European Medicines Agency approves Xiapex® for concurrent treatment of palpable cords


18-11-2015

Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Medicines Agency has approved Xiapex® (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.

 

"This approval is valuable for patients suffering from Dupuytren's contracture," said Birgitte Volck, Chief Medical Officer of Sobi. "This label expansion provides a non-surgical option for treating two cords concurrently during one doctor's visit."

Dupuytren's contracture is a progressive hand disease that can present with multiple collagen cords limiting finger movement and hand function. The application, seeking expansion of the labelling for the concurrent treatment of two palpable cords, is based on positive results from the global, multicentre Phase 3b MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) trial, together with data from Sobi's partner's earlier studies (AUX-CC-861 and AUX-CC-864). The study also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection. These studies were conducted by Auxilium Pharmaceuticals Inc., which was acquired by a subsidiary of Endo International plc (Endo) in January 2015.

Xiapex was approved in the European Union (EU) for the treatment of Dupuytren's contracture in adult patients with a palpable cord in 2011. Sobi and Endo have signed an agreement giving Sobi the exclusive rights to commercialise Xiapex for the treatment of Dupuytren's contracture and Peyronie's disease in 71 Eurasian and African countries. Sobi is Marketing Authorisation Holder (MAH) for Xiapex in the 28 EU Member States, as well as Norway and Iceland. Xiaflex® (collagenase clostridium histolyticum) is the trade name for Xiapex used in the United States.

In January 2015 Xiapex (collagenase clostridium histolyticum) was granted approval by the European Commission 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.

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About Dupuytren's Contracture
Dupuytren's disease 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." [i],[ii]

About Xiapex
Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment for Peyronie's disease and 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 collagen plaque and reduces the contraction. Xiapex is administered by local injection directly into the Dupuytren's cord in the finger. During 24-72 hours after the injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the Dupuytren's affected finger. 

About Sobi
Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com

About Sobi Partner Products
Sobi Partner Products (SPP) is a business unit within Sobi that offers a unique commercial platform for partners with niche and specialty products. SPP provides extensive knowledge and local experience through our direct presence across EU, Eastern Europe, Russia, Middle East and North Africa. We apply an integrated commercial, medical and market access approach to products that address important unmet needs, spanning from named patient use (NPU) programmes, through to reimbursement and full commercialisation, primarily in the Centre of Expertise setting.

 [i] Luck JV. Dupuytren's contracture: a new concept of the pathogenesis correlated with surgical management. J Bone Joint Surg Am. 1959;41(4):635-664.

[ii] Desai SS, Hentz VR. Collagenase clostridium histolyticum for Dupuytren's contracture. Expert Opin Biol Ther. 2010;10(9):1395-1404.

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Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients.

Sobi