Bristol-Myers Squibb is on track to submitting three regulatory submissions for three internally discovered compounds by the end of the year, it said during an overview meeting with investors this week.
The company’s New Drug Application for its investigational hepatitis B treatment, entecavir, has already been accepted for priority review by the FDA. An NDA for muraglitazar, the first in a new class
of compounds to fight diabetes, and a Biologics License Application for abatacept, an investigational treatment
for rheumatoid arthritis, are expected to be submitted by the end
of 2004.
BMS also highlighted six additional compounds in development
including:
•LEA29Y, an in-house discovered investigational biologic that has
shown promise in solid organ transplant rejection in Phase II studies
•Edifoligide which is in Phase II development and is being investigated for the prevention of vein graft failure in coronary and peripheral bypass graft surgery.
•Ixabepilone, a novel epothilone analog in Phase II development to
treat certain cancers.
•Vinfluine, a Phase III cancer compound being co-developed with
Pierre Fabre Medicament S.A.
•MDX-010, a monoclonal antibody being investigated as a latestage
anti-cancer treatment
•Src/ABL Kinase Inhibitor, an internally discovered, multitargeted
investigational compound and being investigated in chronic myelogenous leukemia.