PEPs: A pig in a poke

When Altus Pharmaceuticals Inc. decided to develop a recombinant product that would compete with marketed porcine-derived enzyme replacement therapies to treat pancreatic insufficiency, it thought it was going after another piece of low-hanging fruit. However, Phase III data released last week, in which Altus’ Trizytek met the primary endpoint but might not match results from porcine products, leave the competitive picture unclear.

The question for Altus is whether FDA’s preference for well-characterized, non-animal-based products will lead to regulatory approval without further trials...