Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, and Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company, have entered into a long-term collaboration for the development, supply and commercialisation of Xiapex (collagenase clostridium histolyticum), a novel, first-in-class biologic for the treatment of Dupuytren's contracture. In addition, work is on-going to file for approval of Xiapex for the treatment of Peyronie's disease in the EU.
Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize Xiapex for these two indications, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/ Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries. Since 2011, Xiapex has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway. Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialisation activities for Xiapex in Dupuytren's contracture and Peyronie's disease in these countries.
Xiaflex/ Xiapex has been approved by the US Food and Drug Administration, Health Canada and the European Medicines Agency as a treatment for Dupuytren's contracture for adult patients with a palpable cord, and is also in phase III development in Japan. In addition, a Xiaflex submission has been filed for approval in Australia for the treatment of Dupuytren's contracture.
"Today, Sobi and Auxilium have established a broad relationship, which we believe will build on the momentum and growth of Xiapex in the EU territories and to also offer, subject to regulatory approval, the first, effective non-surgical treatment for two diseases in multiple new geographies," said Adrian Adams, chief executive officer and president of Auxilium. "With the proven strength of Sobi's commercialisation and development organisation in these diverse markets, this relationship should further enhance our ability to bring this innovative product to a global audience."
"This relationship has been designed to leverage Sobi's extensive regulatory and marketing expertise, as well as our established local operating companies in many of these markets," said Geoffrey McDonough, chief executive officer and president of Sobi. "Xiapex already has a growing Dupuytren's physician base in the EU territories, and we plan to build on our track-record of achieving sustainable patient access to new and innovative treatments to make Xiapex a sustainable global solution for patient communities with few treatment options today."
Under the terms of the collaboration agreement, Auxilium will receive significant tiered double-digit royalties based on sales of Xiapex in Sobi's territories, which will also cover payment for product supply. Additionally, Sobi could make up to $40 million in potential sales milestone payments to Auxilium.
Auxilium will remain primarily responsible for the global development of Xiapex in Dupuytren's contracture and Peyronie's disease and will be responsible for drug manufacturing and supply. Sobi will be responsible for clinical development and regulatory activities and associated costs corresponding to any additional trials required in its licensed territories.
Dupuytren's contracture is a chronic condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, skin pits then nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient's fingers contract and the function of the hand is impaired. The incidence of Dupuytren's disease, inclusive of pits, nodules and cords, is highest in Caucasians, historically those of Northern European descent, with a global prevalence of four to six percent of the Caucasian population. Most cases of Dupuytren's contracture occur in patients older than 50 years.
PD can be a physically and psychosocially devastating disorder that results in varying degrees of penile curvature deformity and disease bother associated with painful erections, erection appearance, impact on intercourse, and intercourse frequency. PD is the development of collagen plaque, or scar tissue, on the shaft of the penis that may harden and reduce flexibility, thus occasionally causing pain and causing the penis to deform in a bend or arc during erection. PD is a heterogeneous disease with an initial inflammatory component.
Auxilium Pharmaceuticals, Inc. is focussed on developing and marketing products to predominantly specialist audiences.
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.