Stellar Pharmaceuticals Inc., a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announced that it has received the CE Mark for its NeoVisc Single Dose viscosupplement therapy, denoting conformity with European standards for safety. Receipt of the CE Mark allows the Company to market both its NeoVisc Triple Dose (3 x 2mL) and its Single Dose (1 x 6mL) products to countries in the European Union.
NeoVisc Single Dose is a 6mL pre-filled syringe of sterile 1.0% sodium hyaluronate solution used for the temporary replacement of synovial fluid in osteoarthritic knee joints. The product is administered in a single dose directly into the affected knee joint. Both the NeoVisc Single Dose (1 x 6mL) and the original NeoVisc (3 x 2mL) are now available for sale in European Union.
Osteoarthritis (OA) affects approximately 85 million people in the G7 countries and is expected to increase to 122 million by 2017. In terms of market size, researchers have estimated the value of the global OA therapeutics market to be valued at approximately $5 billion in 2009. The value of this market is expected to reach $9.6 billion by 2017. This significant growth in market size is primarily attributed to the high incidence and prevalence of the disease and the high prescription rates of the currently approved products.
Arnold Tenney, Stellar's president and CEO, stated, “This approval is a significant milestone in Stellar's global licensing strategy, as OA is the most common joint disease, affecting the vast majority of the population by age 70. Recent census publications indicate that Europe has 19 of the world's 20 oldest countries in terms of population age. With the NeoVisc Triple Dose product already being sold throughout Eastern Europe, the addition of the NeoVisc Single Dose product provides flexibility and greater access for our distributors in these large, growing markets. In addition, the Company is actively searching for new licensing opportunities in other large markets such as the United States, China and Japan.”