue treatment. Monitor liver
enzymes during treatment. Discontinue TZIELD treatment in patients
who develop elevated alanine aminotransferase or aspartate
aminotransferase more than 5 times the upper limit of normal (ULN)
or bilirubin more than 3 times ULN.
- Serious Infections: Use of TZIELD is not
recommended in patients with active serious infection or chronic
infection other than localized skin infections. Monitor patients
for signs and symptoms of infection during and after TZIELD
administration. If serious infection develops, treat appropriately,
and discontinue TZIELD.
- Lymphopenia: In clinical trials, lymphopenia
occurred in 78% of TZIELD-treated patients. For most patients,
lymphocyte levels began to recover after the fifth day of treatment
and returned to pretreatment values within two weeks after
treatment completion and without dose interruption. Monitor white
blood cell counts during the treatment period. If prolonged severe
lymphopenia develops (<500 cells per mcL lasting 1 week or
longer), discontinue TZIELD.
- Hypersensitivity Reactions: Acute hypersensitivity
reactions including serum sickness, angioedema, urticaria, rash,
vomiting and bronchospasm occurred in TZIELD-treated patients. If
severe hypersensitivity reactions occur, discontinue TZIELD and
treat promptly.
- Vaccinations: The safety of immunization with
live-attenuated (live) vaccines in TZIELD-treated patients has not
been studied. TZIELD may interfere with immune response to
vaccination and decrease vaccine efficacy. Administer all
age-appropriate vaccinations prior to starting TZIELD.
-
- Administer live vaccines at least 8 weeks prior to treatment.
Live vaccines are not recommended during treatment, or up to 52
weeks after treatment.
- Administer inactivated (killed) vaccines or mRNA vaccines at
least 2 weeks prior to treatment. Inactivated vaccines are not
recommended during treatment, or 6 weeks after completion of
treatment.
ADVERSE REACTIONS: Most common adverse reactions
(>10%) were lymphopenia, rash, leukopenia, and headache.
Call your doctor for medical advice about side effects. You
are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088 or contact Provention Bio at 1-844-778-2246.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: A lactating woman may consider pumping
and discarding breast milk during and for 20 days after TZIELD
administration.
Please see accompanying Prescribing Information.
About Sanofi US Co-Promotion
In October 2022, Provention entered into a co-promotion
agreement with Sanofi US for the launch of TZIELD. 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 TZIELD and maintains
responsibility for the commercialization strategy.
About Provention Bio, Inc.
Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage
biopharmaceutical company focused on advancing the development and
commercialization of investigational therapies that may intercept
and prevent debilitating and life-threatening immune-mediated
diseases. The Company's pipeline includes clinical-stage product
candidates that have demonstrated in pre-clinical or clinical
studies proof-of-mechanism and/or proof-of-concept in autoimmune
diseases, including T1D, 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 potential
benefits of TZIELD, plans to bring TZIELD to patients and related
commercialization plans with Sanofi and the potential benefits of
the partnership between the companies. These statements may be
identified by the use of forward-looking words such as "may" and
"advance," 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, failure to maintain FDA approval for TZIELD; the
planned commercial launch in the U.S. for TZIELD may not be
successful in part or at all for various reasons including the
actual market size and drug supply needed may not be consistent
with the company's expectations and its executed commercial
readiness plans; the degree to which TZIELD is accepted by patients
and prescribed by physicians; the efficiency of our manufacturing,
sales, distribution and specialty pharmacy network in getting
TZIELD to the market and future economic, competitive,
reimbursement and regulatory conditions that could negatively
impact the commercial launch of TZIELD; the post-marketing
commitment studies for TZIELD may not yield data consistent with
prior results; we may not be able to execute on our business plans
including meeting our expected or planned regulatory milestones and
timelines, clinical development plans and successfully bringing our
product candidates to market, for various reasons, including
factors outside of the Company's control, such as possible
limitations of Company financial and other resources, competition,
manufacturing limitations that may not be anticipated or resolved
for in a timely manner or at all, and regulatory, court or agency
decisions, such as decisions by the United States Patent and
Trademark Office with respect to patents that cover our product
candidates, 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; competition and the risks listed under
"Risk Factors" in the Company's quarterly report on Form 10-Q for
the quarter ended September 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
Provention Bio and the Provention Bio logo are registered
Trademarks of Provention Bio, Inc. TZIELD and Provention Bio
COMPASS are trademarks of Provention Bio, Inc.
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SOURCE Provention Bio, Inc.