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Puma, CANbridge Team Up to Commercialize Nerlynx in China

Zacks Equity Research

Puma Biotechnology, Inc. PBYI entered into an exclusive agreementwith a biopharmaceutical company, CANbridge under which the latter will develop and commercialize Nerlynx (neratinib) in mainland China, Taiwan, Hong Kong, and Macau (greater China).

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 as Nerlynx tablets. It is currently not approved for commercialization outside the United States. 

Puma’s shares have outperformed the industry so far over a year. The stock has rallied 95.8% compared with the industry’s 6% growth.



Per the deal, CANbridge will be responsible for getting the required regulatory approval and once approved, for commercializing Nerlynx in greater China. Puma will receive an upfront payment of $30 million and potential milestone payments totaling up to $40 million upon achievement of certain regulatory milestones. CANbridge expects to make Nerlynx commercially available in China by mid- 2019. Further, Puma will receive significant double-digit royalties on Nerlynx sales in greater China and potential milestone payments upon the achievement of certain sales-based milestones.

Recently, Pumaand Medison Pharma Ltd — Israel's leading commercial partner for innovative pharmaceuticals — entered into an exclusive agreement to commercialize Puma’s breast cancer drug Nerlynx (neratinib) in Israel. 

However, we remind investors that in January 2018, 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.


Puma Biotechnology Inc Price


Puma Biotechnology Inc Price | Puma Biotechnology Inc Quote


Zacks Rank & Stocks to Consider

Puma carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the health care space are XOMA Corporation XOMA and Exelixis 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 pulled off 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 624.9% over a year.

Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 in the last 60 days. The company delivered positive earnings surprise in the last four quarters, with an average beat of 572.92%. Share price of the company has surged 64.1% over a year.

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