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JAZZ's Xywav Gets Orphan Drug Exclusivity for Hypersomnia

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Jazz Pharmaceuticals plc JAZZ announced that the FDA has granted an Orphan Drug Exclusivity (“ODE”) to its sleep medicine, Xywav oral solution, to treat adult patients with idiopathic hypersomnia (“IH”), a chronic neurological disorder characterized by excessive daytime sleepiness (“EDS”).

The FDA approved Xywav for treating adult patients with IH in August, making it the first FDA-approved medicine to treat this debilitating and unique sleep disorder. The drug will now have seven-year market exclusivity for this indication in the United States.

This marks the second ODE for Xywav, following the exclusivity granted in June 2021 for the treatment of cataplexy or EDS in narcolepsy patients aged seven years and above. Xywav was first approved for the treatment of cataplexy and EDS in narcolepsy patients aged seven years and above in July 2020.

Orphan Drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition that generally affects fewer than 200,000 individuals in the United States.

Shares of Jazz have plunged 19.3% in the past year compared with the industry’s decrease of 18.3%.

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Xywav is a low-sodium formulation of Jazz’s key sleep disorder drug, Xyrem. The low sodium content of the same boosts its potential as it can cater to a greater number of patients than Xyrem.

Xyway generated sales worth $352.6 million in the first nine months of 2021. Sales were mainly driven by patients switching from Xyrem. Jazz had approximately 6,000 active Xywav patients as of Sep 30, 2021.

With the commercial launch of Xywav for IH indication in November 2021, sales of the drug are expected to be higher in the days ahead.

Jazz’s neuroscience franchise — which consists of three sleep disorder drugs (Xyrem, Sunosi, and Xywav) and one seizure drug (Epidiolex) — is a key revenue generator for the company. In May 2021, Jazz acquired a British cannabinoid drug company, GW Pharmaceuticals. The acquisition added Epidiolex — approved for the treatment of seizures associated with two rare and severe forms of epilepsy, namely Lennox-Gastaut syndrome and Dravet syndrome — to its portfolio.

Zacks Rank & Stocks to Consider

Jazz currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Endo International plc ENDP, Infinity Pharmaceuticals, Inc. INFI and Zoetis Inc. ZTS, all sporting a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Endo International’s earnings estimates have been revised 22.8% upward for 2022 over the past 60 days.

Endo International’s earnings surpassed estimates in each of the trailing four quarters.

Infinity Pharmaceuticals’ loss per share estimates have narrowed 3.6% for 2022, over the past 60 days. The stock has rallied 21.2% in the past year.

Infinity Pharmaceuticals’ earnings surpassed estimates in one of the trailing four quarters and matched the same once while missing on the other two occasions.

Zoetis’ earnings estimates have been revised 2.8% upward for 2022 over the past 60 days. The stock has surged 42.1% in the past year.

Zoetis’ earnings have surpassed estimates in each of the trailing four quarters.


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