Auxilium Pharmaceuticals, Inc, a specialty biopharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) issued US Patent No. 7,811,560 claiming, among other things, purified collagenase, the active component in Auxilium's product Xiaflex (collagenase clostridium histolyticum). The patent entitled "Compositions and methods for treating Collagen-mediated diseases" is expected to expire in July 2028. The Company also announced that it has filed continuation applications with the USPTO, which, if granted, may expand the scope of patent claims covering Xiaflex.
The patent's independent claims recite a drug product, a process for producing the drug product, and pharmaceutical formulations comprising the drug product. The claimed drug product consists of isolated and purified clostridial collagenase I and II, with a mass ratio of about 1:1, and purity of at least 97% as measured by reverse phase high-performance liquid chromatography. The process claims include processes for making the drug product. The pharmaceutical formulation claims recite the drug product with appropriate excipient(s). Dependent claims recite particular additional components of the drug product and pharmaceutical formulations, as well as additional process steps.
"We are very pleased that Xiaflex now has patent protection which we expect will expire in July 2028," said Armando Anido, chief executive officer and president of Auxilium Pharmaceuticals. "With one approved indication for Xiaflex, a second in late-stage clinical trials, and many more potential indications in the pipeline, we believe that extending our patent protection for the next 18 years is an important accomplishment."
Auxilium Pharma 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 orthopaedic, general, and plastic surgeons who focus on the hand, and rheumatologists.