Auckland-based drug maker AFT Pharmaceuticals had signed a licence and distribution agreement with a large US pharmaceutical distributor for the commercialisation of its Maxigesic pain killer.
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Hikma Pharmaceuticals, the third biggest distributor in the US, will have exclusive rights to sell and distribute the intravenous, opioid-free post-operative pain relief medicine, in the United States.
It is AFT's first licensing agreement for the Maxigesic products in the US market. AFT is still waiting for approval for the tablet and liquid forms of the medication.
AFT managing director Dr Hartley Atkinson said it was a significant step forward for the company.
"We are excited to be entering into the US market with Hikma, which has a strong and respected US hospital market presence and ... is focused on providing cost-effective therapies which improve patient care."
AFT will get upfront, regulatory and commercial milestone payments of up to $US18.8 million (approx $NZ26.1m) as well as a share of the profit from sales.
Hartley said the deal offered a major market opportunity in the massive US market.
"The US market for post-operative pain management medication, according to independent research, was worth $US745m in 2019 and is set to grow to $US1.7 billion by 2028."
Hartley said the delay in getting the deal across the line had been the main reason for the company downgrading its earnings forecast last month.
"Had we achieved our plans to conclude the agreement with Hikma before 31 March 2021, we would have delivered FY21 (financial year) earnings in the range of guidance ... for an operating profit of $14m to $18m."
AFT now expects earnings of between $9m and $11m.