Into Africa - Roche expands HIV tech transfer

These deals are the latest in the Swiss firm's AIDS Technology Transfer Initiative, kicked off in 2006 to provide free technical expertise to allow manufacturers in sub-Saharan Africa and other less developed countries to produce generic HIV medication based on Roche's Invirase (saquinavir) manufacturing processes. Another four transfer agreements were announced this morning, bringing the grand total to nine companies signing up for Roche's help in establishing their manufacturing processes. The latest companies to join the scheme are Regal Pharmaceuticals in Kenya, CAPS Holdings in Zimbabwe, Shelys Pharmaceuticals in Tanzania and Beximco Pharmaceuticals in Bangladesh. Each of these firms will apparently profit from on-site assistance from Roche reps at their manufacturing facilities, as well as from the company's headquarters in Switzerland. Roche has received expressions of interest from a total of 35 manufacturers in 15 'eligible' countries, though companies must fulfil certain criteria to be lucky enough to benefit from Roche's expertise. The most important requirement is apparently the possession of (or willingness to acquire) the film coated tablet machine required for saquinavir's manufacture, but Roche will also take into account applicants' facilities, capacity and general standards when considering whether to work with them on the technology transfer scheme. According to a company spokesperson, Roche then provides detailed, specific feedback to the potential partnering firm in terms of what needs to be done before they can be enrolled on the programme. Although the scheme has been running since January 2006, none of the companies have actually implemented the saquinavir manufacturing processes recommended by Roche as yet. "The regulatory timelines to register new medicines in Africa are very slow,"​ Roche spokesperson Maria Vigneau told in-PharmaTechnologist.com "We are still in the process [of transferring the expertise], but the timeline is in their hands." ​ The companies taking part in the technology transfer will be able to produce generic saquinavir throughout their countries, and will not need to apply for a voluntary license as Roche has committed not to enforce patents on antiretroviral meds within sub-Saharan Africa and those defined as 'least developed' by the United Nations. Roche will also provide regulatory guidance to the firms it is working with when it is time to submit their generic drugs for approval. Alongside the latest agreements, Roche has also started up a series of training seminars for local manufacturers, aimed at improving production processes in their manufacturing facilities. Roche's philanthropic scheme should indeed help strengthen and expand local manufacturing capabilities for HIV medicines in resource-limited areas of the world, and allow local distribution of essential medicines without reliance on the West. Roche recently felt the wrath of incensed non-governmental organisations (NGOs) working in African nations following the widespread contamination of one of the firm's other HIV meds, Viracept (nelfinavir), provided along with Invirase at knock-down prices to sub-Saharan Africa and other less developed countries. While the drug was completely recalled across Europe and patient registries established to keep an eye on patients, the situation in Africa is more challenging, with recall procedures unclear, lines of communications unreliable, and a lack of suitable alternative treatments. With poorer nations perceived by some as the pharmaceutical industry's refuse bin and the destination of drugs shunned by more developed countries, the fate of patients prescribed Roche's contaminated drug gave NGOs cause for concern, worried as they are that adverse reactions will go unnoticed and untreated. The Swiss firm went to lengths to brief NGOs on its efforts following the recall, but given the logistical difficulties in the regions concerned, it is perhaps inevitable that some patients will fall through the gaps. The firm's efforts to help establish in-country manufacturing capacity for these much needed HIV drugs will presumably go some way to helping repair the firm's reputation, though it is likely to be some time before any of the companies involved in the technology transfer are actively producing the meds for the local population.