Done deal times two

ViroPharma agrees to buy DuoCort Pharma weeks before its orphan drug Plenadren is granted European Marketing Authorization for adrenal insufficiency

Lloyd Dunlap
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HELSINGBORG, Sweden—Swedish specialty pharma company DuoCortPharma AB recently announced that the European Commission has granted aEuropean Marketing Authorization for Plenadren (hydrocortisone, modifiedrelease tablet), an orphan drug for treatment of adrenal insufficiency inadults, bringing these patients their first pharmaceutical innovation in morethan 50 years.
 
 
In late October, ViroPharma Inc. of Exton, Pa., signed adefinitive agreement to acquire privately held DuoCort. The acquisition ofDuoCort will further expand ViroPharma's orphan disease commercial productpipeline.
 
 
"This acquisition is consistent with ViroPharma's objectiveof broadening our orphan drug portfolio of therapies for patients with seriousconditions who lack effective treatment options," says Vincent Milano,ViroPharma's president and CEO. "Plenadren will be an important drug forpatients with Addison's disease and other chronic adrenal insufficiencies, andis the first new drug in this therapeutic area in over 50 years. Our commitmentto patients suffering from rare diseases is strong, and we are unwavering inour belief that all patients—including those suffering from suchdiseases—deserve safe and effective therapies. We are pleased to be in aposition to add Plenadren to our growing portfolio of orphan products forunderserved patients with critical needs."
 
 
Developed by DuoCort, Plenadren is a dual-release hydrocortisonereplacement therapy designed to better mimic the normal physiological cortisolprofile in order to improve outcomes for patients suffering from adrenalinsufficiency. Plenadren is given as an oral tablet once daily. It has an outerlayer releasing hydrocortisone immediately and an inner core releasing the restof the drug more slowly during the day. Although glucocorticoid hormonereplacement therapy for adrenal insufficiency has been available for decades,studies have recorded complications and co-morbidities including prematuredeath, impaired quality of life, increased risk of cardiovascular diseases anddecreased bone mineral density in treated patients, most likely because it isdifficult to match the natural secretion pattern of cortisol.
 
 
Maria Forss, CEO of DuoCort Pharma, says, "the marketingauthorization for Plenadren in Europe is an important step towards addressingthe unmet needs of these patients."
 
 
As of 2006, it was estimated that 125,000 patients in the EUsuffer from chronic adrenal insufficiency. Plenadren received its OrphanMedicinal Product Designation from the EU in May 2006, and received EuropeanMarketing Authorization from the European Commission Nov. 3, 2011. The approvalof Plenadren follows the positive opinion adopted by the Committee forMedicinal Products for Human Use (CHMP) in July 2011. Plenadren is now approvedfor marketing in all countries of the European Union (EU) as well as in theEuropean Economic Area (EEA), namely Iceland, Norway and Lichtenstein.
 
 
On closing, ViroPharma will pay an upfront closing cost of$33 million. Additionally, there are contingent milestone payments of up to$130 million associated with manufacturing, sales thresholds and territoryexpansion. ViroPharma anticipates peak year sales for Plenadren could reach upto $50 million dollars.
 
 
In 2004, ViroPharma sold certain of its early-stagebiodefense assets, including compounds, assays and other intellectual propertyrelated to the development of antiviral drugs targeting the smallpox virus andviral hemorrhagic fever viruses, to SIGA Technologies Inc., a New York-basedcompany recently in the news concerning a squabble between the U.S. Departmentof Health and Human Services and Food and Drug Administration over the merit ofits ongoing smallpox anti-viral development program amidst claims that thecontract award was influenced by SIGA CEO Ronald Perelman's politicaldonations, which are said to have included a $50,000 contribution to PresidentObama's inauguration.
 


Lloyd Dunlap

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