NICE has issued a positive recommendation for Arvelle Therapeutics’ cenobamate (Ontozry), for the treatment of focal-onset seizures in adults with uncontrolled epilepsy in England and Wales.
The EMA has recommended the approval of Arvelle Therapeutics’ cenobamate for the adjunctive treatment of focal onset seizures with or without secondary generalisation in adult patients with epilepsy, which have not been adequately controlled despite a history of treatment with at least two anti-seizure products.
ROME, Jan. 14, 2021 /PRNewswire/ -- Angelini Pharma, an international pharmaceutical company which is a part of the private Italian Angelini Group – and Arvelle Therapeutics, a Swiss-based biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announced that they have concluded a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics in an all cash transaction for a total aggregate valuation of up to $960 million. Following regulatory approval, $610M will be paid. Subsequently, and subject to cenobamate reaching certain revenue targets, a further $350M will be paid.
(Cambridge, Mass. and Stockholm, Sweden) – Dec. 30, 2020 - Moderna, Inc. (NASDAQ:MRNA), biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Recipharm (STO: RECI-B), a leading contract development and manufacturing organization (CDMO), today announced that they have reached an agreement to support formulation and fill-finish a part of the Moderna COVID-19 vaccine supply outside of the U.S. The activity will be performed in Recipharm’s drug product manufacturing facility located in France.
Zug, Switzerland, 26 May 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, is pleased to announce that the Company has closed the final tranche of its Series A financing round. The final tranche was triggered by the European Medicines Agency’s (EMA) recent acceptance of the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy, announced on 26 March 2020.
Zug, Switzerland, 17 August 2020 – Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, is pleased to announce a collaboration with Durbin Group (Durbin), a specialist pharmaceutical supplier, for the distribution of cenobamate through a Managed Access Program (MAP). Through the MAP patients with drug-resistant focal onset seizures, with a physician-assessed clinical need, may be eligible to receive treatment with cenobamate prior to its commercial availability.
ZUG, Switzerland, May 21, 2020 (GLOBE NEWSWIRE) -- Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announced the publication of a key trial (013 Study) in Neurology, the official journal of the American Academy of Neurology (AAN). The data presented suggest that a significantly higher proportion of adults with uncontrolled focal onset seizures were able to achieve seizure-freedom (zero seizures) (28% vs 9%; p=0.0001) during the maintenance phase when treated with adjunctive cenobamate vs placebo.1 In addition, the interim results of an ongoing phase 3 safety study of cenobamate in 1339 adults with uncontrolled focal seizures (021 Study) were published in Epilepsia, the official journal of the International League Against Epilepsy (ILAE). The interim report has shown a high retention rate of 83% at six months and, in the study, cenobamate has been shown to be generally safe and well tolerated as an adjunctive treatment.
Zug, Switzerland, 26 March 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy. Validation of the MAA confirms that the application is complete and marks the start of the assessment process.