New licensing deal for Specialised Therapeutics

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A new licensing deal for Specialised Therapeutics Asia (ST Asia) wth the company acquiring rights to a breast cancer medicine shown to reduce the risk of recurrence.

Under the terms of the arrangement with US biopharmaceutical company Puma Biotechnology, Specialised Therapeutics will market the drug NERLYNX (neratinib) throughout the Asia-Pacific, beginning with Australia, Singapore, Malaysia and Brunei.

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

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.

According to the company, results from a double blind, placebo-controlled, randomised Phase 3 study showed NERLYNX reduces the risk of invasive disease recurrence or death by 27 per cent compared to placebo after a median follow up of 5.2 years. 

The study found that, at five years, treatment with NERLYNX resulted in a 40 per cent reduction of risk of invasive disease recurrence or death versus placebo.

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 care chemotherapy and trastuzumab therapy, one in four women diagnosed with early-stage HER2+ breast cancer can still have a relapse within five years.

“This drug will now prevent some of those women from experiencing that recurrence.

“My hope and expectation is that with longer follow up, not only will recurrence rates be reduced, but they will show that the use of NERLYNX will improve overall survival.”

Specialised Therapeutics CEO Carlo Montagner said NERLYNX was a valuable inclusion to the company’s expanding oncology portfolio.

“We are thrilled to be able to provide this therapy to women in our regions, working in collaboration with our new international partner, Puma Biotechnology,” he said.

“We plan to expedite access to this important medicine, with a Special Access Program to open in Australia in Q1 2018. This will provide early subsidised access for appropriate patients. In tandem, we will file for TGA registration and seek regulatory approval to market in other regions, including Singapore, Brunei, Malaysia and New Zealand.”

NERLYNX is an oral medication taken after chemotherapy and after 12 months of treatment with a trastuzumab-based therapy.