Specialised Therapeutics to commercialise Puma’s Nerlynx for breast cancer

Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage human epidermal growth factor receptor 2 (HER2) overexpressed / amplified breast cancer.

The treatment follows adjuvant trastuzumab-based therapy.

Nerlynx is not currently approved for commercialisation outside of the US.

Under the deal, Specialised Therapeutics will have the right to commercialise the treatment across South East Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand.

The company will be responsible for seeking the necessary regulatory approvals and, once approved, it will commercialise the product in these countries.

Throughout the agreement period, Puma Biotechnology will receive upfront and milestone payments of up to $4.5m and double-digit royalties on the sale of Nerlynx in all regions where Specialised Therapeutics commercialises the treatment.

Specialised Therapeutics CEO Carlo Montagner said: “We plan to expedite access to this important therapy with a Special Access Programme, 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.

“We expect to have regulatory approval for Nerlynx in Australia by the second quarter of 2019.”

In July this year, Neratinib was approved by the US Food and Drug Administration (FDA) and is marketed in the country as Nerlynx tablets.

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