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High Potency & Cytotoxics

hpcyto

High Potency & Cytotoxic products generally contain APIs which evoke the indicated response when administered at a low concentration. Due to their potency and toxicity these molecules need to be manufactured under specialised conditions, catering for both employee health and safety as well as product efficacy.

Our offerings in this category cover a wide range of therapeutic areas such as steroids, oncolytic and hormonal replacement therapy products.

FY17 Highlights

  • Signed a local promotional partnership agreement on Imuran which has been successful in reducing generic conversion in Japan and allowed us to maintain our category share in a competitive therapy area
  • Increase in demand for Imuran and Eltroxin in MENA driven by active promotion
  • Overall supply of Alkeran has improved and this provides an opportunity to expand global sales as supply is stabilised

Key brands

BrandTherapeutic category
AlkeranOncolytic
EltroxinThyroid hormone replacement
ImuranImmuno-modulator
OvestinEstrogen hormone replacement
PurinetholOncolytic

% of total group revenue

11%

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 2017 R’billion 2016 (CER)* R’billion% change
Total4,74,7
Revenue
Developed Europe 1,5 1,6(9)
Latin America0,80,725
Other territories2,4 2,4 2

• Constant exchange rate: FY16 restated at FY17 average exchange rates. Please note that all commentary is based on FY16 CER revenue in order to enhance the comparability of underlying performance.

Performance

Total revenue from this portfolio remained flat in the 2017 financial year. Performance was impacted by a 10% decline in Developed Markets revenue, mainly attributable to poor performance in Developed Europe where revenue fell 9% to R1,5 billion. Latin America, Russia and South Africa led the performance in Emerging Markets where overall revenue increased 17% to R2,0 billion.

Developed Europe

Performance in Developed Europe was negatively impacted by supply challenges related to Thyrax which was caused by a delay in the transition of the manufacture of this product from MSD to Aspen. Revenue growth was further hampered by increased generic competition for some of our key brands and the disruption caused by the change in distribution model in Europe. Strong performance in the United Kingdom was partially offset by the devaluation of the British Pound following Brexit. Promotional efforts in Russia were key to driving volume growth in Ovestin despite increased generic competition.

Latin America

The positive growth in Latin America was a result of the recovery of Decadurabolin and Durateston in Brazil as we intensified our promotional efforts following a stock-out in the previous financial year. Corticosteroids such as Meticorten and Meticortelone recorded double-digit growth supported by the commercial team’s focus on general practitioner training in order to ensure the correct usage of the products.

Other territories

Revenue in Japan was negatively impacted by the increased generic substitution of Decadron under the government incentive scheme aimed at increasing generic usage. Supply disruptions due to manufacturing site changes also negatively impacted year-on-year revenue growth in the other Asian countries.

The products driving growth in this segment in Australasia were Ovestin, Eltroxin and Eutroxsig. The non-reimbursed status of Eltroxin is an issue, but initiatives to ensure enhanced revenue from this brand are ongoing.

In South Africa, we launched a new Eltroxin formulation in June 2017 which involved a change to microcrystalline cellulose as the excipient, as opposed to the previous lactose-based product. Eltroxin’s volume share of the Thyroid Preparations segment in South Africa increased from 60,5% at June 2016 to 62,8% at June 2017, as measured by IMS.

Prospects

The securing from Teva of the licence for the New Drug Applications for two conjugated estrogen brands and the rights to commercialise these in the United States is an exciting future opportunity within the High Potency & Cytotoxic Portfolio.

We aim to establish Aspen as a recognised player in the Women’s Health segment by leveraging the strong base of API capabilities for this therapy area at Oss. We see an opportunity to position Aspen as a leading supplier in the hormonal and endocrine fields in Europe. The focus in Asia and South Africa will be on maintaining and growing our positions in Imuran and Eltroxin respectively, and managing competition from generics.