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    Stony Brook researchers tap international markets for Xiaflex; new applications for frozen shoulder, cellulite possible

    Next on the horizon: Potential U.S. approval for Peyronie’s disease, and trials for treatment of Frozen Shoulder syndrome and cellulite

    STONY BROOK, N.Y., June 21, 2012 – Two years after receiving FDA approval as the U.S.’s first non-surgical treatment of Dupuytren’s disease, a drug called XIAFLEX® (collagenase clostridium histolyticum or CCH), developed at Stony Brook University has already been administered to over 20,000 patients in the U.S. as treatment for the debilitating hand disorder. XIAFLEX, marketed and distributed in the U.S. by Auxilium Pharmaceuticals, Inc. (Malvern, PA), is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. Now, the drug is being marketed internationally to patients who are afflicted and it is in early-stage testing for potential new applications – including treatment of cellulite as a cosmetic procedure – according to researchers at Stony Brook University School of Medicine.

    XIAFLEX is injected into the contracted fingers of patients with Dupuytren’s disease to break down the fibrous cords that result from the

    Left to right: Edward Wang, MD, Associate Professor of Orthopaedics, Division of Shoulder, Elbow and Hand Surgery; Marie A. Badalamente, PhD, Professor in the Department of Orthopaedics; and Lawrence C. Hurst, MD, Professor and Chairman, Department of Orthopaedics, Stony Brook University School of Medicine

    progressive accumulation of collagen in the fascia of the hand, causing the fingers to contract and severely limiting motion and hand function. Early and late stage clinical work on the drug was done over the past 18 years by Lawrence C. Hurst, MD, Professor and Chairman, Department of Orthopaedics, Stony Brook University School of Medicine, and Marie A. Badalamente, PhD, Professor in the Department of Orthopaedics.

    The development of XIAFLEX is a prime example of bringing a groundbreaking new treatment from “bench to bedside” in an academic medical center, said Kenneth Kaushansky, MD, MACP, Senior Vice President, Health Sciences, and Dean, Stony Brook University Medical Center.

    “This is a singular achievement,” he said. “It epitomizes the soul and essence of an academic institution. This is what everyone in academic medicine dreams about.”

    Of the over 20,000 patients treated with XIAFLEX in the United States, Hurst estimates that 500-600 of those patients were treated at Stony Brook. XIAFLEX was developed, brought for FDA approval and is being marketed in the United States by Auxilium Pharmaceuticals Inc. of Malvern, PA and in Europe, under the brand name XIAPEX®, by Pfizer, Inc. Additionally, the drug is being developed in Japan by Asahi Kasei and in Australia, Canada, Mexico and Brazil by Actelion, Inc.

    Dupuytren’s disease encompasses the earlier stages of disease where pits or nodules form in the hand, as well as the more severe Dupuytren’s contracture, which manifests as a palpable cord in the finger. The disease is thought to affect predominantly those aged 40 and older, and it affects more males than females, Hurst said. Dupuytren’s contracture patients as young as age 24 have been treated at Stony Brook.

    According to the medical literature, 3-6 percent of adults in certain parts of the world could be affected by Dupuytren’s disease, with the highest

    Alexander B. Dagum, MD, Professor of Surgery and Orthopaedics, Stony Brook University School of Medicine

    incidence among Caucasians of Northern European ancestry. The number of potential cases in Europe and Scandinavia ranges from 13 million to 27 million, according to Badalamente. The condition is more common in men than in women, and is thought to increase in incidence with age, diabetes, epilepsy, smoking and excessive use of alcohol.

    XIAFLEX was designated by the FDA in the mid ‘90s as an “orphan drug” for the treatment of Dupuytren’s contracture Hurst said, meaning that it treats a disease affecting fewer than 200,000 patients in the United States annually. However, since that approval, further research suggests that global estimates among adult Caucasians for Dupuytren’s disease could run as high as 3-6 percent.

    “This is a first-in-category drug,” Hurst said. “There’s never been another like it.” It is among only a handful of drugs developed in the State University of New York (SUNY) system working with the pharmaceutical industry to receive FDA approval, he pointed out.

    Recently, Auxilium announced positive top-line results from both phase III trials of XIAFLEX for the treatment of Peyronie’s disease, a potential second indication for the drug. XIAFLEX was well tolerated and demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus placebo. Auxilium plans to file a supplemental Biologics License Application with the FDA by the end of 2012.

    Now, investigators at Stony Brook are focused on developing additional new treatment options for CCH. Working with Auxilium Pharmaceuticals, Badalamente is teaming with Edward Wang, MD, Associate Professor of Orthopaedics, Division of Shoulder, Elbow and Hand Surgery, Stony Brook University School of Medicine, to examine CCH as a treatment for Frozen Shoulder syndrome, and she is teaming with Alexander B. Dagum, MD, Professor of Surgery and Orthopaedics, Stony Brook University School of Medicine, and Chief of the Plastic and Reconstructive Surgery Division, Stony Brook University Hospital, to examine CCH as a cosmetic procedure for the treatment of cellulite.

    The application for treating Frozen Shoulder syndrome, or adhesive capsulitis, is in a phase IIa clinical trial being conducted by Auxilium, Badalamente said.  For cellulite treatment, the drug is in a phase Ia trial being conducted by Auxilium for its potential use to break down the collagen “honeycomb” or scaffold-like structure of cellulite in order to smooth out the skin, she said.

    A double-dose study for simultaneously treating Dupuytren’s patients with multiple contracted fingers in one hand is also underway by Auxilium, Hurst said. Currently, separate fingers are treated with separate doses, which are given at one-month intervals.

    Hurst and Badalamente have been widely recognized within their field for their work, which was published in the prestigious scientific medical journal New England Journal of Medicine in September 2009. They have traveled and lectured worldwide to such far-flung destinations as Sweden, Greece, Norway, Japan, France, Spain, England and Australia. They have presented to the British Society for Surgery of the Hand, the Japanese Society for Surgery of the Hand, and the Spanish Society for Surgery of the Hand. Surgeons from around the world have made site visits to Stony Brook, including contingents from the United Kingdom, Italy, Japan, Spain and Austria.

    In 2009, Hurst, Badalamente and Wang shared the Clinical Research Award from the Orthopaedic Research and Education Foundation (OREF) for Outstanding Orthopaedic Clinical Research. Hurst and Badalamente also co-authored a book called “Dupuytren’s Disease” with Raoul Tubiana, MD, FRCSEd (Hon) and Caroline Leclerq, MD, of the Institut de la Main in Paris, and Evelyn J. Mackin, PT, of the Hand Rehabilitation Foundation in Philadelphia.

    Basil Rigas, MD, DSc, Interim Vice Dean for Clinical Affairs at Stony Brook University School of Medicine, calls Dr. Hurst a “megastar” whose work has been inspirational to him in his research and to others in the medical field.

    “We are affecting the healthcare of the whole world,” he said. “This is translational medicine at its best.”

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    About Stony Brook University School of Medicine:

    Established in 1971, the Stony Brook University School of Medicine includes 25 academic departments. The three missions of the School are to advance the understanding of the origins of human health and disease, train the next generation of committed, curious and highly capable physicians, and deliver word-class compassionate healthcare. As a member of the Association of American Medical Colleges (AAMC) and a Liaison Committee on Medical Education (LCME) accredited medical school, Stony Brook is one of the foremost institutes of higher medical education in the country. Each year the School trains nearly 500 medical students and over 480 medical residents and fellows. Faculty research includes National Institutes of Health-sponsored programs in neurological diseases, cancer, cardiovascular disorders, biomedical imaging, regenerative medicine, infectious diseases, and many other topics. Physicians on the School of Medicine faculty deliver world class medical care through more than 30,000 inpatient, 80,000 emergency room, and approximately 350,000 outpatient visits annually at Stony Brook University Hospital and affiliated clinical programs, making its clinical services one of the largest and highest quality on Long Island, New York. To learn more, visit www.medicine.stonybrookmedicine.edu.

    Please see Full Prescribing Information and Medication Guide at https://www.xiaflex.com/.

    For more information, or to report a side effect or a product complaint, call 1-877-XIAFLEX (1-877-942-3539).