[Congressional Record Volume 154, Number 10 (Wednesday, January 23, 2008)]
[Extensions of Remarks]
[Page E66]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    TRIBUTE TO TIBOTEC THERAPEUTICS

                                 ______
                                 

                         HON. G.K. BUTTERFIELD

                           of north carolina

                    in the house of representatives

                      Wednesday, January 23, 2008

  Mr. BUTTERFIELD. Madam Speaker, I rise today to commend and 
congratulate Tibotec Therapeutics for their innovation and corporate 
responsibility in developing new, effective treatments for people 
living with HIV/AIDS. On Friday, January 18, 2008, the Food and Drug 
Administration approved Tibotec's second HIV drug, 
INTELENCETM (etravirine), for the treatment of HIV 
infection.
  In my home state of North Carolina, there are an estimated 31,000 
people living with HIV/AIDS, many of whom may not be aware that they 
are infected with this life-threatening illness. Unfortunately, the 
Black Community in North Carolina as well as others across the southern 
United States are disproportionately impacted by HIV/AIDS. A high 
percentage of people in these communities are diagnosed in the later 
stages of HIV disease--a fact that further complicates their chances 
for successful ongoing treatment. Furthermore, Black women are 
disproportionately impacted by HIV/AIDS in our state, with an HIV 
infection rate almost seventeen times higher than among non-Hispanic 
white women.
  We are all aware of the success HIV therapies have had on prolonging 
and enhancing the quality of life for those infected with HIV/AIDS. As 
the infected population lives longer and becomes increasingly resistant 
to current treatment regimens; there is a growing need to focus on 
access to newer therapies for treatment experienced. HIV drug 
manufacturers are being challenged to meet the treatment needs of this 
changing population. Federal and State governments, public health 
programs, medical and community-based providers in addition to drug 
manufacturers are all challenged to find ways to better serve 
disproportionately impacted and underserved communities.
  Tibotec Therapeutics is also a leader in reaching out to underserved 
communities highly impacted by HIV. A primary example of this is 
Tibotec's GRACE study, a first-of-its- kind clinical trial that will 
compare gender differences in the efficacy, safety and tolerability of 
an FDA-approved HIV therapy in women, and will also explore racial 
differences in treatment outcomes.
  Tibotec Therapeutics, an operating company of Johnson & Johnson, has 
a strong history of advancing the science of HIV treatment, and 
INTELENCETM is another shining example of this cutting-edge 
research and development. INTELENCETM, also known as TMC 
125, is the first new drug in the NNRTI class to be approved in a 
decade. It brings new hope to HIV patients, whose HIV virus has become 
resistant to other HIV therapies, including drugs in the same NNRTI 
class. Notably, the FDA approved INTELENCETM through an 
accelerated approval procedure--a process that is reserved for the 
early approval of drugs that show a meaningful therapeutic advantage 
over existing treatments for serious or life-threatening diseases.
  Finally, Tibotec Therapeutics acted responsibly in pricing 
INTELENCETM, a fact recognized by many leaders in the HIV 
community. In fact, one leading HIV patient advocate stated, ``With the 
introduction of INTELENCE, Tibotec Therapeutics has demonstrated 
exceptional leadership in working with the HIV community in an effort 
to address pricing and access issues. Tibotec has repeatedly recognized 
the necessity of responsibly pricing HIV products and should be 
commended for its leadership in this regard.'' This type of responsible 
corporate behavior is especially welcomed in my state of North 
Carolina, which has struggled in the past to provide access to HIV 
therapies for eligible lower-income individuals.
  In closing, I would like to once again, I commend Tibotec 
Therapeutics for its innovation and corporate responsibility. I applaud 
the fact that North Carolinians living with HIV/AIDS will now have 
access to a new and important treatment option, affording them the 
possibility of living healthier and productive lives.

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