- The study met its primary endpoint achieving clinically
meaningful and statistically significant reductions across all
TEV-‘749 dose groups versus placebo in the Positive and Negative
Syndrome Scale (PANSS) total score, a widely used assessment tool
for schizophrenia symptom severity
- TEV-‘749 was well tolerated, with no incidence of
post-injection delirium/sedation syndrome (PDSS) observed to date:
additional safety data is being collected as part of the long-term
follow-up SOLARIS study
- TEV-‘749 is being developed by Teva as a once-monthly
subcutaneous long-acting injection of olanzapine with the use of
SteadyTeq™ technology, a copolymer technology proprietary to
Medincell
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext:
MEDCL), today announced results from the efficacy portion of the
Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study
(SOLARIS) trial evaluating TEV-‘749 in adult patients with
schizophrenia compared to placebo. Results demonstrated that
TEV-‘749 met its primary endpoint as measured by a change in the
PANSS total score from baseline after 8 weeks compared to placebo.
TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to
Medincell that provides a controlled steady release of olanzapine,
the most prescribed 2nd generation antipsychotic for schizophrenia
in the U.S.1
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240508366301/en/
TEV-‘749 met its primary endpoint across all three dosing
groups, with mean difference in change in the Positive and Negative
Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71
points, -11.27 points, and -9.71 points versus placebo for the
high, medium, and low dose groups, respectively. These differences
from placebo were clinically meaningful and statistically
significant with adjusted P-values of <0.001 for each
comparison. Key secondary endpoints of CGI-S (Clinical Global
Impressions – schizophrenia) and PSP (Personal and Social
Performance Scale) total score were also statistically significant
after adjusting for multiplicity. No cases of PDSS have been
reported to date, after administration of approximately 80% of the
target injection number.
An estimated 3.5 million people are currently diagnosed with
schizophrenia in the U.S. It is a chronic, progressive, and
severely debilitating mental disorder that affects how one thinks,
feels and behaves. Currently, there is no long-acting olanzapine
treatment option available for schizophrenia that does not risk
post-injection delirium/sedation syndrome (PDSS). PDSS is
characterized by the sudden and unexpected onset of delirium or
sedation within the first several hours of receiving treatment and
has been associated with the intramuscular injection of long-acting
olanzapine.
“These encouraging results from the efficacy portion of our
Phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be
an effective long-acting treatment option for schizophrenia and
further show our dedication to advancing innovative science in
mental health and beyond,” said Eric Hughes, MD, PhD, Executive
Vice President of Global R&D and Chief Medical Officer at Teva.
“Schizophrenia can be a devastating disease for both the people
struggling with it as well their families. Schizophrenia is often a
chronic life-long disease, but by using medication consistently,
people can find the treatment help they deserve. This also has the
potential to reduce the burden for not only themselves, but their
caregivers and loved ones as well.”
The PANSS is composed of 3 subscales: Positive Scale, Negative
Scale, and General Psychopathology Scale. Each subscale is rated
with 1 to 7 points ranging from absent to extreme. Each of the 30
items is accompanied by a specific definition as well as detailed
anchoring criteria for all seven rating points. These seven points
represent increasing levels of psychopathology, as follows: 1-
absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe
7- extreme; the PANSS overall total score ranges from 30 to 210,
with a higher score indicating greater symptom severity. The
primary efficacy endpoint was measured by change from baseline to
week 8 against the PANSS total score.
“These data reinforce the potential of TEV-‘749 as a
subcutaneous long-acting injectable by using a proven molecule with
an established long-acting delivery system,” said Christoph
Correll, MD, Professor of Psychiatry at the Zucker School of
Medicine, Hempstead, NY and SOLARIS study co-ordinating
investigator. “Most patients with schizophrenia will experience one
or more relapses throughout their treatment journeys, so I very
much welcome the development of new and innovative long-acting
treatment options that may better fit into their lives.”
“The positive news from the phase III SOLARIS trial continues to
encourage ongoing innovation in treatment options for those living
with schizophrenia. We are thrilled to be part of this journey with
Teva through a strong partnership that allows us to leverage our
pioneering long-acting technology for the benefit of patients,”
said Christophe Douat, CEO of Medincell.
Additional efficacy and safety findings from the Phase 3 SOLARIS
study are planned for presentation at a medical meeting later this
year.
The long-term safety of TEV-‘749 and incidence of PDSS are also
being evaluated in the SOLARIS open-label study (period 2) with
safety data topline readout expected in the second half of
2024.
TEV-‘749 is an investigational once-monthly subcutaneous
long-acting injection of the 2nd generation antipsychotic
olanzapine and is not approved by any regulatory authority for any
use and its safety and efficacy are not established.
About Subcutaneous OLAnzapine Extended-Release Injection
Study (SOLARIS) SOLARIS is a multinational, multicenter,
randomized, double-blind, parallel-group, placebo-controlled study
to evaluate the efficacy, safety, and tolerability of olanzapine
extended-release injectable suspension for subcutaneous use as a
treatment in patients (ages 18-65 years) with schizophrenia. For
period one of the study (first 8 weeks), 675 patients were
randomized to receive a subcutaneous injection of once-monthly
TEV-‘749 (low, medium or high dose) or placebo in a 1:1:1:1 ratio.
For period two, which will last for up to 48 weeks, patients who
completed period one were randomized and equally allocated to one
of the three TEV-‘749 treatment groups. The end-of-treatment and
follow-up visits will be at 4 and 8 weeks after administration of
the last treatment dose, respectively. The primary objective of the
Phase 3 SOLARIS study was to evaluate the efficacy of TEV-‘749 in
adult patients with schizophrenia. A key secondary objective was to
further evaluate the efficacy of TEV-‘749 based on additional
parameters in adult patients with schizophrenia. A secondary
objective that is still ongoing through period two of the study is
to evaluate the safety and tolerability of TEV-‘749 in adult
patients with schizophrenia.
About Schizophrenia Schizophrenia is a chronic,
progressive and severely debilitating mental disorder that affects
how one thinks, feels and acts.2 Patients experience an array of
symptoms, which may include delusions, hallucinations, disorganized
speech or behavior and impaired cognitive ability.2,3,4
Approximately 1% of the world’s population will develop
schizophrenia in their lifetime, and 3.5 million people in the U.S.
are currently diagnosed with the condition.3,4 Although
schizophrenia can occur at any age, 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.4 Approximately 80% of patients experience
multiple relapses over the first five years of treatment, and each
relapse carries a biological risk of loss of function, treatment
refractoriness, and changes in brain morphology.5,6,7 Patients are
often unaware of their illness and its consequences, contributing
to treatment nonadherence, high discontinuation rates, and
ultimately, significant direct and indirect healthcare costs from
subsequent relapses and hospitalizations.2,3,4,5,6,7
About Teva Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global pharmaceutical leader with a
category-defying portfolio, harnessing our generics expertise and
stepping up innovation to continue the momentum behind the
discovery, delivery, and expanded development of modern medicine.
For over 120 years, Teva's commitment to bettering health has never
wavered. Today, the company’s global network of capabilities
enables its ~37,000 employees across 58 markets to push the
boundaries of scientific innovation and deliver quality medicines
to help improve health outcomes of millions of patients every day.
To learn more about how Teva is all in for better health, visit
www.tevapharm.com.
About Medincell Medincell is a clinical- and
commercial-stage biopharmaceutical licensing company developing
long-acting injectable drugs in many therapeutic areas. Our
innovative treatments aim to guarantee compliance with medical
prescriptions, to improve the effectiveness and accessibility of
medicines, and to reduce their environmental footprint. They
combine active pharmaceutical ingredients with our proprietary
BEPO® technology which controls the delivery of a drug at a
therapeutic level for several days, weeks or months from the
subcutaneous or local injection of a simple deposit of a few
millimeters, entirely bioresorbable. The first treatment based on
BEPO® technology, intended for the treatment of schizophrenia, was
approved by the FDA in April 2023, and is now distributed in the
United States by Teva under the name UZEDY® (BEPO® technology is
licensed to Teva under the name SteadyTeq™). We collaborate with
leading pharmaceutical companies and foundations to improve global
health through new treatment options. Based in Montpellier,
Medincell currently employs more than 140 people representing more
than 25 different nationalities. www.medincell.com
Note: TEV-‘749 is referenced as mdc-TJK in Medincell’s
documentation and corporate website.
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,
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. You can identify these
forward-looking statements by the use of words such as “should,”
“expect,” “anticipate,” “estimate,” “target,” “may,” “project,”
“guidance,” “intend,” “plan,” “believe” and other words and terms
of similar meaning and expression in connection with any discussion
of future operating or financial performance. Important factors
that could cause or contribute to such differences include risks
relating to: our ability to successfully develop olanzapine LAI
(TEV-‘749) for the treatment of adults with schizophrenia; our
ability to achieve successful results from the efficacy portion of
the Phase 3 trial for olanzapine LAI (TEV-‘749); our ability to
achieve successful results from the safety portion of the Phase 3
trial for olanzapine LAI (TEV-‘749); our ability to successfully
compete in the marketplace, including our ability to develop and
commercialize additional pharmaceutical products; our ability to
successfully execute our Pivot to Growth strategy, including to
expand our innovative and biosimilar medicines pipeline and
profitably commercialize the innovative medicines and biosimilar
portfolio, whether organically or through business development, and
to sustain and focus our portfolio of generic medicines; the
effectiveness of our patents and other measures to protect our
intellectual property rights; and other factors discussed in our
Quarterly Report on Form 10-Q for the first quarter of 2024, and in
our Annual Report on Form 10-K for the year ended December 31,
2023, including in the section captioned “Risk Factors.”
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.
__________________________________ 1 NPA TRx - MAT Jan 2024;
schizophrenia factors sourced from 2022 Analytics Link (IQVIA) 2
Substance Abuse and Mental Health Services Administration.
Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
Accessed November 2023. 3 Velligan DI, Rao S. The epidemiology and
global burden of schizophrenia. J Clin Psychiatry.
2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5. 4
Wander C. (2020). Schizophrenia: opportunities to improve outcomes
and reduce economic burden through managed care. The American
journal of managed care, 26(3 Suppl), S62–S68.
https://doi.org/10.37765/ajmc.2020.43013 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240508366301/en/
IR Ran Meir +1 (267) 468-4475
Yael Ashman +972 (3) 914 8262
Sanjeev Sharma +1 (973) 658 2700
Media Kelley Dougherty +1 (973) 832-2810
Eden Klein +972 (3) 906 2645
Medincell David Heuzé +33 6 98 52 47 50 /
david.heuze@medincell.com
Teva Pharmaceutical Indu... (NYSE:TEVA)
Gráfico Histórico do Ativo
De Jan 2025 até Fev 2025
Teva Pharmaceutical Indu... (NYSE:TEVA)
Gráfico Histórico do Ativo
De Fev 2024 até Fev 2025
