Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion
• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities.
• The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake.
• This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.
Avadel Wins Federal Circuit Appeal: Path Cleared for LUMRYZ Development in Idiopathic Hypersomnia
• The U.S. Court of Appeals for the Federal Circuit has overturned key portions of a Delaware Court injunction, allowing Avadel Pharmaceuticals to seek FDA approval for LUMRYZ in idiopathic hypersomnia.
• The ruling permits Avadel to initiate new clinical trials, offer open-label extensions, and pursue development of LUMRYZ for indications beyond narcolepsy, with patient enrollment in the Phase 3 REVITALYZ trial on track for completion by end of 2025.
• LUMRYZ, the first and only once-at-bedtime oxybate treatment for narcolepsy, received FDA approval for adults in May 2023 and for pediatric patients 7 years and older in October 2024, with 7 years of Orphan Drug Exclusivity.
Avadel Pharmaceuticals Announces Strong LUMRYZ Growth and Outlines 2025 Priorities
• Avadel Pharmaceuticals reports a significant increase in LUMRYZ revenue, with Q4 2024 sales estimated at $50 million, a 150% increase from Q4 2023.
• The company's commercial strategy focuses on enhancing the LUMRYZ experience for patients and providers to drive uptake across narcolepsy patient segments.
• For 2025, Avadel projects LUMRYZ net product revenue between $240 and $260 million, representing a 50% year-over-year growth.
• A Phase 3 trial evaluating LUMRYZ in idiopathic hypersomnia is ongoing, with completion expected in the second half of 2025.
LUMRYZ Maintains Market Exclusivity as Court Upholds FDA Approval in Narcolepsy Treatment
• A U.S. District Court has affirmed the FDA's approval of Avadel Pharmaceuticals' LUMRYZ for treating cataplexy and excessive daytime sleepiness in adults with narcolepsy.
• The court ruling supports the FDA's determination of LUMRYZ's clinical superiority over twice-nightly oxybate products, reinforcing its unique once-at-bedtime dosing schedule.
• This decision allows LUMRYZ to retain its Orphan Drug Exclusivity, ensuring its continued availability and commercial expansion within the narcolepsy community.
• LUMRYZ is the first and only once-at-bedtime oxybate treatment approved for both adult and pediatric narcolepsy patients aged 7 years and older.
Avadel's LUMRYZ Maintains Market Exclusivity as Court Upholds FDA Approval
• A U.S. District Court has affirmed the FDA's approval of Avadel Pharmaceuticals' LUMRYZ, a once-at-bedtime treatment for narcolepsy, in response to a challenge by Jazz Pharmaceuticals.
• The court ruling supports the FDA's determination of LUMRYZ's clinical superiority over twice-nightly oxybate products, reinforcing its Orphan Drug Exclusivity.
• LUMRYZ is approved for both adult and pediatric patients (7 years and older) with narcolepsy, targeting cataplexy and excessive daytime sleepiness (EDS).
• Avadel Pharmaceuticals can continue its commercial launch of LUMRYZ, expanding its reach within the narcolepsy community, now with bolstered market protection.
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