Roche and Trimeris announce intention to manufacture commercial supplies of anti-HIV fusion inhibitor T-20

Hoffmann-La Roche and Trimeris, Inc. have announced that the Roche manufacturing facility in Boulder, Colorado has been selected to manufacture commercial supplies of the investigational anti-HIV compound, T-20, the first of a new class of drugs called fusion inhibitors which is being co-developed by Roche and Trimeris.

Fusion inhibitors block fusion of HIV with host cells before the virus enters the cell and begins its replication process. Development of this new anti-HIV drug class is considered important, especially for use by HIV patients who have multi-drug- resistant HIV strains and are failing on current HIV therapy.

There has been a concern that development of T-20 could be significantly delayed, due to the difficulties encountered in manufacturing commercial quantities of the compound. In particular, the HIV patient advocacy community has been closely monitoring the drug’s development, in the hope that the compound could be made available soon through an “expanded access” program. These programs traditionally have made promising experimental drugs available prior to regulatory approval to patients in need of additional treatment options.

“We have committed substantial financial and technical resources, so that we can start scaling up to produce this peptide in metric tons rather than kilograms,” said David Reddy, PhD, Virology Franchise leader, Roche. “This is because we recognize the therapeutic potential that T-20 may have for the growing number of patients in need of new options to control their HIV infection.

The production of peptides in such quantities represents a major challenge that we are pleased to undertake. We encountered similar challenges when the protease inhibitors were first introduced. Trimeris has already transferred the production process to Roche Colorado, where dedicated manufacturing capability has been established and manufacturing for clinical supply has been successfully initiated.

Comment

We look forward to the rapid roll out of the promised access programmes. This commitment to scaling up manufacturing capability will initially be required in order to first meet the supply issues for the Phase 3 planned to start enrolment in Europe and the US this year. An expanded access programme for T-20 is still not expected before the end of next year.