This is a good deal for developing nations getting drugs at an affordable price. This makes Johnson and Johnson the first pharma company to license generic copies before approval is even given. J and J licensed the drug for use in 48 countries listed as least developed countries to include India and South Africa. Latin America, outside of Haiti is excluded from the list so good news for Haiti. Tibotec is the generic drug company owned by Johnson and Johnson.
The AIDS drug, named TMC278 is still waiting regulatory approval in the US from the FDA and in Europe. The plan here is to get the drug to the countries in need as fast as possible. The generic companies who manufacture the drug will pay Tibotec royalties of 2 to 5 percent. A Mylan pharma subsidiary in Pennsylvania will be one of the licenses granted as well as Aspen Pharmacare Holdings in South Africa.
This will be interesting to see how this all works out and eventually see how it might maybe roll over into access for drugs in the US with this type of process someday. BD
“Non-nucleoside reverse transcriptase inhibitors (NNRTIs) have become important components of HAART due to their high potency and convenience. Given the relatively small number of approved NNRTIs and their clinical benefits, novel NNRTIs with improved tolerability, convenience and binding to HIV-1 reverse transcriptase are needed.
Multi-disciplinary discovery research has yielded TMC278, a new NNRTI (a diarylpyrimidine (DAPY) derivative), which shows high intrinsic activity against both wild-type HIV-1 in vitro and against HIV strains harboring resistance inducing mutations. It is well tolerated, has a long half-life and allows once-daily dosing.”
Jan. 28 (Bloomberg) -- Johnson & Johnson struck the first deal to license an experimental AIDS drug before regulatory approval, reigniting debate over how much companies should do to speed access to HIV treatments in poor countries.
J&J’s Tibotec Pharmaceuticals unit has agreed to let three generic drugmakers provide copies of TMC278 in sub-Saharan Africa, India and parts of Asia if it’s approved by regulators, the company said yesterday in a statement. If past AIDS drugs are a guide, that could make the pill available for a hundredth of the price that customers pay in the United States, said Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition.
“It is important and significant news,” he said. “This could indeed facilitate these products making it into the developing world at lower prices than could be offered just by the developers of the drugs themselves.”
Warren said Truvada, the AIDS drug made by Foster City, California-based Gilead Sciences Inc., sells for $35 to $40 a pill in the United States while generic versions may cost 40 cents in Africa, offering a guide for the potential savings.