12:00 AM
Jan 24, 2011
 |  BioCentury  |  Product Development

Really insufficient

A poster child for head-to-head trials: Lilly's Solpura vs. pig enzymes

Solpura liprotamase for exocrine pancreatic insufficiency could be the poster child for why it's a good idea to run head-to-head clinical trials. If those had been done early on, the product might now be on the market - or not. Either way, it would be hard to argue that three companies and their shareholders wouldn't have saved time and money. And it would be equally hard to argue patients wouldn't be better off knowing they have access to the best product.

Instead, no one really knows exactly how the recombinant-based Solpura stacks up against the marketed porcine-derived pancreatic enzyme products (PEPs). Nor is it clear, given the limited amount of data available, how good PEPs really are.

And even though Solpura presumably would be a more consistent product than any of the PEPs, it was clear from the start that it did not measure up to FDA's efficacy targets, making a head-to-head comparison even more germane(see "PEP Talk," A11).

Despite the lack of a direct comparison, panelists at a meeting of the Gastrointestinal Drugs Advisory Committee this month said Solpura appeared to have modest efficacy compared to marketed PEPs. That, combined with unanswered safety questions, led to a 7-4 vote, with one abstention, that the product from Eli Lilly and Co. should not be approved without more trials.

"Given that the porcine enzymes aren't that great, I would want anything that was approved to be at least as good," said temporary voting member Jesse Joad, a pediatric pulmonologist and professor emerita at the University of California at Davis.

Patients with exocrine pancreatic insufficiency lack the digestive enzymes required for absorption of lipids. This causes malnourishment, resulting in massive weight loss, steatorrhea (excess fat in the feces), abdominal pain and diarrhea.

The condition is associated with cystic fibrosis (CF), pancreatitis and pancreatic cancer. In CF patients, it can lead to increased morbidity and death.

Solpura liprotamase (formerly TheraCLEC/ALTU-135/Trizytek) is a combination of a recombinant lipase with a fungal protease and an amorphous fungal amylase. The lipase and the protease are each cross-linked to improve stability compared with porcine-derived PEPs, which degrade over time, requiring patients to increase their dosage over the life of the products.

Two Phase III trials started...

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