AFT adds COMBOGESIC Tablets to Hikma Agreement in US

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com

Confidential







08 August 2024
AFT adds COMBOGESIC
®
(acetaminophen and ibuprofen)
Tablets to Hikma Agreement in US.
AFT Pharmaceuticals (NZX: AFT, ASX: AFP) today announces an Agreement with Hikma
Pharmaceuticals USA (“Hikma”) to distribute its patented
1
COMBOGESIC
®
Tablets, a
fixed dose combination (FDC) (acetaminophen and ibuprofen), non-opioid
analgesia in a single tablet for adult pain management to select markets in the United
States, the largest pharma market in the world.
2

The Agreement furthers the cooperation between the companies after the 21 April
2021 agreement between AFT and Hikma for the intravenous form, COMBOGESIC
®
IV,
and will cover market segments where the IV dose form will be used such as hospitals
and ambulatory surgical centres.
AFT Managing Director Dr Hartley Atkinson said: “COMBOGESIC
®
IV was launched by
Hikma in February this year and we believe that the addition of the oral dose form,
COMBOGESIC
®
Tablets will assist uptake of the IV dose form in addition to sales of the
tablet. As previously indicated, we are planning to see tablet sales start during this
calendar year. AFT will benefit from the agreement by means of a profit share.
Hikma is a global pharmaceutical company focused on complex and differentiated
generic and branded 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
3
,

and a
trusted, reliable partner and dependable source of over 760 high-quality generic,
specialty, and branded pharmaceutical products that hospitals, physicians, and
pharmacists need to treat their patients.

- ENDS –

This product has been approved for marketing in the United States by the U.S. FDA.
This product approval does not confer the right on Hikma, or any other party, to
market this product outside the United States.

For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.

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 investor.relations@aftpharm.com

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


About COMBOGESIC
®
IV
COMBOGESIC
®
IV is the only IV analgesic therapy formulated with 1,000 mg of
acetaminophen and 300 mg of ibuprofen, utilizing the synergistic effect of both
medicines for optimal pain relief.
4
It offers health care providers an advanced
approach to multimodal analgesia by combining active drug substances with
different mechanisms of action that harness additive or synergistic effects to provide
more effective pain relief compared with individual components used as single-
modality interventions.
4-6
COMBOGESIC
®
IV is supplied as a readily available solution
with no mixing required for administration.
4
It is administered as a 15-minute IV infusion,
every 6 hours as needed, not to exceed the maximum total daily dose of 4,000 mg
acetaminophen and 1,200 mg of ibuprofen in 24 hours.
4




About AFT Pharmaceuticals
AFT is a growing New Zealand based 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
1
. Our business model is to
develop and in-license products for in our markets of Australia, New Zealand,
Singapore, Malaysia, Hong Kong, USA, Canada, EU ex Ireland and UK, 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
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-
/positive Fitch)

Hikma helps put better health within reach every day
®
for millions of people around
the world. For more than 45 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 North America, 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 9,100 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

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com

Confidential
health technologies to people around the world. For more information, please visit:
www.hikma.com.


Footnotes
1. Multiple patents. FDA Orange book - COMBOGESIC N 209471 001 10532036 Sep 22, 2025
11197830 Feb 27, 2039 11534407 Feb 27, 2039 U-3553
2.https://www.statista.com/statistics/245473/market-share-of-the-leading-10-global-
pharmaceutical-markets/
3. IQVIA MAT May 2024, generic injectable volumes by eaches, excluding branded generics
and Becton Dickinson

4. COMBOGESIC
®
IV (acetaminophen 1000 mg and ibuprofen 300 mg) [package insert].

5. Daniels SE, Playne R, Stanescu I, et al. Efficacy and safety of an intravenous
acetaminophen/ibuprofen fixed-dose combination after bunionectomy: a randomized,
double-blind, factorial, placebo-controlled trial. Clinical Therapeutics. 2019;41(10).

6. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of post operative pain: a
clinical practice guideline from the American Pain Society, the American Society of Regional
Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on
Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131-
157.

COMBOGESIC
®
is a registered trademark of AFT Pharmaceuticals Limited. In ANZ, Middle East
and Asia the trademark, Maxigesic
®
is used.