AFT licenses Maxigesic(R) IV in the US

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN: ARBN 609 017 969





28 April 2021

AFT licenses Maxigesic
®
IV in the US
Agreement with Hikma, the US’ third largest supplier of generic injectable
medications by volume
1
, will see AFT benefit from upfront, regulatory and
commercial milestone payments worth up to US$18.8 million and a profit share from
in-market product sales.
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) 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.
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

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN: ARBN 609 017 969

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.
1


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.

“Had we achieved our plans to conclude the agreement with Hikma before 31 March
2021, we would have delivered FY21 earnings in the range of guidance affirmed in
November 2020 for an operating profit of $14 million to $18 million. Sadly, the delays
forced us to lower our guidance.

“AFT understands the importance of delivering on market expectations. We are
pleased we can now provide further colour to our last earnings update and its timing,
given the good faith efforts that we made to close out the commercially sensitive
negotiations with Hikma before the end of our financial year, and then as soon as
possible thereafter.”

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,

Meanwhile, AFT is working to complete US FDA approval for the tablet form of the
medication. In November last year, the FDA said a Good Manufacturing Practice
inspection of the tablet production facilities for Maxigesic was the “only deficiency”
with AFT’s application for regulatory approval. The inspection is still pending due to
COVID-19 related travel disruptions.

“We look forward to providing more detail when we release out audited financial
results in May.”

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN: ARBN 609 017 969


Released for and on behalf of AFT Pharmaceuticals by Chief Financial Officer
Malcolm Tubby.


Notes to editors:
Maxigesic IV (Paracetamol 1000mg + Ibuprofen 300mg solution for infusion) is a
patented intravenous formulation developed as a line extension to Maxigesic tablets,
for use post-operatively in hospitals when patients cannot take a medicine orally. A
major Phase 3 clinical trial conducted in the USA found that Maxigesic IV provided
significantly better pain relief than either paracetamol (acetaminophen) IV or
ibuprofen IV alone in the same doses.
3
Further, recently completed exposure trials
have demonstrated the drug’s efficacy and safety in an expanded population group
over a longer treatment period.
4


About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets, and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical
distribution channels: over the counter (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded, and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and in certain Southeast Asian markets, and to out-license our products to
local licensees and distributors to over 125 countries around the world. For more
information about the company, visit our website www.aftpharm.com.

About Hikma:
Hikma helps put better health within reach every day for millions of people in more
than 50 countries around the world. For more than 40 years, we've been creating high-
quality medicines and making them accessible to the people who need them.
Headquartered in the UK, we are a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and Europe, and we use
our unique insight and expertise to transform cutting-edge science into innovative
solutions that transform people's lives. We're committed to our customers, and the
people they care for, and by thinking creatively and acting practically, we provide
them with a broad range of branded and non-branded generic medicines. Together,
our 8,600 colleagues are helping to shape a healthier world that enriches all our
communities. We are a leading licensing partner, and through our venture capital
arm, are helping bring innovative health technologies to people around the
world. For more information, please visit: www.hikma.com
About Ferghana Partners (New York, London, Boston) initiated the Hikma transaction
and provided strategic/financial advisory services to AFT Pharma.

For more information:
Investors Media
Dr Hartley Atkinson Richard Inder

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN: ARBN 609 017 969

Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232


References
1. Hikma Product Press Release (2020)
2. 2020 Postoperative Pain Market Insights, Epidemiology and Market Forecast—
2028. Delveinsight.
3. Daniels, S.E, Playne, R., Stanescu, I., Zhang, J., Gottlieb, I.J, Atkinson, H.C. (2019).
Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose
combination after bunionectomy: A randomized, double-blind, factorial,
placebo- controlled trial. Clinical Therapeutics 41 (10): 1982-1995. Research
sponsored by AFT Pharmaceuticals.
4. Maxigesic® IV Phase 3 Exposure Study. Study ID No. AFT-MXIV-11. NCT04005755.
Extending the safety profile of the post-operative administration of an
intravenous acetaminophen/ibuprofen fixed dose combination: an open-
label, multi-center, single arm, multiple dose study. Submitted for publication.