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Teva Statement on European Commission Decision; Company to Appeal

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Teva Pharmaceuticals has announced its intention to appeal a European Commission decision regarding its practices related to COPAXONE®, a multiple sclerosis treatment. The company strongly disagrees with the Commission's decision, which it describes as based on extreme and untested legal theories lacking factual support.

The company has been cooperating with the EC since 2019 and states it will vigorously defend its position. Teva emphasizes its commitment to ethical business practices and continued support for MS patients, while noting it is financially prepared to mount its defense.

Teva Pharmaceuticals ha annunciato la sua intenzione di fare appello a una decisione della Commissione Europea riguardo alle sue pratiche legate a COPAXONE®, un trattamento per la sclerosi multipla. L'azienda esprime un forte disaccordo con la decisione della Commissione, che considera basata su teorie legali estreme e non testate, prive di supporto fattuale.

Sin dal 2019, l'azienda è stata in cooperazione con la CE e afferma che difenderà energicamente la sua posizione. Teva sottolinea il suo impegno per pratiche commerciali etiche e il continuo supporto per i pazienti affetti da SM, facendo notare di essere finanziariamente preparata a difendersi.

Teva Pharmaceuticals ha anunciado su intención de apelar una decisión de la Comisión Europea relacionada con sus prácticas en torno a COPAXONE®, un tratamiento para la esclerosis múltiple. La empresa no está de acuerdo en absoluto con la decisión de la Comisión, que describe como basada en teorías legales extremas y no probadas, sin apoyo fáctico.

La compañía ha estado cooperando con la CE desde 2019 y afirma que defenderá su posición con vigor. Teva enfatiza su compromiso con prácticas comerciales éticas y su continuo apoyo a los pacientes con EM, al tiempo que señala que está preparada financieramente para llevar a cabo su defensa.

테바 제약은 다발성 경화증 치료제인 COPAXONE®와 관련된 관행에 대한 유럽 위원회의 결정에 이의를 제기할 의사를 밝혔습니다. 회사는 위원회의 결정에 강하게 반대합니다, 이는 극단적이고 검증되지 않은 법리 이론에 근거하며 사실적 지원이 부족하다고 설명합니다.

회사는 2019년 이후 EC와 협력해 왔습니다고 주장하며, 자신의 입장을 강력히 방어할 것이라고 말합니다. 테바는 윤리적 비즈니스 관행에 대한 헌신과 MS 환자에 대한 지속적인 지원을 강조하며, 방어를 위한 재정적 준비가 되어 있다고 언급합니다.

Teva Pharmaceuticals a annoncé son intention de faire appel d'une décision de la Commission européenne concernant ses pratiques liées à COPAXONE®, un traitement de la sclérose en plaques. L'entreprise n'est pas du tout d'accord avec la décision de la Commission, qu'elle décrit comme étant fondée sur des théories juridiques extrêmes et non testées, sans support factuel.

La société collabore avec la CE depuis 2019 et déclare qu'elle défendra vigoureusement sa position. Teva souligne son engagement envers des pratiques commerciales éthiques et son soutien continu aux patients atteints de SP, tout en notant qu'elle est financièrement préparée à mener sa défense.

Teva Pharmaceuticals hat ihre Absicht angekündigt, gegen eine Entscheidung der Europäischen Kommission bezüglich ihrer Praktiken im Zusammenhang mit COPAXONE®, einer Behandlung für Multiple Sklerose, Berufung einzulegen. Das Unternehmen disagiert stark mit der Entscheidung der Kommission, die es als auf extremen und ungetesteten rechtlichen Theorien ohne faktuelle Unterstützung basierend beschreibt.

Das Unternehmen kooperiert seit 2019 mit der EK und erklärt, dass es seine Position energisch verteidigen wird. Teva betont sein Engagement für ethische Geschäftspraktiken und die fortdauernde Unterstützung für MS-Patienten und weist darauf hin, dass es finanziell gut vorbereitet ist, seine Verteidigung zu führen.

Positive
  • Company confirms financial readiness to handle legal defense costs
Negative
  • European Commission imposed fine and negative judgment against company
  • Potential financial impact from EC fine
  • Regulatory scrutiny over COPAXONE® practices in Europe

Insights

This European Commission decision against Teva regarding COPAXONE® represents a significant regulatory challenge. The investigation, ongoing since 2019, appears to center on potential antitrust concerns, though specific details about the fine and alleged violations aren't disclosed in the announcement. The company's strong pushback, characterizing the EC's legal theories as "extreme" and "untested," suggests substantial disagreement over the interpretation of competition law.

The appeal process in EU antitrust cases typically takes 2-3 years, during which Teva must maintain compliance while challenging the decision. The company's statement about being "well prepared financially" indicates they've likely set aside provisions for potential fines, which in EU antitrust cases can reach up to 10% of global annual revenue. This regulatory action could impact Teva's European operations and potentially influence future pricing and market access strategies for COPAXONE®.

The EC's decision poses both immediate and long-term market implications for Teva. COPAXONE®, despite facing generic competition, remains a significant revenue generator in Europe. Any regulatory constraints or fines could pressure Teva's European market position and potentially affect relationships with healthcare systems and payers. The company's strong defensive stance and immediate appeal announcement aim to reassure investors about their legal position and financial stability.

The market impact extends beyond immediate financial concerns - regulatory scrutiny could influence future pricing strategies and market access across Teva's broader portfolio. The company's emphasis on ethical standards and patient support since 1996 appears aimed at protecting brand value and stakeholder relationships during this challenge.

  • Teva Pharmaceuticals disagrees with the European Commission decision, which is based on legal theories that the company believes are extreme, untested, and factually unsupported
  • The company intends to appeal the outcome and is fully prepared to mount its defense
  • Teva has supported the MS community since 1996 and will not be distracted from providing access to this important standard-of-care treatment
  • Teva works to the highest ethical standards with all our external experts and do so in a highly regulated environment

TEL AVIV, Israel, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals Industries Ltd. (NYSE: and TASE: TEVA) is responding to the European Decision following its investigation into the company’s practices regarding COPAXONE® -- the standard-of-care treatment for multiple sclerosis – and announcing its intention to appeal the judgement and fine imposed.

The company is deeply disappointed by this decision and has been cooperating extensively with the EC since 2019. Teva disagrees with the Commission’s legal theories which are legally untested and, Teva believes, not supported by the facts. The company will vigorously defend its position on appeal and is well prepared financially to mount a defense.

Teva conducts its business lawfully and ethically and has been a strong partner to Europe, its patients, economy and healthcare systems. This misguided decision will not distract Teva from its unwavering support for patients living with MS and their families.

Media Contacts:

Kelley Dougherty (973) 832-2810

Eden Klein +972 (3) 906 2645   


FAQ

What is the European Commission's decision against Teva (TEVA) about?

The European Commission has made a decision regarding Teva's practices related to COPAXONE®, its multiple sclerosis treatment, resulting in a judgment and fine that Teva plans to appeal.

When did the European Commission begin investigating Teva (TEVA)?

According to the press release, Teva has been cooperating with the European Commission's investigation since 2019.

How is Teva (TEVA) responding to the European Commission's decision?

Teva is appealing the decision, stating it disagrees with the Commission's legal theories and will vigorously defend its position, noting it is financially prepared to mount a defense.

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