Plant approval only bright spot in dismal ViroPharma quarter

The only good news that came out of ViroPharma's second-quarter financial report today was the much improved sales of its C1 inhibitor concentrate Cinryze, which should continue to grow after the FDA finally signed off on industrial scale production at a plant in the Netherlands.

ViroPharma ($VPHM) faced a tough quarter when industrial scale production at Sanquin's Amsterdam plant where Cinryze is made was held up by the agency. In February, the FDA made "three comments related to a portion of the planned cleaning validation" in a complete response letter, one requiring additional action, ViroPharma reported. At the time, the agency also hadn't completed its review of responses made about a September inspection of the facility.

But this week ViroPharma reported that it had received FDA approval of the Prior Approval Supplement (PAS) for industrial scale manufacturing for Cinryze, prompting CEO Vincent Milano to make lofty predictions for its future.

"With the recent expansion in manufacturing capacity, continued strong patient adds and consistent patient dosing rates in the United States, we believe that peak year sales for Cinryze as it is currently marketed, will exceed $700 million," Milano said in a release.

For 2012, the company says it expects Cinryze sales to range from $320 million to $335 million, making up the bulk of the company's forecast $450 million to $475 million. For the quarter, Cinryze made up $77 million of the company's $95 million in revenue, which fell from $128 million in the quarter a year earlier. It says sales were hammered by generic competition to its antibiotic Vancocin. The  company reported a $4.2 million, 6 cents a share, loss for the quarter. 

- here's the earnings release

Suggested Articles

The FDA asked five drugmakers to pull their version of extended-release metformin off U.S. shelves after finding carcinogen contamination.

The FDA backtracked on its earlier testing and found NDMA contamination in the extended release formulation of certain generic versions of metformin.

GSK has formed several collaborations across the globe that will use its AS03 adjuvant to develop vaccines against the novel coronavirus.