Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the European Commission approved its new sleep drug, Sunosi (solriamfetol). The drug will be available in Europe as a treatment to improve wakefulness and reduce excessive daytime sleepiness (“EDS”) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (“OSA”), whose EDS has not been satisfactorily treated by primary OSA therapy.
The approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had recommended the drug’s approval in November 2019. Notably, Sunosi was approved by the FDA in March 2019 to improve wakefulness and reduce EDS in adult patients with narcolepsy or OSA.
With this approval, Sunosi becomes the first drug in Europe to treat EDS in adults living with OSA. Once daily two doses of Sunosi — 75 mg and 150 mg — is approved for narcolepsy patients while it will be available in three once daily doses — 37.5 mg, 75 mg and 150 mg — for OSA patients.
The marketing authorization for Sunosi in Europe was based on positive data from four clinical studies, including the TONES study, which demonstrated the superiority of Sunosi over placebo.
Jazz’s shares have gained 17% in the past year against the industry’s decrease of 0.3%.
We note that the company has developed Sunosi in an indication similar to its key marketed drug, Xyrem. Jazz is also developing another candidate, JZP-258, a low sodium formulation and a Xyrem follow-on product, in late-stage studies for EDS and cataplexy in narcolepsy patients.
Xyrem sales grew significantly in 2018 and totaled $1.4 billion. In 2018, the drug generated almost 75% of Jazz’s total revenues. The company expects Xyrem’s sales to be in the range of $1.6-$1.64 billion in 2019. It is expected to report its fourth quarter earnings result next month. However, several patents protecting the drug are nearing expiration, starting December 2019. Moreover, an authorized generic version of the drug is likely to hit the markets as early as 2023.
The approval for Sunosi strengthened Jazz’s sleep disorder portfolio and is expected to help the company to offset a potential decline in Xyrem sales following a generic launch. Successful development of JZP-258 and its potential approval will be an additional boost for the company.
Approved drugs for narcolepsy include Teva Pharma’s (TEVA - Free Report) Provigil and Novartis’ (NVS - Free Report) Ritalin-SR. Some other pharma/biotech companies are developing treatments for narcolepsy. Avadel Pharmaceuticals plc (AVDL - Free Report) is one of them.
Jazz currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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