[Congressional Record Volume 154, Number 10 (Wednesday, January 23, 2008)]
[Extensions of Remarks]
[Page E64]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  RECOGNIZING TIBOTEC THERAPEUTICS FOR THEIR INNOVATION AND CORPORATE 
RESPONSIBILITY IN DEVELOPING NEW TREATMENTS FOR AMERICANS WITH HIV/AIDS

                                 ______
                                 

                         HON. ROBERT E. ANDREWS

                             of new jersey

                    in the house of representatives

                      Wednesday, January 23, 2008

  Mr. ANDREWS. 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, for the 
treatment of HIV infection.
  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.
  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 TMC125. 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.
  I would also like to recognize Tibotec Therapeutics for their 
outstanding work with the HIV patient and physician communities during 
the development and approval of both PREZITSATM and 
INTELENCETM. Tibotec Therapeutics worked closely with 
leaders in the HIV community on the development of the pivotal clinical 
trials that led to FDA approval of this product. 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.
  In addition, 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.''
  Once again, I commend Tibotec Therapeutics for its innovation and 
corporate responsibility. I applaud the fact that Americans 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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