Genzyme Corporation has filed for approval to market Synvisc (hylan G-F 20) in Japan for the treatment of pain from osteoarthritis. Synvisc is currently approved for use in the United States, Europe and 60 countries around the world.
"The filing to market Synvisc in Japan is an important milestone in further expanding the Synvisc franchise," said Ann Merrifield, president of Genzyme Biosurgery, the division of Genzyme Corp. that manufactures and distributes Synvisc. "Today, Japan represents an approximately $300 million market and provides a tremendous opportunity in which to promote Synvisc's unique benefits to patients."
The filing was made with the Japanese Ministry of Health, Labour and Welfare (MHLW) and product launch could take place in early to mid 2006.
Synvisc has been used to treat more than 2.5 million patients worldwide. It is Genzyme Corporation's third largest product, with worldwide end user sales expected to be between $262 and $284 million in 2003.
In addition to the filing in Japan, Genzyme recently received U.S. Food and Drug Administration (FDA) approval to begin a pivotal clinical trial in the U.S. for Synvisc in the hip. The trial is expected to enroll its first patient later this fall. In the European Union, Synvisc is already approved to treat pain due to osteoarthritis (OA) of the knee and hip. Additionally, clinical trials of Synvisc in the shoulder and ankle are anticipated to begin in the EU by the end of 2003.
"Genzyme is excited to begin a U.S. study of Synvisc in the hip, as there is currently no viscosupplementation product on the U.S. market shown to relieve OA pain in joints other than the knee," added Merrifield.
Synvisc is the largest selling viscosupplementation product in the United States and Canada for the treatment of pain due to osteoarthritis of the knee. Viscosupplementation is endorsed by the American College of Rheumatology as a standard of care in the treatment of OA of the knee.