Aspen granted generic license for the manufacture and supply of TMC278

27/01/11:

Johannesburg. Aspen (APN), South Africa’s leading pharmaceutical company, has announced that Irish-based Tibotec Pharmaceuticals has granted it a non-exclusive license to manufacture, market and distribute the Anti-retroviral (“ARV”) compound, rilpivirine hydrochloride (TMC278), pending approval of the molecule which could then be prescribed for patients commencing ARV treatment for the first time as well as for those who have previous ARV treatment experience.

“This agreement further strengthens Aspen’s close working relationship with Tibotec in the supply of ARV’s and will further expand Aspen’s already extensive portfolio of HIV/AIDS medicines, thereby providing patients and physicians with increased clinical options”, said Stavros Nicolaou, Aspen Senior Executive.

“TMC 278 is being viewed as a compound with a number of potential benefits over existing treatments and is set to play an important role in the future management of HIV and AIDS. It is well tolerated, has a long half-life and allows once-daily dosing.”

The agreement entitles Aspen to manufacture TMC278 25 mg and to market TMC278 throughout sub-Saharan Africa (“SSA”), including South Africa. Fixed-dose combinations are, in certain instances, preferred by public health treatment programs and contain multiple molecules formulated into a single tablet to ease dosage management for patients. Tibotec has chosen to collaborate with select manufacturers in order to increase access to a sustainable supply of TMC278 in areas of high HIV/AIDS prevalence.