Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM

Rhea-AI Summary

Teva Pharmaceuticals, in collaboration with MedinCell, received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application for TV-46000/mdc-IRM, an injectable treatment for schizophrenia. This letter indicates that the application cannot be approved in its current form. Teva aims to work with the FDA to address feedback and remains dedicated to developing this treatment. The application was based on Phase 3 data from two pivotal studies assessing the drug's efficacy and safety.

Positive

• Commitment to the development of risperidone for schizophrenia treatment.
• Plans to work closely with the FDA to address recommendations.

Negative

• Received a Complete Response Letter from the FDA, indicating issues with the New Drug Application for TV-46000/mdc-IRM.
• Delay in the approval process for the schizophrenia treatment.

PARSIPPANY, N.J. & TEL AVIV, Israel & PARIS--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.

Teva and Medincell remain committed to the development of risperidone and to providing patients with access to the product in the U.S., as quickly as possible. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations.

The application included Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

About MedinCell

MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities. www.medincell.com

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 regarding TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use), 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 develop TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use); our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220419006090/en/

Teva IR Contacts

United States

Ran Meir 267-638-8167

Yael Ashman 972 (3) 914-8262

Teva PR Contacts

United States

Kelley Dougherty 973-832-2810

Yonatan Beker 973-917-0851

MedinCell

France

David Heuzé (Head of Communication) +33 (0) 6 83 25 21 86 david.heuze@medincell.com

Louis-Victor Delouvrier (NewCap – IR) +33 (0) 1 44 71 98 53 medincell@newcap.eu

Nicolas Merigeau (NewCap - Media Relations) +33 (0) 1 44 71 94 98 medincell@newcap.eu

Source: Teva Pharmaceutical Industries Limited

FAQ

What is the Complete Response Letter received by Teva regarding TV-46000?

The Complete Response Letter indicates that the FDA cannot approve Teva's application for TV-46000 in its current form and requires further information.

What are the implications of the FDA's decision on Teva's stock?

The FDA's Complete Response Letter may negatively impact Teva's stock by delaying potential revenue from the new treatment.

When was the FDA Complete Response Letter issued to Teva for TV-46000?

The Complete Response Letter was announced recently, but the exact date is not specified in the press release.

What is Teva's plan following the Complete Response Letter from the FDA?

Teva plans to review the letter's contents and collaborate with the FDA to address the recommendations outlined.

What studies were included in Teva's application for TV-46000?

The application included data from the RISE Study and SHINE Study, which evaluated the efficacy and safety of TV-46000 for schizophrenia.