Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the Company received a $7.5 million regulatory milestone from Pfizer, Inc. (Pfizer) following the first sale of XIAPEX® in Germany, a major EU market. XIAPEX is now available for sale in the United Kingdom, Germany, Denmark, Sweden, Finland, Norway and Austria. XIAPEX is a new non-surgical treatment option for Dupuytren's contracture in adult patients with a palpable cord and is the first injectable treatment to be approved in the EU for the treatment of Dupuytren's contracture.
Auxilium has now earned $52.5 million of regulatory milestones related to the Dupuytren's contracture indication and is eligible to receive up to $22.5 million in additional regulatory milestone payments for this indication. The remaining $22.5 million will be paid in $7.5 million increments, following Pfizer's first sale of XIAPEX in each of the remaining major markets of the EU. Pfizer has the marketing rights to collagenase clostridium histolyticum for Dupuytren's contracture in the 27 countries of the EU and 19 Eurasian countries.
"We are pleased to see our close collaboration with Pfizer bring XIAPEX, a novel, non-surgical alternative to new patients suffering from the debilitating effects of Dupuytren's contracture in additional European countries," said Armando Anido, Chief Executive Officer and President of Auxilium.
Prices for XIAPEX have been published in Austria, Denmark, Norway and the United Kingdom and are in the range of U.S.$1,000 to U.S.$1,400 per vial at current exchange rates.
Dupuytren's disease is a slowly progressive connective tissue disorder that can cause an affected finger to bend into the palm of the hand.(1) It affects approximately 3-13% of the European population.(2) The disease starts in the palm of the hand with the appearance of a number of small lumps (called nodules), made of cells that can produce abnormal deposits of collagen.(1) As the disease progresses, excess collagen continues to build up and may eventually form into a rope-like cord under the skin.(1) The cord extends from the palm into the finger and can gradually contract or bend the finger permanently toward the palm, known as Dupuytren's contracture.(1) Once contracture has occurred, the affected finger often interferes with the patient's ability to carry out everyday tasks.(1)
About XIAPEX (Collagenase clostridium histolyticum)
Collagenase clostridium histolyticum is a combination of two purified collagenases (collagenase is an enzyme capable of breaking down collagen), derived from the bacterium Clostridium histolyticum. It is the first pharmacological treatment to be developed for Dupuytren's contracture and may be an alternative to invasive and often complicated surgery for patients in the EU. Collagenase clostridium histolyticum is administered by local injection directly into the Dupuytren's cord a procedure which can be carried out in an outpatient setting. It works by breaking down the structure of the cord and, 24 hours after injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the finger. If contracture remains four weeks after treatment, another injection can be administered into the same cord, and the finger extension procedure can be carried out again. Injections and finger extension procedures may be administered up to three times per cord, at approximately four-week intervals.
Further details and product information will be available in the European Public Assessment Report on the web site of the European Medicines Agency at www.emea.europa.eu.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer Inc. has marketing rights for XIAPEX® in 46 countries in Eurasia and Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has two projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease and is in phase II of development for treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.