AFT Pharmaceuticals (ASX.AFP) has signed an exclusive License and Distribution Agreement with Hikma Pharmaceuticals USA for the commercialisation of its Maxigesic IV, an intravenous, opioid free post-operative pain relief medicine, in the United States.
Managing Director, Dr Hartley Atkinson, said 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.
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,” Dr Atkinson said.
“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 2028.2
“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.
Maxigesic IV offers clinicians and healthcare providers a strong proposition. It is an effective alternative for the treatment of post-operative pain. It also avoids the side effects of traditional opioid-based analgesics that have fuelled an unprecedented cycle of addiction and abuse around the world.
The US agreement adds to existing Maxigesic IV agreements in Europe: Everpharm [Germany, Austria, France, and Italy]; Aguettant [Nordics, Netherlands, Portugal, and Spain]; Medochemie [Bulgaria, Cyprus, Czech Republic, Hungary, Romania, and Slovakia], Jed Pharma [Ireland] and Edge [United Kingdom], Vianex [Greece].
Outside Europe, AFT has also negotiated licensing agreements for Maxigesic IV in Ecuador [Acino], Hong Kong [DKSH] and Thailand [Alliance Pharma]. All of the agreements have been negotiated over the past year in spite of COVID-19 travel bans and are among the many steps AFT has taken to set itself up for continued growth,