TIDMINDV
RNS Number : 5195Y
Indivior PLC
09 May 2019
Indivior Enters into Exclusive License Agreement with HLS
Therapeutics for PERSERIS(TM) (risperidone) in Canada
Slough, UK and Richmond, VA, May 9, 2019 - Indivior PLC (LON:
INDV) ("Indivior" or the "Group") today announced that it has
entered into a definitive license agreement with HLS Therapeutics
Inc. (TSX: HLS) ("HLS") for exclusive commercialization rights to
PERSERIS(TM) (risperidone) in Canada.
HLS is a specialty pharmaceutical company focused on acquiring
and commercializing late-stage products for the Canadian market.
Commercially, if approved, PERSERIS(TM) would be complementary to
HLS' product Clozaril(R) (clozapine), an atypical antipsychotic
which, in Canada, is indicated for the management of the symptoms
of treatment-resistant schizophrenia ("TRS"). HLS employs a unique
branded platform called the Clozaril(R) Support and Assistance
Network ("CSAN(R)") that includes value-added treatment provider
and patient services to support Clozaril(R). PERSERIS, if approved,
could benefit from the CSAN(R) offerings.
Shaun Thaxter, Chief Executive Officer of Indivior, said, "We
understand the challenges of patients living with schziophrenia and
are pleased that PERSERIS may become available to Canadian patients
through HLS. HLS has an experienced clinical and regulatory team
with a strong track record of commercialization success in Canada,
as well as a specialized team dedicated to psychiatry. In addition,
there are significant synergies between PERSERIS, HLS' product
Clozaril and HLS' unique CSAN platform. Given these advantages, we
are confident that HLS is the right partner for Indivior and we
look forward to the potential growth we see for PERSERIS in Canada
with HLS."
Under the terms of the agreement, Indivior has granted an
exclusive license to HLS to file and commercialize PERSERIS in
Canada. In addition, Indivior will provide technical assistance to
file the Canadian dossier and will enter into a supply agreement to
furnish finished goods to HLS for sale in the territory.
Indivior will receive $1 million upon signing of the definitive
agreement and a near-term payment of $4 million contingent upon
achieving certain regulatory and pre-commercial milestones. Upon
commercialization in the territory, Indivior is also eligible to
receive escalating double-digit royalties based on annual net
sales.
About PERSERIS
IN CANADA, PERSERIS IS AN INVESTIGATIONAL PRODUCT THAT HAS NOT
UNDERGONE REVIEW BY HEALTH CANADA
Once-monthly PERSERIS (risperidone) for extended-release
injectable suspension has been approved by the US FDA for the
treatment of schizophrenia in adults.
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. The name is the
fusion of the words individual and endeavour, and the tagline
"Focus on you" makes the Company's commitment clear. Indivior is
dedicated to transforming addiction from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of opioid dependence treatments, Indivior has a strong
pipeline of product candidates designed to both expand on its
heritage in this category and address other chronic conditions and
co-occurring disorders of addiction, including alcohol use disorder
and schizophrenia. Headquartered in the United States in Richmond,
VA, Indivior employs more than 800 individuals globally and its
portfolio of products is available in over 40 countries worldwide.
Visit www.indivior.com to learn more.
Contact:
Jason Thompson
804-402-7123
Vice President, Investor Relations
jason.thompson@indivior.com
PERSERIS(TM) (risperidone) for extended-release injectable
suspension
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
PERSERIS(TM) (risperidone) is indicated for the treatment of
schizophrenia in adults.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
-- Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death.
-- PERSERIS is not approved for use in patients with dementia-related psychosis.
CONTRAINDICATIONS
PERSERIS should not be administered to patients with known
hypersensitivity to risperidone, paliperidone, or other components
of PERSERIS.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke in Elderly
Patients with Dementia-Related Psychosis: Increased risk of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack), including fatalities. PERSERIS is not approved for use in
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): Manage with immediate
discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue treatment if clinically
appropriate.
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and
weight gain.
Hyperprolactinemia: Prolactin elevations occur and persist
during chronic administration. Long-standing hyperprolactinemia,
when associated with hypogonadism, may lead to decreased bone
density in females and males.
Orthostatic Hypotension: Monitor heart rate and blood pressure
and warn patients with known cardiovascular disease or
cerebrovascular disease, and risk of dehydration or syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete
blood counts (CBC) in patients with a history of a clinically
significant low white blood cell count (WBC) or history of
leukopenia or neutropenia. Consider discontinuing PERSERIS if a
clinically significant decline in WBC occurs in absence of other
causative factors.
Potential for Cognitive and Motor Impairment: Use caution when
operating machinery.
Seizures: Use caution in patients with a history of seizures or
with conditions that lower the seizure threshold.
ADVERSE REACTIONS
The most common adverse reactions in clinical trials (>= 5%
and greater than twice placebo) were increased weight,
sedation/somnolence and musculoskeletal pain. The most common
injection site reactions (>= 5%) were injection site pain and
erythema (reddening of the skin).
For more information about PERSERIS, the full Prescribing
Information including BOXED WARNING, and Medication Guide visit
www.perseris.com.
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END
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