Study met its primary efficacy endpoint of
delaying time to relapse
Teva Pharmaceuticals Industries Ltd. (NYSE and TASE: TEVA) and
MedinCell (Euronext: MEDCL) today announced positive results for
study TV46000-CNS-30072 (the RISE study – The Risperidone
Subcutaneous Extended-Release Study), a Phase 3 clinical trial
designed to evaluate the efficacy of TV-46000/mdc-IRM (risperidone
extended-release injectable suspension for subcutaneous use) as a
treatment for patients with schizophrenia. Trial enrollment was
open to patients 13-65 years of age. In the RISE study, patients
treated with the investigational subcutaneous risperidone injection
either monthly (q1M) (n=183) or once every two months (q2M) (n=179)
experienced a statistically significant delay in time to relapse
versus placebo (n=181), the study's primary endpoint, with
p<0.0001 for each comparison. The investigational subcutaneous
risperidone injection q1M and q2M demonstrated a reduction of 80.0%
and 62.5% in the risk to relapse compared to placebo,
respectively.
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“Schizophrenia is a chronic, progressive and severe mental
disorder in which every relapse has the potential to cause
cognitive and psychosocial loss, worsen long-term outcomes, and
increase the overall burden for patients, caregivers, families, and
the healthcare system. We are encouraged by the results of the RISE
study, which demonstrated a marked delay in time to relapse for
patients in both the monthly and once-every-two months treatment
groups,” said Christer Nordstedt, MD, PhD, Senior Vice President,
Head of Specialty Clinical Development at Teva. “We look forward to
sharing more detailed results from the RISE study at future
scientific conferences, in peer-reviewed publications as well as
exploring options for a potential NDA submission using the
currently available clinical data.”
No new safety signals have been identified that are inconsistent
with the known safety profile of other risperidone formulations.
The second of Teva’s Phase 3 studies (TV46000-CNS-30078 – the SHINE
study) evaluating the long-term safety and tolerability of the
investigational subcutaneous risperidone injection across 331
patients is ongoing. Interim results align with the safety findings
of the RISE study.
“Long-acting injectables (LAI) for schizophrenia are considered
to be an innovative treatment option that we believe will make a
meaningful difference, yet they tend to be underutilized and only
introduced late in the course of the disease,” said Christophe
Douat, CEO at MedinCell. “The results of the RISE study are
promising and point to the potential for risperidone to be a
subcutaneously administered treatment option for patients with
schizophrenia.”
Teva will continue to lead the clinical development and
regulatory process and be responsible for commercialization of this
candidate treatment, with MedinCell eligible for development
milestones, royalties on net sales and future commercial
milestones.
About Risperidone Extended-Release Injectable Suspension for
Subcutaneous Use
The extended-release subcutaneous risperidone injection is an
investigational once-monthly or once-every-two-months injectable
formulation of the well-characterized and widely used atypical
antipsychotic risperidone for the treatment of schizophrenia. The
investigational subcutaneous risperidone injection utilizes a novel
polymer delivery platform that allows the product to be delivered
subcutaneously. The polymer delivery platform, in combination with
risperidone, allows for control of the rate and duration of drug
release and a range of dosing options. The investigational
subcutaneous risperidone injection has been studied extensively in
non-clinical and clinical studies, including a global Phase 3
clinical development program with two pivotal studies evaluating
investigational subcutaneous risperidone injection in
schizophrenia: The RISE Study (TV46000-CNS-30072) and the SHINE
Study (TV46000-CNS-30078). No new safety signals have been
identified that are inconsistent with the known safety profile of
other risperidone formulations.
About TV46000-CNS-30072 (The RISE Study – The Risperidone
Subcutaneous Extended-Release Study)
The RISE study was a multicenter, randomized, double-blind,
placebo-controlled study to evaluate the efficacy of risperidone
extended-release injectable suspension for subcutaneous use as a
treatment in patients (ages 13-65 years) with schizophrenia. 544
patients were randomized to receive a subcutaneous injection of
risperidone either q1M or q2M, or placebo in a 1:1:1 ratio. The
primary endpoint was time to impending relapse.
About TV46000-CNS-30078 (The SHINE Study)
The second of Teva’s Phase 3 studies; designed to evaluate the
long-term safety and tolerability of the investigational
subcutaneous risperidone injection administered q1M or q2M for up
to 56 weeks in 331 patients (ages 13-65 years) with schizophrenia.
The primary endpoint is the frequency of all adverse events,
including serious adverse events. This study is continuing; interim
results align with the safety findings of the RISE study
(TV46000-CNS-30072).
About Schizophrenia
Schizophrenia is a chronic, progressive and severely
debilitating mental disorder that affects how one thinks, feels and
acts.1 Patients experience an array of symptoms, which may include
delusions, hallucinations, disorganized speech or behavior and
impaired cognitive ability.1 Approximately 1% of the world’s
population will develop schizophrenia in their lifetime,2 and 3.5
million people in the U.S. are currently diagnosed with the
condition.3 Although schizophrenia can occur at any age,2 the
average age of onset tends to be in the late teens to the early 20s
for men, and the late 20s to early 30s for women.4 The long-term
course of schizophrenia is marked by episodes of partial or full
remission broken by relapses that often occur in the context of
psychiatric emergency and require hospitalization.2 Approximately
80% of patients experience multiple relapses over the first five
years of treatment,5 and each relapse carries a biological risk of
loss of function, treatment refractoriness, and changes in brain
morphology.6, 7 Patients are often unaware of their illness and its
consequences, contributing to treatment nonadherence, high
discontinuation rates,5 and ultimately, significant direct and
indirect healthcare costs from subsequent relapses and
hospitalizations.8,9
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding long-acting injectable risperidone for patients with
Schizophrenia, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals, the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory authorities
,the possibility of unfavorable new clinical data and further
analyses of existing clinical data
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our restructuring plan announced in
December 2017; our ability to attract, hire and retain highly
skilled personnel; our ability to develop and commercialize
additional pharmaceutical products; compliance with anti-corruption
sanctions and trade control laws; manufacturing or quality control
problems; interruptions in our supply chain, including due to
potential effects of the COVID-19 pandemic on our operations and
business in geographic locations impacted by the pandemic and on
the business operations of our suppliers; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; challenges associated
with conducting business globally, including adverse effects of the
COVID-19 pandemic, political or economic instability, major
hostilities or terrorism; significant sales to a limited number of
customers; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; our prospects and opportunities for growth if we sell
assets; and potential difficulties related to the operation of our
new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: our
ability to successfully defend against the U.S. Department of
Justice criminal charges of Sherman Act violations; increased legal
and regulatory action in connection with public concern over the
abuse of opioid medications in the U.S. and our ability to reach a
final resolution of the remaining opioid-related litigation; costs
and delays resulting from the extensive governmental regulation to
which we are subject or delays in governmental processing time due
to modified government operations due to the COVID-19 pandemic,
including effects on product and patent approvals due to the
COVID-19 pandemic; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M practices;
potential liability for patent infringement; product liability
claims; increased government scrutiny of our patent settlement
agreements; failure to comply with complex Medicare and Medicaid
reporting and payment obligations; and environmental risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release, in our
Quarterly Reports on Form 10-Q for the first, second and third
quarters of 2020 and in our Annual Report on Form 10-K for the year
ended December 31, 2019, including in the sections captioned "Risk
Factors” and “Forward Looking Statements.” Forward-looking
statements speak only as of the date on which they are made, and we
assume no obligation to update or revise any forward-looking
statements or other information contained herein, whether as a
result of new information, future events or otherwise. You are
cautioned not to put undue reliance on these forward-looking
statements.
About MedinCell
MedinCell is a clinical stage pharmaceutical company that
develops a portfolio of long-acting injectable products in various
therapeutic areas by combining its proprietary BEPO® technology
with active ingredients already known and marketed. Through the
controlled and extended release of the active pharmaceutical
ingredient, MedinCell makes medical treatments more efficient,
particularly thanks to improved compliance, i.e. compliance with
medical prescriptions, and to a significant reduction in the
quantity of medication required as part of a one-off or chronic
treatment. The BEPO® technology makes it possible to control and
guarantee the regular delivery of a drug at the optimal therapeutic
dose for several days, weeks or months starting from the
subcutaneous or local injection of a simple deposit of a few
millimeters, fully bioresorbable. Based in Montpellier, MedinCell
currently employs more than 130 people representing over 25
different nationalities.
1 Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D.
(2014). Schizophrenia: overview and treatment options. P & T: a
peer-reviewed journal for formulary management, 39(9), 638–645. 2
Biagi, E., Capuzzi, E., Colmegna, F., Mascarini, A., Brambilla, G.,
Ornaghi, A., Santambrogio, J., & Clerici, M. (2017).
Long-Acting Injectable Antipsychotics in Schizophrenia: Literature
Review and Practical Perspective, with a Focus on Aripiprazole
Once-Monthly. Advances in therapy, 34(5), 1036–1048. 3 SARDAA.
About Schizophrenia. Available at:
https://sardaa.org/resources/about-schizophrenia/. Accessed
December 2020. 4 NAMI. About Mental Illness: Schizophrenia.
Available at:
https://www.nami.org/About-Mental-Illness/Mental-Health-Conditions/Schizophrenia.
Accessed December 2020. 5 Emsley, R., & Kilian, S. (2018).
Efficacy and safety profile of paliperidone palmitate injections in
the management of patients with schizophrenia: an evidence-based
review. Neuropsychiatric disease and treatment, 14, 205–223. 6
Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of
relapse in schizophrenia. BMC Psychiatry 13, 50. 7 Andreasen, N.
C., et al. (2013). Relapse duration, treatment intensity, and brain
tissue loss in schizophrenia: a prospective longitudinal MRI study.
The American journal of psychiatry, 170(6), 609–615. 8 Pennington,
M., & McCrone, P. (2017). The Cost of Relapse in Schizophrenia.
PharmacoEconomics, 35(9), 921–936. 9 Jin, H., & Mosweu, I.
(2017). The Societal Cost of Schizophrenia: A Systematic Review.
PharmacoEconomics, 35(1), 25–42.
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Teva IR United States Kevin C. Mannix (215)
591-8912 Yael Ashman 972 (3) 914-8262 Teva PR United
States Doris Li (973) 265-3752 Israel Yonatan Beker 972
(54) 888 5898 MedinCell PR Contact France David Heuzé
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