December 15, 2017

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New Early- Breast Cancer Drug to be Made Available in Australia, New Zealand and South East Asia Following License Deal

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SINGAPORE and MELBOURNE, Australia, Nov. 22, 2017 /PRNewswire/ — A NEW breast cancer drug shown to reduce the risk of cancer recurrence will soon be made available in Australia, New Zealand and throughout South-East Asia, following a key license deal between Specialised Therapeutics Asia (ST Asia) and US biopharmaceutical company Puma Biotechnology, Inc. (NASDAQ: PBYI).

Under the terms of the exclusive arrangement, Specialised Therapeutics will market the drug NERLYNX® (neratinib) throughout the Asia-Pacific, beginning with Australia, Singapore, Malaysia and Brunei.

It will be available to women with early-stage, HER2+ breast cancer following standard of care adjuvant chemotherapy and 12 months of trastuzumab-based therapy.

Commercial terms of the agreement are not being disclosed, but Puma will receive an upfront payment as well as milestones and other payments on NERLYNX sales in all ST Asia regions.

NERLYNX is the first treatment to be FDA approved for extended adjuvant therapy in early-stage HER2+ breast cancer following adjuvant trastuzumab-based therapy.

Results from a double blind, placebo-controlled, randomised Phase 3 study showed that NERLYNX reduces the risk of invasive disease recurrence or death by 27% compared to placebo after a median follow up of 5.2 years. The 5-year invasive disease-free survival (iDFS) rate for the NERLYNX arm was 90.2% compared to 87.7% in the placebo arm (p=0.008).1

For the pre-defined subgroup of patients with hormone receptor positive disease, approximately 57% of the overall study population, the results of the trial demonstrated that at 5 years, treatment with neratinib resulted in a 40% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.60, p = 0.002 ).3  In this sub-group, the 5-year iDFS rate for the neratinib arm was 91.2% compared to 86.8% in the placebo arm. 1

The safety results showed the most frequently observed adverse event for the NERLYNX-treated patients was diarrhoea, with approximately 40% of the NERLYNX-treated patients experiencing grade 3 or higher diarrhoea (1 patient (<1%) had grade 4 diarrhoea). Patients who received NERLYNX in this trial did not receive any prophylaxis with anti-diarrhoeal agents.1,2 

Principal trial investigator, Professor Arlene Chan, said the availability of NERLYNX in Australia and other regions was an important step forward in further reducing recurrence in HER2+ early breast cancer.

“This is a drug that provides a potential cure for some women who may otherwise have had a recurrence,” she said.

“Despite the clear proven benefit of standard of

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