Puma Biotechnology Inc. (PBYI - Free Report) announced that the European Commission has given a marketing approval to its kinase inhibitor Nerlynx (neratinib). The drug has been approved as an extended adjuvant treatment of early stage hormone receptor positive (HER2-positive) breast cancer in patients, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy.
This nod was expected as in June, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing approval for Nerlynx in Europe. The product was approved for the same indication in the United States last July.
Puma plans to commercialize Nerlynx in Europe in 2019, starting with a launch in Germany during the first half of 2019 followed by other European countries in the second half of 2019.
Shares of Puma were marginally up following the news on Wednesday. However, the stock has plummeted 54.5% year to date, significantly wider than the industry’s decrease of 2.8%.
The approval in the EU was based on the positive results from a double-blind, placebo-controlled phase III ExteNET study. Data from the trial showed that after a couple of years of follow-up, the invasive disease-free survival (iDFS) was 95.3% in the subjects, who received Nerlynx within a year after the completion of Herceptin based adjuvant therapy compared with 90.8% in those having dosed with placebo.
Notably, breast cancer is the most common form of cancer diagnosed in women with 20-25% patients affeced with/suffering HER2-positive. Although Herceptin reduces the risk of recurrence regarding early stage HER2-positive breast cancer post-surgery, a quarter of patient experiences relapse. Nerlynx seems an ideal treatment option for such patients.
Sales of Nerlynx have improved steadily since its launch last July. The drug generated sales of $86.8 million in the first half of 2018. Following this approval by the European regulatory body, Puma expects to pick up sales during 2019.
Also, in the first quarter of 2018, the National Comprehensive Cancer Network (NCCN) guidelines were updated to include Nerlynx as a recommended combination treatment option for breast cancer patients with brain metastases. Most physicians use the NCCN parameters to determine the best course of regimen for their cancer patients.
Several additional studies on Nerlynx targeting different types of breast cancer patient populations and in earlier-line settings are currently underway. Meanwhile, several phase II combination studies on Nerlynx for breast cancer are ongoing. Notably, Puma expects to present data from the phase III NALA study, evaluating Nerlynx in third-line HER2-positive metastatic breast cancer in the second half of 2018 or first half of 2019.
Zacks Rank & Stocks to Consider
Puma Biotech currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are Gilead Sciences, Inc. (GILD - Free Report) and Illumina, Inc. (ILMN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead Sciences’ earnings estimates have been moved 7.7% north for 2018 and 1.9% for 2019 over the past 60 days. The stock has gained 4% year to date.
Illumina’s earnings estimates have been revised 12.1% upward for 2018 and 10% for 2019 over the past 60 days. The stock has risen 58.5% so far this year.
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