The announcement today that Janssen R&D Ireland pharmaceutical company will give the nonprofit International Partnership for Microbicides exclusive worldwide rights to develop, make and market sexual and reproductive health products with the antiretroviral dapivirine was heralded by both organizations as a stride for global public health in general, and HIV prevention for women in particular.
The catch? The first product to be covered by the agreement is still being tested for proof that it will work, in trials not due to yield results until late 2015.
So why the excitement? On the obstacle-strewn path towards an HIV prevention method that can be controlled by women, the agreement addresses two of the challenges: wide-scale distribution of products to the women who need them most, and funding to continue to develop products that address the greatest threats to women’s health. It will speed availability of a product that has been more than a decade in development, and, in the event that the first product is effective, will ease development of more.
The agreement will cover a vaginal ring containing the antiretroviral dapivirine now in trials across Africa to determine if it can prevent HIV acquisition, and it will cover multi-purpose products, including a vaginal ring combining dapivirine and a contraceptive.
While progress in HIV prevention and treatment efforts have seen infections drop across many of the hardest hit countries, HIV, pregnancy and childbirth remain the leading causes of death among women of reproductive-age worldwide. The quest for products that help women to protect themselves from HIV and unintended pregnancy is “a race against time,” IPM chief executive Zeda Rosenburg says in the announcement.
“The ability to prepare for access is accelerated quite a bit by this agreement,” AVAC director Mitchell Warren said today. “Further down the road it allows IPM to build a wider pipeline.”
It is a pipeline that will benefit women outside of the highest burden countries, he added. “A combination ring would have benefit all over the world.”
A vaginal ring that can stay in place for a month at a time would be one answer to the results of the VOICE — Vaginal and Oral Interventions to Control the Epidemic trial — which found low adherence to products requiring daily use. Researchers are still interpreting the results of the trial.
In addition, Warren said, the agreement sets an example.
“No one can do this alone,” he said. “It’s time to figure out how to provide products in the field. We hope that other companies will be just as engaged.”