The US-based biopharmaceutical company has filed for a Prior Approval Supplement (PAS) in anticipation in demand for its treatment for Hereditary Angioedema (HAE), a rare, genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein.
In data filed with the FDA, details of a two-phase expansion project were revealed in which ViroPharma proposed the expanded use of its parallel chromatography process, which was implemented earlier this year and is currently being used.
The data also included in-depth comparability testing at certain manufacturing stages from three conformance lots of industrial scale produced product, as well as stability data and lot release data.
ViroPharma’s intention is to run production across multiple shifts, essentially doubling capacity of the current manufacturing line and increasing the pharmaceutical drug numbers.
The company said it was expecting to receive approval for manufacturing at the industrial scale during the fourth quarter of 2010 with impact to sales from the beginning of 2011.
"The filing of our PAS for industrial scale manufacturing takes us one step closer toward making product at enhanced capacity available to many more patients with HAE," said Dan Soland, ViroPharma's chief operating officer.
"We now have increased confidence in our goal of gaining approval for this scale up initiative for Cinryze this year."
This announcement follows the news late last May that Cinryze manufactured through its parallel chromatography process had been launched onto the market. Cinryze was approved by the FDA in October 2008.
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product is used for the routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
ViroPharma’s intentions fall on the same day of another collaboration involving research into HAE therapeutics.
Dyax and Defiante, a subsidiary of the pharmaceutical company Sigma-Tau announced a partnership to develop and commercialise subcutaneous DX-88 (ecallantide) for its treatment of hereditary angioedema (HAE).
The deal will see Sigma Tau make a $2.5m upfront payment to Dyax and will purchase $2.5m in equity shares at a 50 percent premium above market value.
Dyax will also be eligible to receive over $100m in development and sales milestones related to DX-88 and royalties equal to 41 percent of product net sales.