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Roche Limits HIV R&D But Emphasizes HCV Research - commentary
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Roche recently sent this letter regarding the scope of their activity for new drugs in HIV and HCV research and development. It appears as though they will discontinue internal R&D HIV efforts, but in the letter they say they will be interested in external R&D new HIV drugs and they committed to developing HCV drugs they are developing. Roche has a long history in HIV.
They marketed the first HIV protease inhibitor saquinavir. The first double protease inhibitor regimen, or boosted PI regimen was saquinavir plus ritonavir, which was a very potent therapy but had side effects and tolerability issues. Saquinavir utility over the years has been limited as other protease inhibitors were used more in treatment. Roche developed the first entry inhibitor Fuzeon. They put quite a lot of effort into developing this drug at a time when there was a great need for new drugs for patients with serious resistance to HIV drugs. Unfortunately the drug was difficult to administer and was expensive to make and purchase. It is administered by subcutaneous injection and can be associated with skin welts. Due to the high cost of manufacturing the drug the purchase price was high and there was ongoing friction between activists and the company regarding this.
In the letter below Roche commits to supporting saquinavir and Fuzeon in the market and global HIV efforts. It is important that Roche is committed to HCV new drug development. HCV is the number one cause of death and hospitalization besides AIDS for HIV-infected people. We desperately need better therapy for HCV-infected patients, particularly for genotype 1 and African-Americans. Due to developing Pegasys Roche is well situated to help in HCV.
Unfortunately, it appears as though we are entering a time now where new pipieline for HIV drug development appears to be thin, but this is following a period of several years where the new drug pipeline was rich with tipranavir, etravirine, darunavir, raltegravir, and maraviroc. Still to come and in the development stage are are elvitegravir, vicriviroc, TMC278, a maturation inhibitor bevirimat, and the Tanox infusion drug. Still there are probably additional HIV drugs in development we may not know about. At the recent Resistance Workshop, Idenix reported on a new NNRTI inhibitor for which early data suggests it might be effective against NNRTI resistant HIV, perhaps a third-generation NNRTI. There may be drugs in development that companies are not yet talking about, the latest trend is not to publicly discuss new drug development until the data looks good enough.
Only two days ago GSK announced I think publicly for the first time they are developing 3 new integrase inhibitors which appear in vitro to suppress raltegravir resistance but more research on their activity against raltegravir resistance is required to confirm this. This is very encouraging, but patients with serious drug resistance to current drugs will need several active drugs to combine in a new regimen. Seriously resistant patients need not 2 but 3 new active drugs to reach less than 50 copies and sustain it.
In summary, new HIV drug research is precious; I think we have taken it for granted and it should be embraced more closely. I strongly believe we need new HIV drugs, certainly for patients with extensive drug resistance, but also we need safer and more effective HIV drugs for firstline therapy. I don't think we can afford to lose large pharma's interest in developing new HIV drugs. Despite friction between companies and activists there needs to be a realization of the importance of maintaining big Pharma's commitment to HIV, and unfortunately I think many people including advocates and activists lose sight of this.
The carrot was lost in the 'carrot and stick' approach. Constant bashing of Pharma without making an intelligent effort to interact in a more comprehensive and better balanced relationship may be regretted. There is an important inter-relationship between government (local, State, and Federal), the Pharma/Biotech industry, researchers, and patients & advocates. A proper balance of this multi-faceted relationship is yet to be attained. Jules Levin
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.
Sincerely,
Jenny Edge-Dallas
Global Leader, HIV Franchise
Mike Nelson
International Communications Manager, Hepatitis and HIV
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