- 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
Regulatory News:
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
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.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.
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