Aspen manufactures Africa’s first generic ARVs

Pretoria – Aspen Pharmacare, Southern Africa’s largest generics manufacturer and JSE Securities Exchange listed pharmaceutical company, has announced the launch of Aspen-Stavudine – the first generic antiretroviral (ARV) drug developed and manufactured in Africa.

Stephen Saad, Aspen Pharmacare Group Chief Executive Officer said “Aspen-Stavudine is the first locally developed and manufactured generic ARV which presents a solution to what is largely an African problem. This initial ARV demonstrates Aspen’s commitment to healthcare in Southern African and underlines the scientific and manufacturing capabilities that exist within the country at Aspen’s Port Elizabeth based facilities.”

“Aspen-Stavudine fulfils the critical initial step in the company’s approach toward providing quality, affordable generic ARVs for millions of HIV/Aids sufferers. The product will form one element of a multi-faceted solution to containing the pandemic, the others including inter alia, appropriate nutrition, education, prophylaxis and other measures undertaken in government’s integrated HIV/Aids strategy.”

Aspen will sell Stavudine within the range recommended by the World Health Organisation (WHO), with Aspen’s pricing being competitive with major Asian suppliers reported on by the WHO. Aspen’s pricing structure against the originator is detailed in the table below:

Saad said Aspen’s pipeline of ARV’s should be bolstered shortly by the addition of generics for Didanosine, Combivir, AZT, 3TC and Nevirapine which have been submitted to the Medicine Control Council (MCC) for registration. Once registered, Aspen anticipates selling a cocktail therapy of ARV’s at below $1 per day. These additional licenses were made available to Aspen through license agreements with Bristol-Myers Squibb (BMS), GlaxoSmithKline (GSK) and Boehringer Ingelheim (BI).  As a result of these licenses, Aspen infringes no patents and has complied with all WTO rules and the GATT, GATS and TRIPS agreements.

“Aspen is proud that its scientists have developed these products in-house to meet to stringent regulatory requirements set by the Medicines Control Council (MCC). This includes bio-studies which results have shown Aspen generics to be consistent with the original product.  The short duration of the development time, together with Aspen’s manufacturing capability, offer hope to the healthcare industry.  Further, Aspen is presently in the process of enhancing its manufacturing facilities with the addition of a new multi-million rand oral solid dosage facility to service both domestic and offshore markets.”

“Aspen’s commitment to SA is demonstrated by our increased expenditure on local manufacture, development and the delivery of quality, affordable generic alternatives, including attention to Malaria, TB and HIV/Aids.  We remain of the firm conviction that initiatives such as these and our substantial investment in our new extended manufacturing facility, at a time where there has been a substantial rationalisation and withdrawal of Pharmaceutical manufacture from South Africa, will provide a Pharmaceutical sector contribution towards the stated national economic objectives of growth, development, poverty reduction and enhanced employment”.

Aspen is committed to playing a meaningful role in supporting government in its fight against HIV/Aids and pledges its ongoing commitment to South African’s future.