"AIS’ methotrexate program strikes me as a wasted effort. When was the last time a company made big money by selling an injectable formulation of a generic drug available as a pill? "
AIS explained the rational during their last CC. They've done market research & gotten input from over 150 physicians & opinion leaders before proceeding with its development.
1. Methotrexate is co-prescribed with alot of biologics given to treat RA at home.
2. IM injection is approved, but most individuals go to the docs office for their injection.
3. Once you start titrating higher levels of oral methotrexate 12-15 milligrams its not as effectively absorbed in gastro tract (sub-therapeutic level) & you start getting some adverse effects.
BPAX, threw a curve ball today. They've increased the range of participants required for their libigel safety trial. Speculation the NDA filing will be pushed back & they'll have to raise money.