The drugmaker has been sending e-mails to AIDS activists saying its HIV/AIDS research is coming to end after several compounds failed to advance in clinical work. As a result, Roche has decided to "refocus our resources within virology on diseases in which we can deliver substantial improvements over existing medicines," according to the e-mail.
The decision marks the end of a long-running effort to develop or market HIV/AIDS drugs, which was often characterized by testy relations with AIDS activists who, more than once, picketed Roche headquarters in Nutley, New Jersey, most recently over pricing for the Fuzeon medication.
As Peter Staley notes on his POZ blog, Roche was the third company to market an antiviral, a me-too called Hivid, in 1992, which followed Retrovir in 1987, and Videx in 1989. Then came the first protease inhibitor, Invirase, later reformulated as Fortovase, although this was eclipsed by rival meds.
Then came Fuzeon, which Staley calls "a crucial salvage therapy over the last five years, offering thousands of people with AIDS their last hope after becoming resistant to first-and second-line therapies." But Fuzeon was later overtaken by easier-to-take meds. "Roche fumbled the development and marketing...working poorly with and infuriating AIDS activists along the way," he writes.
A Roche spokeswoman confirms the move, although emphasizes that HCV development work will continue and notes that HCV is a "big co-infection" issue in the HIV/AIDS community.
In response to your request, we are writing to provide further clarity on Roche's presence in the HIV field. Please share this information with other community members as you deem appropriate. As you know, Roche has a long-standing heritage of innovation in HIV since we initiated our protease inhibitor discovery project more than twenty years ago. Our work has resulted in major contributions in this field, among them the development of PCR diagnostic and viral load technology, the introduction of the first protease inhibitor, and the introduction of the first fusion inhibitor to patients in 2003 - despite the considerable technical challenges we faced in producing this very complex molecule on a large scale.
For several years, we have been investigating compounds targeting the CCR5 entry pathway and the reverse transcriptase enzyme. All these compounds were in pre-clinical studies, and therefore at least six years away from availability to patients. While we had initially been hopeful about their potential, we now have concluded that none would provide a true incremental benefit for patients compared to medicines currently on the market - and therefore do not warrant further development. We had hoped to provide you with this information in an in-person meeting.
Assessing this setback in the context of our overall Virology Disease Area, we have decided to refocus our resources within Virology on diseases in which we can deliver substantial improvements over existing medicines. However, when we identify a significant scientific breakthrough in HIV externally, we would certainly assess our ability to make a further contribution to the field, as we did with Fuzeon.
Developing new treatments for viral diseases continues to be a priority.
In particular, we have a promising pipeline of new drugs for the treatment of hepatitis C, which is one of the most significant causes of mortality among patients living with HIV. Furthermore, our scientists are currently examining a range of other viral diseases to determine those which offer the potential for us to make a difference.
Roche will, of course, continue to support our medicines that are currently available for the treatment and monitoring of HIV-related disease, including Fuzeon, Invirase and Viracept, as well as our molecular diagnostic tests. In addition, we remain committed to increasing the access to our HIV medicines for people living with HIV in resource-limited countries with programmes such as our preferential patent and pricing policy and the AIDS Technology Transfer Initiative.
If you would like additional information on the discontinued HIV programmes, we would be happy to engage in further dialogue with you.
Jenny Edge-Dallas Global Leader, HIV Franchise
Mike Nelson International Communications Manager, Hepatitis and HIV
Hat tip to the POZ blog