With an investor call looming, ViroPharma ($VPHM) and its partner are responding quickly to the FDA's rejection of production expansion plans for its drug Cinryze, manufactured in the Netherlands.
The Exton, PA, company reported this week the FDA made "three comments related to a portion of the planned cleaning validation" in a complete response letter, and one would require additional action. The FDA also has yet to complete a review of the company's January responses from a September inspection of the facility. The C1 inhibitor concentrate for hereditary angioedema (HAE) is produced by Sanquin from U.S. source plasma at a plant in Amsterdam.
Robert Pietrusko, ViroPharma's vice president, global regulatory affairs and quality, said the two companies would immediately begin responding to the FDA, and the work could be wrapped up quickly. There are no remaining technical comments posed by FDA, he said.
"We remain confident in our ability to gain approval of the industrial scale manufacturing of Cinryze in 2012," Pietrusko said.
It intends to bring the investment community along on its resubmission plans and action dates during its earnings call later this month.
ViroPharma has big expectations this year for Cinryze. The company last month projected U.S. sales of the med would reach between $310 million and $330 million in 2012, a dramatic increase from the $250 million to $260 million in Cinryze sales projected for 2011.
Cinryze, approved in the U.S. in 2008, received approval in the EU and the European Economic Area last June. In January regulators granted an expedited review of the drug in Canada, which has no approved treatments for HAE. Last year ViroPharma also struck an $83 million deal for an exclusive license for a delivery platform from Halozyme Therapeutics ($HALO) that would allow for development of a subcutaneous formulation of the drug. It currently is approved for intravenous administration.
When ViroPharma expanded its licensing agreement with Sanquin in 2010, it agreed to fund €1MM worth of research a year for 5 years and loan Sanquin the money to pay for plant expansion.
- here's the release