Pharmacia, the international drug company that is being taken over by Pfizer, has launched an initiative to extend access to its antiretroviral drug delavirdine (sold in the USA as Rescriptor).
The company, backed by Pfizer (which is in the process of acquiring Pharmacia), has agreed a deal with the Netherlands-based not-for-profit International Dispensary Association (IDA) under which:
- IDA can license generic drug companies to produce delavirdine for sale in Africa and other selected countries;
- A full dossier of information for licensing and on drug manufacture will be provided by Pharmacia, to speed the production and approval of generic versions;
- Generic versions of the drug will be made distinctive so they cannot be confused with Pharmacia/Pfizer's version of the drug;
- Licenses would be non-exclusive and generic drug makers would be encouraged to compete on price;
- A royalty of 5% will be payable to Pharmacia/Pfizer.
The drug delavirdine works in the same way as the commercially more successful drugs nevirapine and efavirenz, and is vulnerable to the same resistance mutations. It has been held back by a number of factors including:
- Dosing three times daily - although it may be possible to reduce that to twice daily;
- High pill burden (12 capsules a day) - although these can be dissolved in a drink;
- It cannot be taken with the TB drugs rifampicin or rifabutin, which reduce levels of delavirdine.
There is further information about delavirdine on aidsmap here.
In essence, it seems unlikely that delavirdine will ever become a first choice for HIV treatment. However, if this strategy works it may be possible for other companies to follow suit with more obviously useful drugs, across a wide range of medical conditions.
Friedman MA et al. Out-licensing: a practical approach for improvement of access to medicines in poor countries. Lancet 361:341-345, 2003. [available online as a PDF file here.]