Medincell’s partner Teva Unveils New Phase 3 Positive Results for Olanzapine LAI, and Presents Real-World Data on UZEDY® at Psych Congress 20241

04 Nov 2024 08:00 CET

Regulatory News:

Medincell (Paris:MEDCL):

TEV-‘749 / mdc-TJK - Investigational Olanzapine Long-Acting Injectable

• Teva presented positive data from the initial period of the Phase 3 SOLARIS trial evaluating Olanzapine LAI in adult patients diagnosed with schizophrenia.
• Findings demonstrate significant improvement in social functioning and quality of life across multiple validated measures from baseline to week 8.
• Data show that Medincell subcutaneous delivery technology underlying olanzapine LAI resulted in no occurrence of Post-Injection Delirium/Sedation Syndrome (PDSS) events to date.
• Richard Malamut, Chief Medical Officer of Medincell, said: “These new data are quite impactful as improvements in social functioning and quality of life would represent a substantial benefit for people living with schizophrenia and their families. This is an important addition to the positive efficacy results for the primary endpoint of the phase 3 study that were announced last May. Teva also confirmed that there are still no cases of PDSS observed. This is crucial because the risk of PDSS, along with the associated post-injection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI product.”

UZEDY^® - Risperidone Long-Acting Injectable

• Real-world analyses of UZEDY reveal high adherence rates and utilization in adults with schizophrenia who have barriers to treatment.
• Christophe Douat, CEO of Medincell, commented: “Data presented on UZEDY usage highlights the significant social vulnerability faced by many individuals with schizophrenia, emphasizing the need for innovative and effective treatments like our risperidone LAI and investigational olanzapine LAI to address this critical societal challenge.”

Extract below from Teva’s press release - November 1^st, 2024: read here the complete press release

About Olanzapine LAI Phase 3 SOLARIS

SOLARIS study Period 1 is an 8-week, randomized, double-blind, placebo-controlled trial in patients aged 18-64 years diagnosed with schizophrenia, followed by an open-label safety period of up to 48 weeks (Period 2). In the study, TEV-'749 significantly improved social functioning and quality of life by week 8 across all three doses evaluated compared to placebo in a hospitalized population. The results showed:

• The mean difference in change in the Personal and Social Performance Scale, a standard measure of social functioning, from baseline to week 8 was superior with TEV-'749 318mg (4.63), 425mg (3.15), and 531mg (4.93) versus placebo (all P<0.05). The mean difference in change to week 4 was statistically significant for TEV-'749 318mg (P<0.05) and numerically greater for all other TEV-'749 doses versus placebo.²
• Treatment with TEV-'749 significantly improved Schizophrenia Quality of Life Scores, with greater mean difference in change from baseline to week 8 observed at the 318mg (-3.99), 425mg (-5.39), and 531mg (-5.65) doses versus placebo (all P<0.05).²
• Changes from baseline to week 8 in EuroQoL-5 Dimensions-3 Levels (exploratory endpoint), another quality-of-life measure, were numerically higher at week 8 with TEV-'749 at the 425mg dose versus placebo.^2,3

As previously announced, efficacy results from the SOLARIS trial showed that by week 8, TEV-'749 met its primary endpoint across all three dosing groups, with statistically significant mean differences in the change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8 (all P<0.0001). The systemic safety profile of TEV-'749 was consistent with other approved oral formulations of olanzapine, with no new safety signals identified and no PDSS events reported to date.

About UZEDY real-world analyses

The results provide insight into real-world treatment patterns with UZEDY since its approval for the treatment of schizophrenia in adults by the U.S. Food and Drug Administration in April 2023.

Analyses of U.S. claims data from adults living with schizophrenia who received treatment with UZEDY (n=715) examined social determinants of health (SDOH) as well as patterns of adherence. Results reveal high adherence rates in adults living with schizophrenia who have unmet social needs.

• 41% of patients were covered by Medicaid, 8% had Medicare, and 40% had dual coverage.²
• Of those patients with available data on SDOH (n=189), over half had low educational attainment, lived in poverty, had experienced food insecurity, and/or had limited access to healthcare. A large minority (44% ; n=83/189) were additionally affected by housing instability.²
• 69% were adherent (defined as proportion of days covered greater than or equal to 80%).²
• A lines of therapy analysis found that use of UZEDY as a first-line treatment option was at 12%, however patients prescribed UZEDY had most commonly received oral second-generation antipsychotics as their initial therapy.²

UZEDY^® (1-month and 2-month subcutaneous risperidone for treatment of schizophrenia), is the first product based on Medincell's long-acting injection technology, BEPO^®, that reached commercial stage. US marketing authorization was obtained from the U.S. FDA on April 28, 2023, immediately followed by commercial launch by Teva in May 2023.

TEV-‘749 / mdc-TJK is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine for treatment of schizophrenia. It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of olanzapine have been associated with a FDA black box warning for PDSS that limits their use.

Medincell’s partner Teva leads the clinical development and regulatory process and is responsible for commercialization of these products. Medincell is entitled to receive royalties on net sales, along with development and commercial milestone payments.

¹ Psych Congress 2024, October 29-November 2, 2024, in Boston, MA (USA): www.hmpglobalevents.com/psych-congress
² Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
³ EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) is a standardized tool for measuring health-related quality of life. It assesses the impact of a disease or treatment on a person's quality of life across five dimensions: mobility (problems with movement), self-care (ability to wash and dress oneself), usual activities (daily tasks, work, leisure), pain/discomfort, and anxiety/depression.

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.

UZEDY^® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

medincell.com

This press release contains forward-looking statements, including statements regarding Company’s expectations for (i) the timing, progress and outcome of its clinical trials; (ii) the clinical benefits and competitive positioning of its product candidates; (iii) its ability to obtain regulatory approvals, commence commercial production and achieve market penetration and sales; (iv) its future product portfolio; (v) its future partnering arrangements; (vi) its future capital needs, capital expenditure plans and ability to obtain funding; and (vii) prospective financial matters regarding our business. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are forward-looking statements and subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", “expect”, "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", “potential”, "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance, or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (the "AMF") pursuant to its regulatory obligations, including the Company's registration document, registered with the AMF on September 4, 2018, under number I. 18-062 (the "Registration Document"), as well as in the documents and reports to be published subsequently by the Company. In particular, readers' attention is drawn to the section entitled "Facteurs de Risques" on page 26 of the Registration Document.

Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements.

This press release is for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for the Company's shares in any jurisdiction, in particular in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation, or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be subject to legal restrictions in certain jurisdictions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241103207423/en/

David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Head of US Financial Strategy & IR
grace.kim@Medincell.com / +1 (646) 991-4023

Nicolas Mérigeau/ Arthur Rouillé
Media Relations
Medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier/Alban Dufumier
Investor Relations France
Medincell@newcap.eu / +33 (0)1 44 71 94 94