Commercial rights to Hyalgan transitioned from Sanofi back to Fidia, the brand's owner and manufacturer
Wholly-owned subsidiary, Fidia Pharma USA Inc, engages Interpace BioPharma, LLC. to handle distribution and promotional support
PARSIPPANY, N.J., Sept. 26, 2011 /PRNewswire/ -- Fidia Farmaceutici S.p.A. ("Fidia") announced today that it has assumed responsibility for distributing and promoting the osteoarthritis (OA) treatment, Hyalgan (sodium hyaluronate), in the United States through its wholly-owned subsidiary, Fidia Pharma USA Inc. ("Fidia USA"). Fidia USA has engaged Interpace BioPharma, LLC. ("Interpace") to provide commercialization services to support Hyalgan.
Hyalgan was introduced in Italy in 1987. In 1997, Hyalgan became the first viscosupplementation product approved for marketing by the U.S. Food and Drug Administration. More than 38 million doses of Hyalgan have been administered worldwide since its introduction.(1) Hyalgan is indicated to relieve pain associated with osteoarthritis (OA) of the knee when simple analgesics like acetaminophen have failed.
"We are pleased to continue providing a treatment that has helped millions of patients worldwide who have suffered the debilitating effects of osteoarthritis," said Antonio Germani, CEO of Fidia Farmaceutici S.p.A. "Hyalgan has demonstrated its safety and efficacy in more than 90 clinical trials involving more than 13,000 patients. Our commitment is to provide our customers and patients the quality service they deserve, including reimbursement and patient assistance as well as patient education materials. Our goal is to see to it that Hyalgan remains a sustainable treatment of choice for patients with knee pain associated with OA," said Germani.
About Osteoarthritis (OA)
According to the Arthritis Foundation, 27 million Americans suffer from OA, which is common in all races and backgrounds. The condition usually appears after the age of 45 years. Men under age 55 years are more likely to have osteoarthritis than women in the same age range. After 55 years, women are more commonly affected. OA is a chronic condition characterized by the breakdown of the joint cartilage and synovial fluid, which acts as both as a lubricant and shock absorber for the knee joint. The breakdown of the cartilage and synovial fluid causes the bones to rub against each other, causing stiffness, pain and loss of movement in the joint. While there is no cure for OA, current disease management focuses on controlling joint pain and stiffness.
Hyalgan is based on natural hyaluronic acid which is structurally and chemically similar to hyaluronic acid that is present in the knees of healthy individuals. Hyaluronic acid is a vital natural component of the cartilage and synovial fluid of the knee joint.
"For many years, Hyalgan has served as an important therapeutic option for sufferers of osteoarthritis," said Dr. Frank Kane of Fidia Pharma Inc. "Its long-established safety and efficacy record has demonstrated its usefulness in relieving the pain of osteoarthritis in patients who do not get relief from simple analgesics, such as acetaminophen, or are unable to tolerate the side effects of non-steroidal anti-inflammatory agents," continued Kane.
The recommended treatment cycle for Hyalgan is five intra-articular injections given once a week for five weeks, although many patients receive significant pain relief after a three-injection regimen consisting of one injection per week for three weeks. Hyalgan will relieve pain in a many patients for up to six months. Hyalgan is only approved to relieve knee pain. The FDA has not evaluated Hylagan's safety and efficacy in other joints. Full prescribing information and important safety information for Hyalgan can be found at http://www.hyalgan.com.
About Fidia Farmaceutici S.p.A
Headquartered in Abano Terme, Northeast Italy, Fidia Farmaceutici S.p.A., has over 50 years of successful R&D and industry experience with biologically active molecules. As a model for international success, Fidia has focused its core business activities on hyaluronic acid and glycosaminoglycan derivates, developing and providing a wide range of products for various specialties. Fidia holds more than 960 patents on hyaluronic acid and its applications and its products are currently available in over 70 countries worldwide. Fidia's most important proprietary platform technology at a worldwide level is the chemical modification, development, and manufacturing of state-of-the-art pharmaceuticals and medical devices based on hyaluronan covering therapeutic categories such a Joint Care, Advanced Wound Care, and Aesthetic Dermatology.
Helping people stay healthy is Fidia's corporate commitment. For more information, visit www.fidiapharma.com.
About Interpace BioPharma, LLC.
Located in Parsippany, NJ, Interpace is a wholly owned subsidiary of PDI, Inc., a leading company that provides a wide range of commercialization services to the life science industry. Interpace provides marketing, sales, and product distribution support to manufacturers of pharmaceutical and biological drugs, medical devices and clinical diagnostics.
(1) Data on File, Fidia Farmaceutici S.p.A.
SOURCE: Fidia Farmaceutici S.p.A.