SAN MATEO, Calif., Aug. 9 /PRNewswire/ -- BioForm Medical, Inc., a privately-held medical aesthetics company, today announced that it has entered into an exclusive licensing and distribution agreement in the United States with Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler) for the development and commercialization of Aethoxysklerol(R), the current leading sclerotherapy treatment in Europe for varicose veins. Aethoxysklerol is currently under clinical evaluation in a Phase III multi-center study for use in treating spider and reticular veins. This trial is designed to support U.S. Food and Drug Administration (FDA) approval requirements and is being conducted pursuant to a Special Protocol Assessment (SPA) with the FDA. Enrollment in this trial has been completed and BioForm and Kreussler intend to submit a New Drug Application (NDA) to the FDA in 2008, if the study is successful.
"In my practice, there are a large number of potential patients with spider or reticular veins that have chosen not to seek treatment due to the significant discomfort of many current treatment options," said Gary D. Monheit, M.D., a dermatologic surgeon at Total Skin & Beauty Dermatology Center, P.C., Birmingham, AL. "Based on the large body of clinical evidence abroad and in peer-reviewed publications, Aethoxyskerol may address these limitations, if approved by the FDA."
"I believe this product, once approved, may offer patients and physicians a less painful treatment option for spider and reticular veins," stated Neil S. Sadick, M.D., a dermatologist at Sadick Dermatology, in New York. "My colleagues abroad have shared their considerable positive experiences with Aethoxysklerol and we are looking forward to the potential introduction of this product to our patients in the United States."
Under the terms of the agreement, Kreussler will be responsible for conducting the clinical trial and regulatory filings for approval of Aethoxyskerol by the FDA, and, assuming approval is received, will exclusively manufacture the product for BioForm following approval. BioForm will be the exclusive distributor of the product in the United States, responsible for all sales, marketing, and clinical training.
About Injection Sclerotherapy:
Injection sclerotherapy is one of the primary methods for treating varicose veins, particularly for visible small to medium varicose veins, often known as spider and reticular veins, in the legs. In a sclerotherapy treatment, a therapeutic agent is injected into the vein to cause destruction of the vein, improving the overall aesthetic appearance. These veins are often red or blue, are close to the surface of the skin and they can look like tree branches or spider webs with their short jagged lines, and are typically found on the legs. Patients will typically undergo two to four minimally invasive in-office procedures without anesthesia lasting less than an hour.
According to the American College of Phlebology, up to 50% of women over the age of 18 may be affected by varicose veins. Current treatment options for varicose veins include various lasers, surgery, and sclerotherapy with hypertonic saline or other drugs. The American Society of Aesthetic Plastic Surgery reported that approximately 559,000 sclerotherapy procedures and about 158,000 laser vein removal procedures were performed in 2006. Some of the current laser treatments and sclerotherapy products in the U.S. may be associated with significant discomfort, which may discourage patients from seeking treatment. Currently, many women who are affected by this condition do not seek treatment, but many more might choose to seek treatment if a less painful alternative were available. The rate of treatment in Europe, where Aethoxysklerol is the leading sclerotherapy agent, is substantially higher than in the United States.
Aethoxysklerol is an injectable sclerosing solution which was developed by Kreussler in the early 1960's and has been used safely and effectively as the leading sclerotherapy injectable agent outside of the United States for over 40 years. It is approved broadly outside of the United States in various concentrations for visible small to medium varicose veins, such as spider and reticular veins, and for larger varicose veins. During the last two decades, Aethoxysklerol has been used in over 35-40 million patients, with several million patients undergoing treatment with this therapy each year. BioForm believes the key advantages of Aethoxysklerol are the fact that its active ingredient has anesthetic properties and its low incidence of adverse events, such as necrosis and hyperpigmentation.
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a privately-held medical aesthetics company headquartered in San Mateo, California. BioForm is dedicated to bringing doctors and their patients safe and effective products for use in the dermatology, plastic surgery and ENT markets. BioForm's products include Radiesse(R), a long-lasting filler for use in facial aesthetics and vocal fold insufficiency, and Coaptite(R) for treating female stress urinary incontinence which is marketed through a partnership with Boston Scientific Corporation. BioForm has licensed U.S. marketing rights to Aethoxysklerol(R), the worldwide leading sclerotherapy agent, which is currently being evaluated in a Phase III clinical trial. BioForm has also licensed BioGlue, a new surgical adhesive product for plastic surgery applications, which is being developed in a partnership with CryoLife, Inc. BioForm's website address is http://www.bioformmedical.com
Kreussler is an independent family-owned pharmaceutical and chemical company founded in 1912 by Christian Kreussler and situated in Wiesbaden, Germany. With 180 employees from 11 nations, its "Kreussler Pharma Division" develops, manufactures and markets worldwide drugs, cosmetics and devices especially for mouth and throat diseases, pain and sports diseases and vein therapy. In the field of phlebology Kreussler Pharma has developed "Aethoxysklerol(TM)", a range of sclerosing agents marketed in more than 50 countries for ambulatory, non-surgical injection treatment of varicose veins of different diameters, haemorrhoids and oesophageal varices, without additional local anaesthetics. In this sector Kreussler Pharma is seen to be the world market leader. This reputation is supported by an important clinical research program. Furthermore, the "Kreussler Textile Chemistry Division" focuses on the development, production and international marketing of special products in the field of professional laundry and textile care.
CONTACT: Adam Gridley
Vice President, Corporate Development
BioForm Medical, Inc.
Dr. Stephan Travers
011 49-611-92 71-172
Chemische Fabrik KREUSSLER & Co. GmbH
BioForm Medical, Inc.