Jazz Pharmaceuticals plc JAZZ and partner PharmaMar announced data from the phase III ATLANTIS study evaluating a combination regimen of their small cell lung cancer (SCLC) drug, Zepzelca (lurbinectedin). Although the study failed to meet its pre-specified criteria of significance for the primary endpoint of overall survival (OS), the company believes overall results support the activity and tolerability of the drug in metastatic SCLC.
The ATLANTIS study evaluated 2.0mg/m2 dose of Zepzelca in combination with doxorubicin versus physician's choice of topotecan or cyclophosphamide/doxorubicin/vincristine in adult SCLC patients whose disease progressed on or after platinum-based chemotherapy. Please note that Zepzelca received accelerated approval from the FDA as monotherapy for metastatic SCLC patients in similar setting earlier in June. We also note that the study evaluated a lower dose of the drug compared to 3.2mg/m2 FDA-approved dose. Moreover, the study did not evaluate Zepzelca monotherapy.
The safety profile in the ATLANTIS study was consistent with the known safety profile of Zepzelca monotherapy.
Detailed data from the study will be presented at a future medical meeting. Based on the ATLANTIS study data, Jazz plans further development of Zepzelca as monotherapy as well as in combination in SCLC and other tumors. The company will also provide the study data to the FDA and discuss with the regulatory body the confirmatory data needed for full approval of the drug as monotherapy.
Jazz entered into an exclusive license agreement with Spain-based Pharma Mar in December 2019, gaining U.S. commercialization rights to lurbinectedin. The company launched the drug in the U.S. market in July. The drug recorded sales of $36.9 million in the third quarter, representing promising launch uptake. The company had also raised its financial guidance for 2020 based on strong performance of its drugs during the third quarter and the robust launch of Zepzelca.
Several analysts are also of the view that failure to meet the primary endpoint in the ATLANTIS study is unlikely to affect Zepzelca’s accelerated approval and have minimal impact on the uptake trend for the drug as monotherapy.
Shares of Jazz were up almost 4.5% on Dec 3 following the announcement. The company’s shares have gained 36.9% since June end compared to the industry’s increase of 3.2% in the same time frame, staging a comeback after falling more than 25% in the first half of 2020.
Apart from Zepzelca, Jazz has two marketed cancer drugs in its portfolio — Erwinaze and Vyxeos. However, Jazz generates the majority of its revenues from its sleep franchise led by Xyrem. We note that 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. The low sodium content of the same boosts its potential as it can cater to a greater number of patients compared to Xyrem.
Jazz Pharmaceuticals PLC Price
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Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the same sector include Bellicum Pharmaceuticals BLCM, Ironwood Pharmaceuticals IRWD and Catalent CTLT, all carrying Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bellicum’s loss per share estimates have narrowed 73.8% for 2021 over the past 30 days.
Ironwood earnings estimates have been revised 23.7% higher for 2021 over the past 30 days.
Catalent’s earnings per share estimates have move up 5% for 2021 over the past 30 days. The stock has surged 66% year to date.
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