Puma Biotechnology, Inc. PBYI and Medison Pharma Ltd — Israel's leading commercial partner for innovative pharmaceuticals — entered into an exclusive agreement to commercialize Puma’sbreast cancer drug Nerlynx (neratinib) in Israel.
Nerlynx received an FDA approval in July 2017 for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer, who have been previously treated with Roche's RHHBY Herceptin-based adjuvant therapy. Notably, Nerlynx is the first anti-HER2 treatment to be approved by an extended adjuvant therapy for the indication. It is marketed in the United States in the form of tablets. It is currently not approved for commercialization outside of the United States.
Per the deal, Medison will be responsible for the necessary regulatory approval of Nerlynx in Israel and once approved for commercializing it in Israel. The company plans to file for a marketing authorization for Nerlynx with the Ministry of Health of Israel, and expects to receive regulatory approval during the first half of 2019. On the other hand, Puma will receive upfront and milestone payments and double digit royalties on Nerlynx sales in the region.
However, Puma’s shares have significantly outperformed the industry over a year. The stock has rallied 102.9% compared with the industry’s 7.9% growth.
However, we remind investors that recently, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency met with Puma to convey that the former will most probably vote against the approval of neratinib at the formal CHMP decision vote scheduled next month. According to CHMP, the benefit risk assessment is unfavorable because the study results are based on evidence from a single pivotal trial.
The company might need to take additional steps to get approval in Europe.
Zacks Rank & Key Picks
Puma carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the health care space are XOMA Corporation XOMA and Exelixis, Inc. EXEL. While XOMA sports a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company has skyrocketed 678.3% over a year.
Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average of 572.92%. Share price of the company has surged 68.4% over a year.
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