EC decision on dual release Plenadren tablet is expected by year end.

ViroPharma will buy Swedish glucocorticoid replacement therapy firm DuoCort Pharma for $33.6 million up front, as long as the latter’s MAA-filed adrenal insufficiency drug, Plenadren®, is approved by the European Commission. The EC’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive view on the modified release hydrocortisone tablet in July, and a final decision by the European regulator is expected by the end of the year.

The acquisition deal is in addition dependent on the EC’s confirmation of Plenadren’s orphan drug designation in Europe (the Committee for Orphan Medicinal Products confirmed in September that the drug’s orphan designation status would be maintained), and an amendment of the agreement with the product’s current contract manufacturer. In October 2010 DuoCort sealed a deal with Recipharm for scaling up the manufacture of Plenadren. The deal took the form of a risk-sharing collaboration under which Recipharm was to co-invest in the scale-up along with DuoCort Pharma.

If all the stipulations of the acquisition deal are met, Viropharma will make its $33.6 million up-front payment to purchase DuoCort, and will be eligible to make contingent milestone payments of up to another $131 million related to manufacturing, sales thresholds, and territory expansion. $25 million of this would relate to specific regulatory milestones, and up to $107 million relates to commercial milestones.

Plenadren has been developed as a once-daily, dual-release oral glucocorticoid therapy that combines both rapid release and extended release characteristics in a single tablet. DuoCort claims the tablet thus has a release profile designed to more closely mimic the body’s natural secretion of cortisol than current formulations of hydrocortisone that require multiple daily doses and can lead to highly variable cortisol levels.

ViroPharma anticipates that peak annual sales for Plenadren could reach $50 million. “Plenadren will be an important drug for patients with Addison disease and other chronic adrenal insufficiencies, and is the first new drug in this therapeutic area in over 50 years,” comments Vincent Milano, ViroPharma’s president and CEO.

A named patient program for Plenadren is currently in place in the EU, which ViroPharma says it expects to continue until commercial launch of the drug. In April DuoCort signed up U.K. firm Clinigen to manage the named patient program.

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