Date: 28 January 2011

Source: Pharmalot

Link: http://www.pharmalot.com/2011/01/a-jj-hiv-drug-cheap-generics-and-a-patent-pool/


In a bid to make HIV meds more accessible to poor countries, the Tibotec unit of Johnson & Johnson yesterday announced a licensing deal with several generic drugmakers to manufacture, market and distribute an investigational an HIV med in India, sub-Saharan Africa and Least Developed Countries (which ones are these, you ask? Here is the list). The drug in question is a non-nucleoside reverse transcriptase inhibitor.

The generic drugmakers, including Hetero Drugs, Matrix Laboratories and Aspen Pharmacare, will be entitled to manufacture a once-daily 25 mg version of Tibotec`s TMC278 as a single agent med and a fixed-dose combo product. In exchange, the companies will pay royalties of two percent to five percent, limit their gross profit margins and will be responsible for regulatory filings with the World Health Organization and ANDA approvals. Tibotec, which is part of J&J`s Janssen unit, has already submitted its med for approval in the US, Europe and several other countires.

We believe that voluntary licensing is an important mechanism by which to expand access to our HIV portfolio, including our newest medicines,? says Will Stephens, vp of global access & partnerships at Janssen Global Services, in a statement e-mailed to us. ?Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the US 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.?

However, the move received a mixed reaction. On one hand, Tibotec was praised for taking such a step to provide greater access to a needed med. But some patient advocates say Tibotec did not go far enough because there are other developing countries where such meds are needed. Tibotec also ran into a snag yesterday as the fixed-dose combo with Gilead Sciences? Truvada pill was rejected by the FDA (see this).

For instance, the Medicines Patent Pool, a new initiative designed to streamline patent licensing for producing generic versions of HIV meds and lower prices, called this a ?move in the right direction.? The organization, in fact, has been talking to Tibotec for more than a year about voluntary licensing of all their anti-retroviral drugs drugs in low and middle-income countries.

However, the MPP thinks Tibotec could go further by expanding the number of developing countries involved and increasing the number of licensees, which is ?important to encourage robust competition for dynamic price reductions,? MPP`s Kaitlin Mara writes us. Among the countries not included in the agreement - all of Latin America, except for Haiti, and all of North Africa, along with several countries in Asia, such as Thailand, Malaysia, the Phillipines, Indonesia and Pakistan.

And Knowledge Ecology International, a non-profit advocacy group that focuses on intellectual property issues that affect access to meds, speculates the announcement is part of ?a larger effort to undermine? the MPP. Last week, the MPP received a boost when the US government got behind the initiative and is now urging the World Health Organization to embrace the concept (look here).