Renal insufficiency hydrocortisone drug was approved in Europe in November.
ViroPharma contracted Recipharm to carry out full commercial-scale manufacture of Plenadren®, a modified release hydrocortisone drug approved in Europe in November 2011 in Europe for the treatment of adrenal insufficiency in adults. ViroPharma is investing in new equipment at the Recipharm site to enable large-scale manufacturing of the drug. Recipharm will be able to use the new equipment for other projects, but ViroPharma will remain its first-priority client.
Plenadren was originally developed and taken through European development and approval by Swedish firm DuoCort Pharma. ViroPharma acquired the business on the back of European approval of Plenadren, in a deal worth SEK 220 million (currently about $32.2 million) up front, but which could top SEK 1 billion dependent on regulatory and commercial milestones. Plenadren is an oral, once daily dual-release hydrocortisone tablet that comprises an outer layer that releases the drug immediately, and a delayed release inner core. Orphan drug designations for Plenadren have been granted in the EU, Switzerland, and the U.S.
Now operating as a subsidiary of ViroPharma, DuoCort started life as a project company of incubator PULS (Partners for Development investments in Life Sciences), which was founded in Sweden in 2002 to act as an incubator and investor for early life science projects, primarily in the drug development field. The incubator has to date established seven project companies.