Wednesday 28th April 2021
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AFT Pharmaceuticals today announces it has signed an exclusive License and Distribution Agreement with Hikma Pharmaceuticals USA (“Hikma”) for the commercialisation of its Maxigesic IV, an intravenous, opioid free post-operative pain relief medicine, in the United States.
The agreement represents the first out license of the Maxigesic family of medicines into the US market. AFT, over the longer-term, is also targeting the US market for the tablet and liquid forms of the medication.
Under the terms of the license agreement, Hikma will have exclusive rights for the sales, marketing, and distribution of Maxigesic IV in the US.
In return AFT will be entitled to upfront, regulatory and commercial milestone payments of up to US$18.8 million as well as a profit share from in market product sales.
The milestone payments comprise US$7.5 million of payments due upon certain agreed milestones leading up to and including registration and the first commercial sale of Maxigesic IV in the US. Of these, US$3.6 million will be earned following the signing of the agreement and filing of Maxigesic IV for approval with the FDA. The further milestone payments are payable upon certain sales targets for Maxigesic IV in the US being reached.
AFT Managing Director Dr Hartley Atkinson said: “We are excited to be entering into the US market with Hikma, which has a strong and respected US hospital market presence and, in line with AFT’s core values, is focused on providing cost effective therapies which improve patient care.
“The US market for post-operative pain management medication, according to independent research, was worth US$745 million in 2019 and is set to grow to US$1.7 billion by 2028.
“It is satisfying to be offering a pain management medicine that gives clinicians a real alternative to opioids in the US, where addiction to these drugs has become an epidemic. We believe, with Hikma, we can capture a significant share of this revenue.”
Hikma is a global pharmaceutical company focused on complex and differentiated branded generics and generic pharmaceuticals across a broad range of indications, including respiratory, oncology and pain management.
It is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of over 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.
Dr Atkinson said AFT had expected to announce the agreement with Hikma in March this year and held that view right up to the last day of the 2021 financial year. However, as signalled at the start of this month the company had been hindered in achieving this goal due to unexpected delays in the negotiations.
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