Pharma Focus Asia

Puma Biotechnology and Specialised Therapeutics Asia Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib)

Thursday, November 23, 2017

Puma Biotechnology, Inc., a biopharmaceutical company, and Specialised Therapeutics Asia, an international biopharmaceutical company with strategic focus and expertise in Australia, New Zealand and South East Asia, have entered into an exclusive agreement under which Specialised Therapeutics will commercialize NERLYNX® (neratinib) throughout South East Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand. Currently, Specialised Therapeutics markets Abraxane® and other oncology products in these countries.

NERLYNX is not approved currently for commercialization outside of the United States. Specialised Therapeutics will be responsible for seeking the requisite regulatory approvals and, once approved, for commercializing NERLYNX in those countries. Puma will receive upfront and milestone payments of up to $4.5 million throughout the term of this agreement, as well as significant double digit royalties on NERLYNX sales in all regions in which Specialised Therapeutics commercializes NERLYNX.

“Our new agreement with Specialised Therapeutics demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market,” stated Alan H. Auerbach, Chief Executive Officer and President of Puma. “We are confident this new partnership will help patients in our new partner’s regions access NERLYNX at the earliest opportunity.”

“We are thrilled to be selected as Puma’s first international partner able to provide this therapy to women in our region. We plan to expedite access to this important therapy with a Special Access Program, which we expect to open in Australia in the first quarter of 2018. In tandem, we plan to file for Therapeutic Goods Administration (TGA) registration and to seek regulatory approval to market in other countries, including Singapore, Malaysia, Brunei and New Zealand,” said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. “We expect to have regulatory approval for NERLYNX in Australia by the second quarter of 2019.”

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2 positive breast cancer following adjuvant trastuzumab based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets.

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