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Jazz's (JAZZ) Leukemia Drug Vyxeos Gets Approval in Europe

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Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the marketing authorization application ("MAA") for its leukemia drug, Vyxeos received approval in Europe. The drug is approved for the treatment of newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adult patients.

The drug was approved in the United States for similar indications in August 2017. It generated sales of $54.2 million in the first six months of 2018. However, the company has lowered full-year revenue guidance for the drug as it performed below company’s expectations. The company will launch the drug country-by-country as and when pricing and reimbursement decisions are made. The impact of this approval on drug’s sales remains to be seen.

Jazz’s shares have returned 24.4% so far this year, outperforming the industry’s gain of mere 0.9%.

The MAA included data from five clinical studies, including a pivotal phase III study, which compared Vyxeos (cytarabine and daunorubicin liposome injection) to the current standard-of-care (7+3 chemotherapy regimen). The drug achieved a median overall survival of 9.6 months versus 5.9 months for standard of care. Vyxeos also achieved superiority in complete response rate.

Acute myeloid leukemia is progressive and a life-threatening blood cancer, which originates in bone marrow and spreads to other parts of the body through blood. Moreover, t-AML and AML-MRC have poor prognosis compared to other forms of leukemia and have limited treatment options available. Thus, there is significant unmet need in the targeted area.

Zacks Rank & Stocks to Consider

Jazz currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Endo International plc , BioSpecifics Technologies Corp and Pacira Pharmaceuticals, Inc. (PCRX - Free Report) . All the stocks sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo’s earnings per share estimates have increased from $2.39 to $2.60 for 2018 and from $2.54 to $2.69 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 29.11%. The stock has rallied 100.6% so far this year.

BioSpecifics’ earnings per share estimates have increased from $2.09 to $2.28 for 2018 and from $2.13 to $2.38 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 11.37%. The stock has rallied 19.5% so far this year.

Pacira’s earnings per share estimates have increased from 28 cents to 52 cents for 2018 and from $1.05 to $1.08 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 172.92%. The stock has increased 1.2% so far this year.

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