PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Files An 8-K Entry into a Material Definitive Agreement

PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.

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On January30, 2018, Puma Biotechnology, Inc. (the “Company”) entered into an exclusive license agreement (the “Agreement”) with CANbridgepharma Limited (“CANbridge”).

to the Agreement, the Company granted to CANbridge, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license to develop and commercialize any pharmaceutical product containing neratinib (the “Licensed Product”) for the treatment of human disease (the “Field”) in the People’s Republic of China (the “Territory”), including mainland China, Hong Kong, Macao, and Taiwan (each, a “Region”).

The Agreement sets forth the parties’ respective obligations with respect to the development, commercialization and supply of the Licensed Product. CANbridge will, at its expense, develop the Licensed Product for the purpose of obtaining regulatory approval in the Field and in the Territory, subject to the Company’s approval of certain aspects of clinical studies conducted by CANbridge. Within the Territory, CANbridge will be solely responsible, at its expense, for regulatory and commercialization activities. The Company will be solely responsible, subject to certain exceptions, for the manufacturing and supply of the Licensed Product under a supply agreement that will be entered into between the parties.

to the Agreement, the Company will receive an upfront payment of $30million and potentially receive regulatory milestone payments totaling up to $40million and sales-based milestone payments totaling up to $185 million. In addition, the Company is entitled to receive significant double-digit royalties calculated as a percentage of net sales of the Licensed Products in the Territory.

The term of the Agreement continues, on a Region-by-Region basis, until (i)the later of the expiration or abandonment of the last licensed patent covering the Licensed Product in such Region or (ii)the earlier of (x)the date upon which sales of generic versions of the Licensed Product reach a specified level in such Region, or (y)the tenth anniversary of the first commercial sale of the Licensed Product in such Region. The Agreement may be terminated by either party if the other party commits a material breach, subject to a customary cure period, or if the other party is insolvent; provided that if CANbridge materially breaches its development or commercialization obligations in a particular Region, the Company may terminate the Agreement solely with respect to such Region. CANbridge may terminate the agreement at its convenience.

The foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March31, 2018.


About PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI)

Puma Biotechnology, Inc. is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to over three drug candidates, including PB272 (neratinib (oral)), which the Company is developing for the treatment of patients with human epidermal growth factor receptor type 2 (HER2), positive breast cancer, and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of patients with advanced cancer, and PB357, which is an orally administered agent. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4.

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