Johnson & Johnson’s Tibotec Pharmaceuticals unit on Thursday announced it had granted multiple licenses to generic drug manufacturers “to provide copies of [the experimental HIV/AIDS drug rilpivirine hydrochloride] TMC278 in sub-Saharan Africa, India and parts of Asia if it’s approved by regulators,” Bloomberg Businessweek reports.

“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,” the news service writes. The announcement by “the world’s largest maker of health-care products, may prompt similar deals by rival drugmakers, Warren said in a telephone interview” (Nussbaum, 1/28).

Under the agreement Tibotec will provide the Indian subsidiary Matrix Laboratories, Hetero Drugs Limited of India, and Aspen Pharmacare of South Africa “with the technical information and knowledge to allow them to manufacture the single agent product,” according to a company press release (.pdf). While “[t]he generic pharmaceutical manufacturers in India will have rights to market the product in sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India[,] Aspen will have rights to market the product in SSA including South Africa,” the release states (1/27). 

“The generic companies will pay Tibotec royalties of 2 percent to 5 percent of what they are paid for the pills, according to [a company] statement,” Bloomberg Businessweek writes, adding, “Tibotec expects to do no more than break even on the arrangement” (1/28).

“Tibotec has applied for marketing approval of rilpivirine in the U.S., Europe, Canada, Switzerland, Australia, Russia, and South Korea. The drug, a non-nucleoside reverse transcriptase inhibitor, is intended to treat HIV in adults who have not used another therapy,” the Associated Press/Forbes adds (1/27).

Bloomberg Businessweek includes reactions to the announcement by James Love, director of the non-profit Knowledge Ecology International, a group that works on expanding access to medicines in developing countries, and Kaitlin Mara, a spokeswoman for the Medicines Patent Pool.

Though “J&J appears to be the first AIDS drugmaker  to license generic copies of its drug before approval … [t]he deal may have a downside if it means J&J is rejecting calls for drugmakers to license patents to The Medicines Patent Pool, a United Nations-sponsored effort to encourage access and research into lower-cost treatments, Love said,” according to the news service. Love also noted that deal to license the drug for the 48 U.N.-designated LDCs “excludes North Africa, Latin America outside of Haiti and Asian countries including Pakistan, the Philippines and Indonesia,” Bloomberg Businessweek writes. Karen Manson, a Tibotec spokeswoman, is also quoted in the article.

The Tibotec press release quotes Will Stephens, Vice President of Johnson & Johnson’s Global Access & Partnerships for Janssen Global Services, as saying: “Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the U.S. and Europe underscore the seriousness and speed with which we’re working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens” (1/27).