Bangkok AIDS Conference
Roche Zap 15 July 2004
Activists took over the booth of Roche Laboratories for the inaccess of nelfinavir/Viracept and T20-T1249 in the south and in the North.
On the one hand, Roche has never agreed to grant Southern laboratories the voluntary licences they would need to make cheap copies of Viracept, the leading protease inhibitor. on the other hand, they refused to implement a price-differentiation policy for buyers in developing countries, while they had committed to do so in the frame of the Accelerating Access Initiative Program in 2000. yet one knows that those minimal agreements, ratified and implemented by the rest of the pharma industry, re still very insufficient to meet the "Access for All" objective put forward at the XV International AIDS Conference.
Thus, in Cameroon, Roche's nelfinavir/Viracept is the only molecule the CENAME -- Centrale Nationale d'Achat des Médicaments Essentiels: Cameroon's Trading Group for Treatment -- buys at the highest cost, whereas this very product is part of the first lines of treatment indispensable for the HIV+ people who are in the incapacity of taking fixed-dose ARV combinations (FDCs, i.e. Triomune)
Roche's tariff policy is not more acceptable in Northern Countries: T20/Fuzeon, a molecule mostly prescribed in cases of treatment failure, costs $53 a day, a price that makes it inaccessible to most PLWHAs not benefiting from a solid healhcare system.
Moreover, on January 6th, 2004, the firm declared: "We wish to announce to you that, following formulation problems, T1249 clinical development is stopped." Given the multiplication of treatment resistances and the absence of new therapeutic perspective, abandoning T1249 is signing many peoples death penalty.
T1249, after T20, was to become the second product of a new class of molecules called ENTRY INHIBITORS. Developed by American lab Trimeris under Roche's marketing and commercial supervision, these new medicines, by blocking the virus' entry into the cells before they get infected, allow us to foresee a more efficient control over the infection process. They thus offer a new chance of survival for people confronted with a major treatment failure. In France, such cases, for which none of the treatment available on the market is efficient, represented 5 to 10% of PLWAs in 2003. In this context, continuing the development of T1249 is hence vital for PLWAs.
T1249 as well as T20 are polypeptides and composed of dozens of AAHs that cannot be administered orally unlike the rest of ARVs. Today T20 is administered in twice-a-day injections, with a main undesirable effect: nodules appear around injection zones and can last up to a month. Some people see their body covered with dozens of impact points. Because of this main disadvantage, most physicians hesitate to prescribe it more broadly, which contributes to explain, withe the product's high cost ($20,000 a year), Fuzeon's commercial failure. Roche had planned sales up to $400 million a year, yet Fuzeon American sales have remained below $11 million for the first three semesters 2003.
Following this failure, Roche Laboratory wished to develop a T1249 formulation that would require less injections (twice a week for instance), as to ensure a greater commercial success for the new molecule. Roche's decision to stop its development would allegedly be due to Trimeris' problems in developing a new presentation for the product.
Roche's decision is outrageous for several reasons:
The absence of new treatment prospects from the last CROI makes access to T-1249 absolutely indispensable for PWAs.
This outrageous behavior by Roche is another testimony to industry's incapacity to demonstrate full corporate responsibility in the face of a crucial medical challenge: the rise of drug resistance.
At a time where so many patients are in treatment failure, it is criminal for a drug company to stop the development of a product on purely commercial grounds.
Contact person: Fabrice Pilorgé -- 04 066 75 15 email@example.com
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