Johnson & Johnson response to Oxfam’s report “Investing for Life”
Business & Human Rights Resource Centre invited Johnson & Johnson to respond to the following items:
Press release: "Pharmaceutical industry is undermining its own future as millions of poor people denied access to medicines", Oxfam, 27 Nov 2007
Full report: “Investing for life - Meeting poor people’s needs for access to medicines through responsible business practices”, Oxfam, 27 Nov 2007
Johnson & Johnson sent this statement:
December 18, 2007
Johnson & Johnson Statement on Oxfam’s report, “Investing for life - Meeting Poor People’s Needs for Access to Medicines through Responsible Business Practices”
In the spirit of supporting constructive dialogue Johnson & Johnson and Tibotec appreciate this opportunity to comment on Oxfam’s report Investing for Life. We are providing here information that was shared with Oxfam during our December 2006 meeting regarding our access efforts. In addition, we are providing an update on the significant progress we have made since that meeting, especially in the area of ARV pricing in sub-Saharan Africa and least-developed countries. These include key elements in our global response to HIV/AIDS, including voluntary licensing, innovative drug design and delivery mechanisms.
Below, please find elements of our program that respond to the three issues stated as industry shortcomings by Oxfam.
R&D Investment
· In June of 2007 we initiated Phase II studies for TMC207, our lead investigative candidate for the treatment of multi-drug resistant tuberculosis (MDR-TB). Our goal is to continue to accelerate TB research in partnership with stakeholders and industry. This is the first investigational agent that has been studied specifically for the treatment of MDR-TB.
· In 2004 Tibotec provided a royalty-free license for their investigational antiretroviral TMC120 to the International Partnership for Microbicides (IPM), for its development as a vaginal microbicide for the prevention of HIV/AIDS.
· While Oxfam included this agreement in the IP section of their report, it seems that the fact of the agreement did not affect our ranking. This agreement marked the first collaboration in the microbicide field between a major healthcare company and a product development partnership, such as IPM. In addition, we continue to offer technical support and counsel to IPM for its continued research.
For more information, please see: http://www.tibotec.com/bgdisplay.jhtml?itemname=dw_rightblock1
· Tibotec has designed a once-daily antifungal product, MicMAT, for treatment of oral candidiasis, which is a major problem for HIV/AIDS patients in the developing world who are not receiving ARVs. The muco-adhesive technology (MAT) enables the sustained intra-oral delivery of miconazole for approximately twelve hours. MicMAT was developed primarily for developing countries and is marketed on a cost-recovery basis. For more information, please see: http://www.tibotec.com/bgdisplay.jhtml?itemname=dw_leftblock3
· Virco, Tibotec’s sister company, is partnering with a number of key NGO, academic and government institutions to provide their HIV resistance knowledge and interpretation to better understand the patterns of resistance in resource-poor settings in Africa, Asia and Latin America. In Africa, Virco will be the primary commercial partner in a unique public-private partnership called ART-A (Affordable Resistance Test for Africa), an initiative aimed at HIV Resistance technology transfer and capacity building in the developing world. For more information, please see: http://www.vircolab.com/news/detail.jhtml?itemname=NACAAP
Intellectual Property and Pricing Structures
· The current focus of our global access program is on PREZISTA, a protease inhibitor indicated for use in treatment-experienced patients (approved by US FDA in June 2006 and EMEA in February 2007).
· In April 2007, Tibotec announced a royalty-free, non-exclusive license agreement with Aspen of South Africa to register, package, commercialize and distribute PREZISTA™ (darunavir, formerly known as TMC114) for the treatment of HIV/AIDS in sub-Saharan Africa (SSA) and other least-developed countries (LDCs).
· Aspen and Tibotec will share in the responsibility for an ongoing effort to ensure prompt access to patients in the region. A framework has been created to grant a non-exclusive license to Aspen for the production of PREZISTA when demand increases such that generic manufacturing can provide significant cost reductions.
· As a result of the Aspen partnership, there will be a single co-branded product, under the brand name PREZISTA, distributed by Aspen and sold at a an ex-factory price to be set by Aspen as the market authorization holder not to exceed $3 a day—roughly an 85% discount off the US and EU commercial price. For more information, please see: Reuters Coverage.
In closing, all of the above information is readily available to the public on Tibotec.com. Details of the Aspen agreement were also covered in the press just four months after our meeting.
Thank you for this opportunity to comment.