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™ (risperidone) in Canada.
HLS is a specialty pharmaceutical company focused on acquiring and commercializing latestage products for the Canadian market. Commercially, if approved, PERSERISTM would be complementary to HLS’ product Clozaril® (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® Support and Assistance Network (“CSAN®”) that includes value-added treatment provider and patient services to support Clozaril®. PERSERIS, if approved, could benefit from the CSAN® 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 cooccurring 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.
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207-353-4200
Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com
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