"This
decision has been taken as we have been unable to develop a viable oral dosage
formulation capable of delivering the desired drug levels in patients with multidrug
resistant HIV. "As
in all of our drug development programs, GSK investigated several formulations
of brecanavir. We conducted extensive studies in an effort to identify a formulation
that would maximize therapeutic benefit for people living with HIV, especially
those who are heavily treatment-experienced. Ultimately, our formulation work
could not overcome the limitations of the brecanavir molecule which make consistent
delivery of target drug levels unachievable. "Clinical
trial investigators and their Institutional Review Boards (IRBs) are being notified
of the situation and directed to transition their patients to marketed antiretrovirals
or appropriate treatments available through expanded access programs. GSK will
work with our clinical trial investigators to identify and implement alternative
treatment arrangements for individual trial patients. "GSK
is dedicated to excellence in the care of individuals with HIV infection, and
we will continue our efforts to find effective treatments with improved resistance
profiles for these patients," said Lynn Marks, MD, Senior Vice President,
GSK Medicine Development Center for Infectious Diseases. "Despite this disappointing
outcome with brecanavir, we remain unwavering in our commitment to find new solutions
to meet the challenges of HIV/AIDS." | 
GlaxoSmithKline
(GSK) announced on December 18 that the company has discontinued clinical development
of its experimental HIV protease inhibitor brecanavir (formerly GSK 640385) due
to "insurmountable issues regarding formulation." At the time of the
announcement, brecanavir was in Phase II development. 
