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This Little Pig-Free Product Goes To Market? Alnara's High Hopes For A PERT

This article was originally published in The Pink Sheet Daily

Executive Summary

Alnara claims its latest trial shows real-world effectiveness of liprotamase, formerly called Trizytek, and plans early 2010 NDA.

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FDA's Gastrointestinal Drugs Advisory Committee says in lopsided votes that Lilly's exocrine pancreatic insufficiency drug candidate Sollpura (liprotamase) lacks proof of efficacy.

Sollpura's Future After No Vote From Panel Might Include More Trials, Adult Indication

FDA's Gastrointestinal Drugs Advisory Committee says in lopsided votes that Lilly's exocrine pancreatic insufficiency drug candidate Sollpura (liprotamase) lacks proof of efficacy.

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Alnara, a Lilly subsidiary, says that its exocrine pancreatic insufficiency treatment is supported by two adequate and well-controlled trials, but FDA says that the product has changed so much that only one of them is relevant - and that one doesn't show strong enough efficacy.

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