Jazz Pharmaceuticals gets FDA nod for new indication of Vyxeos

Zacks Equity Research - 8/13/2021

Jazz Pharmaceuticals plc JAZZ announced that the FDA has granted approval to label expansion of its leukemia drug, Vyxeos, in pediatric patients aged one to 21 years. The drug is now approved to treat adult as well as paediatric patients with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

The label expansion of the drug was supported by data from two single-arm clinical studies conducted separately by Children's Oncology Group and Cincinnati Children's Hospital as well as data on effectiveness of Vyxeos from previously completed clinical studies in adult patients.

The drug generated $121.1 million in sales in 2020, almost flat yearoveryear. The label expansion of the drug will likely bring additional revenues.Jazz is also evaluating Vyxeos in other AML patient populations, such as adults with standard or intermediate-risk AML, in combination with targeted AML treatments and in new inidcations (myelodysplastic syndromes, or MDS).

Shares of Jazz have gained 0.9% so far this year against the industry’s decrease of 3.5%

Apart from Vyxeos, the company has three other approved oncology drugs — Defitelio, Zepzelca and Erwinaze — in its portfolio. Although Zepzelca was approved in June 2020 as a treatment for relapsed small cell lung cancer, the drug has shown promising uptake. The drug is likely to boost the company’s oncology revenues significantly in 2021.

Meanwhile, the company is also seeking approval for its novel asparaginase, JZP-458, as potential treatment for acute lymphoblastic leukemia or lymphoblastic lymphoma.The company expects to launch JZP-458 in mid-2021, following a potential approval.

Please note that Jazz generates the majority of its revenues from its sleep franchise led by Xyrem. Meanwhile, the FDA approved Xywav, a low sodium formulation of Xyrem, in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. Xywav recorded sales of $15.3 million in 2020. At the end of 2020, Jazz had approximately 1,900 active Xywav patients. The low sodium content of the same boosts its potential as it can cater to a greater number of patients compared to Xyrem.

We note that Jazz is intheprocess of diversifying its portfolio of drugs following the completion of acquisition of British cannabinoid drug company, GW Pharmaceuticals GWPH. The acquisition will add GW Pharmaceuticals’ lead oral solution, Epidiolex, approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The acquisition thus adds a third high-growth commercial franchise to Jazz’s business.

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