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STA readies breast cancer drug for PBAC
Posted 23 November 2017
Early-stage breast cancer therapy Nerlynx (neratinib) is in filing processes for ARTG registration with a PBAC submission not far behind, the drug's licensee Specialised Therapeutics Asia (STA) has said.
"We have already initiated the regulatory submission process here in Australia, and as a result will be submitting to the PBAC utilising the parallel application process," CEO Carlo Montagner said.
Nerlynx was licensed to STA from US biopharmaceutical company Puma, which received FDA approval for the drug in July as an adjuvant treatment for women with early-stage HER2+ breast cancer following initial adjuvant chemotherapy and trastuzumab-based (Roche's Herceptin) treatment.
STA will market the drug in the Asia-Pacific region, including Australia, New Zealand, Singapore and Malaysia.
It said in a statement that it would not disclose the commercial terms of the agreement, "but Puma will receive an upfront payment as well as milestones and other payments on Nerlynx sales in all STA regions".
The drug's submission to the TGA will include results from a phase 3 study showing it reduced risk of invasive disease occurrence and death in breast cancer patients by 27 per cent compared to placebo, while the hormone receptor positive subset of patients registered a greater reduction of 40 per cent in the endpoints.
Its US approval marked it as the first drug available for the extended adjuvant setting (meaning treatment of patients after initial adjuvant therapy following surgery) with STA and Puma hoping the drug could also fill that gap in the Australian landscape.
"Despite the clear proven benefit of standard of care chemotherapy and trastuzumab therapy, one in four women diagnosed with early-stage hormone receptor positive breast cancer can still have a relapse within five years," lead investigator of the trial Arlene Chan said.
"This drug will now prevent some of those women from experiencing that recurrence."
Nerlynx is not the only cancer drug STA is trying to bring to Australia. The company has also inked licensing deals with Spanish company Pharma Mar to market two late stage candidates, Aplidin (plitidepsin) in multiple myeloma and lurbinectedin in ovarian cancer, while beefing up its regional presence, saying it intends to appoint a new general manager and more staff to its Singapore headquarters.
Aplidin was submitted to the EMA for marking approval last December.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 23 November 2017
Early-stage breast cancer therapy Nerlynx (neratinib) is in filing processes for ARTG registration with a PBAC submission not far behind, the drug's licensee Specialised Therapeutics Asia (STA) has said.
"We have already initiated the regulatory submission process here in Australia, and as a result will be submitting to the PBAC utilising the parallel application process," CEO Carlo Montagner said.
Nerlynx was licensed to STA from US biopharmaceutical company Puma, which received FDA approval for the drug in July as an adjuvant treatment for women with early-stage HER2+ breast cancer following initial adjuvant chemotherapy and trastuzumab-based (Roche's Herceptin) treatment.
STA will market the drug in the Asia-Pacific region, including Australia, New Zealand, Singapore and Malaysia.
It said in a statement that it would not disclose the commercial terms of the agreement, "but Puma will receive an upfront payment as well as milestones and other payments on Nerlynx sales in all STA regions".
The drug's submission to the TGA will include results from a phase 3 study showing it reduced risk of invasive disease occurrence and death in breast cancer patients by 27 per cent compared to placebo, while the hormone receptor positive subset of patients registered a greater reduction of 40 per cent in the endpoints.
Its US approval marked it as the first drug available for the extended adjuvant setting (meaning treatment of patients after initial adjuvant therapy following surgery) with STA and Puma hoping the drug could also fill that gap in the Australian landscape.
"Despite the clear proven benefit of standard of care chemotherapy and trastuzumab therapy, one in four women diagnosed with early-stage hormone receptor positive breast cancer can still have a relapse within five years," lead investigator of the trial Arlene Chan said.
"This drug will now prevent some of those women from experiencing that recurrence."
Nerlynx is not the only cancer drug STA is trying to bring to Australia. The company has also inked licensing deals with Spanish company Pharma Mar to market two late stage candidates, Aplidin (plitidepsin) in multiple myeloma and lurbinectedin in ovarian cancer, while beefing up its regional presence, saying it intends to appoint a new general manager and more staff to its Singapore headquarters.
Aplidin was submitted to the EMA for marking approval last December.
Yajun Ma
yajun.ma@lushmedia.com.au
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