Swedish Orphan Biovitrum Release: Xiapex Approved For The Treatment Of Peyronie's Disease In Switzerland
Swedish Orphan Biovitrum AB (publ)
Xiapex is also approved in Switzerland for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
Sobi has signed an agreement with Endo Pharmaceuticals Inc. 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.
About Peyronie's disease
Peyronie's Disease (PD) is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis. The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection. PD can result in varying degrees of penile curvature deformity and disease "bother" (encompassing concern about erection appearance, erection pain and the impact of PD on intercourse and on frequency of intercourse). PD is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13 percent of cases[i]. After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phasei. The incidence of PD is estimated between 3 and 9 per centii; however the disease is thought to be underdiagnosed and undertreatedi.
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 or in the plaque on penis. 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 Dupuytren's affected finger. As a complement to Xiapex injection treatment for Peyronie's disease, modelling of the penis is needed. Modelling is performed 24-72 hours after the second injection of the cycle in an attempt to further disrupt the plaque and help straighten the penis.
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.
For more information please contact
Sobi contacts:
Media relations
Investor relations
Charlotte af Klercker, Corportae Communications
Jörgen Winroth, Vice President, Head of Investor Relations
T: +46 70 297 327
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
charlotte.afklercker@sobi.com
jorgen.winroth@sobi.com
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Xiapex is also approved in Switzerland for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
Sobi has signed an agreement with Endo Pharmaceuticals Inc. 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.
About Peyronie's disease
Peyronie's Disease (PD) is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis. The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection. PD can result in varying degrees of penile curvature deformity and disease "bother" (encompassing concern about erection appearance, erection pain and the impact of PD on intercourse and on frequency of intercourse). PD is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13 percent of cases[i]. After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phasei. The incidence of PD is estimated between 3 and 9 per centii; however the disease is thought to be underdiagnosed and undertreatedi.
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 or in the plaque on penis. 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 Dupuytren's affected finger. As a complement to Xiapex injection treatment for Peyronie's disease, modelling of the penis is needed. Modelling is performed 24-72 hours after the second injection of the cycle in an attempt to further disrupt the plaque and help straighten the penis.
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.
For more information please contact
Sobi contacts:
Media relations
Investor relations
Charlotte af Klercker, Corportae Communications
Jörgen Winroth, Vice President, Head of Investor Relations
T: +46 70 297 327
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
charlotte.afklercker@sobi.com
jorgen.winroth@sobi.com
Help employers find you! Check out all the jobs and post your resume.