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Thrombosis

thrombosis

Thrombosis occurs as a result of the body’s haemostatic pathway being activated inappropriately, leading to the formation of blood clots. Aspen’s global basket of anticoagulant thrombosis products is aimed at the prevention and treatment of thrombotic disease, including deep vein thrombosis, pulmonary embolism and acute coronary syndrome.

Our product range includes Fraxiparine and Mono-embolex (low molecular weight heparins) and Arixtra (a Xa inhibitor). Orgaran is a heparin derivative (heparinoid) indicated for the treatment of heparin-induced thrombocytopenia (“HIT”). HIT is an adverse reaction occurring in a limited number of patients undergoing heparin-related therapy.

FY17 Highlights

  • Exercised option to acquire Fraxiparine and Arixtra from GSK for commercialisation in China, India & Pakistan for a consideration of GBP45 million. The transaction became effective 31 December 2016
  • Double-digit growth in Emerging Markets

Injectable anticoagulants in all of Europe (Developed and Developing) recorded 1,4% volume growth. Developing Europe made up 25% of the total volume and grew 6% over the period while growth in Developed Europe was flat.

Source: June 2017 IMS

Key brands

BrandAPI
ArixtraFondaparinux
FraxiparineNadroparin
FraxodiNadroparin
Mono-embolexCertoparin
OrgaranDanaparoid

% of total group revenue

14%

bus-thrombosis

 2017 R’billion2016 (CER)* R’billion% change
Total5,7 6,0 (5)
Revenue
Developed Europe3,2 3,7 (14)
Developing Europe & CIS1,7 1,8 (2)
China0,3 >100
Other territories0,5 0,5 (3)

Performance

Revenue from Thrombosis declined 5% to R5,7 billion. Emerging Markets delivered robust revenue growth of 13% to R2,4 billion, but the portfolio retreated 16% in the Developed countries (predominantly Developed Europe) where sales of R3,3 billion were recorded.

Developed Europe

Performance in Developed Europe was negatively impacted by mandatory price cuts as a consequence of price referencing and increasing competition due to increased formulary inclusions for orals. Performance was also affected by a once-off change in our distribution model, with Arixtra being the most significantly impacted. Despite this challenging environment, IMS volumes as at 30 June 2017 showed positive growth in Monoembolex and Arixtra, while Fraxiparine remained flat.

Developing Europe & CIS

Injectable anticoagulant volumes grew steadily in Developing Europe & CIS where orals are considered a relatively more expensive treatment option. Our commercial teams have engaged in various initiatives aimed at improving profitability. While Fraxiparine posted positive single-digit growth, this was offset by Arixtra supply shortages in Russia.

Other territories

The thrombosis products acquired from GSK, together with the anaesthetic portfolios, have allowed Aspen the opportunity to significantly expand its footprint in China. We recorded positive year-on-year growth in China postacquisition of the thrombosis products. This follows three years of declining sales prior to the transition. Per IMS, the low molecular weight heparins sector in China grew 18% and was valued at USD622 million as at 30 June 2017. As we focus our detailing efforts on the thrombosis portfolio, we expect to add to the positive year-on-year growth in the 2018 financial year.

Latin America recorded double-digit growth in respect of this portfolio due to increased penetration of Arixtra into the private market, coupled with new launches in Chile and Mexico. Fraxiparine faced some pricing pressure due to the launch of an enoxaparin generic, which created a negative pricing environment in the low molecular weight heparin class.

Prospects

There is an opportunity to capture commercial synergies between the Anaesthetic and Thrombosis portfolios in hospitals. New indications for Fraxiparine will support broader access to hospital tenders and thus allow more patients to receive our products. Orals, biosimilar and possible generic competition remain challenges to the thrombosis portfolio. Our growth strategy is aimed at managing price pressure through retail growth, launching existing products into new regions and growing volumes in key segments. Our reputation for quality manufacturing and superior API sourcing are key differentiators in this segment and will be instrumental in helping us combat the pricing pressures anticipated.