Restructuring to Reduce R&D Workforce by 75%
Focus on Capital Savings for Rollontis Commercialization
[Asia Economy Reporter Lee Gwan-joo] Spectrum Pharmaceuticals, the U.S. partner of Hanmi Pharmaceutical, announced that it will focus on the neutropenia treatment drug Rolontis (U.S. name Rolvedon), which has already received approval, following the U.S. approval hold on Hanmi’s non-small cell lung cancer treatment new drug 'Poziotinib.' This is interpreted as a move to effectively halt the development of Poziotinib.
On the 25th, Spectrum stated that it would immediately lower the priority of the Poziotinib project and concentrate company resources on the marketing and sales of Rolontis, which has obtained U.S. Food and Drug Administration (FDA) marketing approval. Spectrum plans to carry out restructuring, including a 75% reduction in research and development (R&D) personnel by the end of the year, and invest the saved operating capital into the commercialization costs of Rolontis.
Spectrum received a Complete Response Letter (CRL) from the FDA the day before, stating "At this time, Poziotinib cannot be approved." Earlier, concerns grew that approval might be denied after the FDA Oncology Drug Advisory Committee (ODAC) gave a negative recommendation on Poziotinib in September, but for now, approval has been put on hold with the receipt of the CRL.
A CRL is a formal communication sent by the FDA after a comprehensive review of a New Drug Application (NDA) when additional actions are required. In other words, it indicates that immediate approval is unlikely, but the applicant can supplement the relevant information and request a re-examination. Rolontis, which actually obtained FDA marketing approval, also received a CRL last year. At that time, the FDA delayed approval due to the need for additional information related to production inspections.
However, unlike Rolontis, questions were raised about the efficacy of Poziotinib. In September, the FDA Oncology Drug Advisory Committee (ODAC) voted 9 to 4 that "the benefits of Poziotinib do not outweigh the risks." ODAC is an independent advisory committee composed of experts who review and evaluate data on the efficacy and safety of oncology drugs. ODAC expressed strong concerns about Poziotinib’s efficacy, stating, "If granted accelerated approval, this would be the least effective targeted therapy for lung cancer approved to date."
In this situation, Spectrum appears to have concluded that focusing on the market entry of Rolontis, which has already been approved, is the best course of action rather than continuing the development of Poziotinib. This effectively amounts to a declaration of the discontinuation of Poziotinib’s development.
Tom Lee, President of Spectrum, said, "It is a difficult decision, but we believe this approach aligns with the best interests of Spectrum and our shareholders," adding, "We will do our best to explore future strategic alternatives for Poziotinib." He also expressed sincere gratitude to the patients, families, and clinicians who dedicated themselves to the Poziotinib program.
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