Sobi becomes market authorisation holder for Xiapex in Europe

Stockholm, Sweden and Chesterbrook, Pa., 7 April, 2014 -- Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced  that Sobi became the Market Authorisation Holder (MAH) for Xiapex® (collagenase clostridium histolyticum), in 28 EU member countries, Norway, and Iceland on 3 April, 2014.

Xiapex/ Xiaflex® is a first-in-class biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord and in the US for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. As the MAH, Sobi may now if it so elects, file for market authorisation for Xiapex for the treatment of Peyronie's disease and work is ongoing for that filing in the EU. Sobi holds the exclusive rights to commercialise Xiapex for the Dupuytren's contracture and Peyronie's disease indications, in these countries subject to applicable regulatory approvals. 

 

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About Dupuytren's Contracture

Dupuytren's contracture is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with Dupuytren's there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger's range of motion (how much a person can move or straighten them). Once the Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord."

About Xiapex

Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment for Dupuytren's contracture and may be an alternative to invasive and often complicated surgery for patients. Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and reduces the contraction. It is administered by local injection directly into the Dupuytren's cord - a procedure which can be carried out in an outpatient setting. Twenty-four hours after the injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the finger.