[Congressional Record (Bound Edition), Volume 152 (2006), Part 15]
[Extensions of Remarks]
[Page 20682]
[From the U.S. Government Publishing Office, www.gpo.gov]




     TRIBUTE TO JOHNSON & JOHNSON AND TIBOTEC THERAPEUTICS FOR THE 
                 DEVELOPMENT OF A NEW DRUG FOR HIV/AIDS

                                 ______
                                 

                          HON. DONALD M. PAYNE

                             of new jersey

                    in the house of representatives

                      Thursday, September 28, 2006

  Mr. PAYNE. Mr. Speaker, I rise today to congratulate Johnson & 
Johnson and Tibotec Therapeutics on its entry into the HIV/AIDS market 
with the launch of Prezista. On June 23, 2006 the U.S. Food and Drug 
Administration (FDA) granted accelerated approval to the anti-HIV 
medication PrezistaTM (darunavir) tablets. Prezista, a 
protease inhibitor previously known as TMC114, was developed by Tibotec 
Pharmaceuticals Ltd. and will be marketed in the U.S. by Tibotec 
Therapeutics. Prezista is indicated for treatment-experienced adult 
patients, such as those with HIV-1 strains resistant to more than one 
protease inhibitor.
  I am pleased that a company in my home state of New Jersey has 
responded to the HIV/AIDS crisis in a time when new innovations are 
essential in order to provide life saving medications to HIV/AIDS 
patients.
  Mr. Speaker, as you may know, the U.S. Food and Drug Administration, 
FDA, has granted accelerated approval to the anti-HIV medication 
PrezistaTM (darunavir) tablets. Prezista, which is a 
protease inhibitor previously known as TMC114 was developed, by Tibotec 
Pharmaceuticals Ltd.
  The FDA accelerated approval procedures allow for earlier approval of 
drugs that provide a meaningful therapeutic advantage over existing 
treatment for serious or life-threatening diseases. This approval is 
based on the 24-week analysis of HIV viral load and CD4+ cell counts 
from the pooled analysis of the TMC114-C213, POWER 1, and TMC114-C202, 
POWER 2, studies.
  One of the most challenging obstacles in the care for HIV is finding 
proper therapies for treatment-experienced patients. Prezista is an 
important new option for the thousands of people with HIV in the United 
States who are resistant to more than one protease inhibitor.
  Additionally, the Fair Pricing Coalition believes that Tibotec 
Therapeutics has priced Prezista responsibly. This is a particularly 
thoughtful move on the company's part since it recognizes the crisis of 
federal funding constraints faced by payers in and out of government 
and the health care system. I am pleased to see that the spirit of 
philanthropy has not eluded the makers of this much needed drug by 
putting the needs of patients first.
  Johnson & Johnson recognizes the unparalleled global challenge posed 
by the AIDS epidemic and our response to collaborate in the 
international response to HIV, particularly through providing access to 
our HIV medications. For sub-Saharan Africa and Least Developed 
countries, Johnson & Johnson is actively pursuing licensing and 
technology agreements in order to enhance the affordability of 
Prezista. They are in negotiations with generic manufacturers and 
anticipate that by working with generic manufacturers, Prezista/
darunavir can be offered at substantially reduced prices.
  Mr. Speaker, I congratulate the makers of this drug and encourage 
more companies to follow in their footsteps.

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