Anika Announces Regulatory Approval for MONOVISC in India

Anika Therapeutics Inc. announced that regulatory authorities in India granted approval to MONOVISC, its single-injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints. MONOVISC is commercially available in the United States, Canada, and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months.
 
“Expanding our global commercial footprint is one of our key strategic pillars of growth, and the approval of MONOVISC in India is a proof point for our ability to execute against the benchmarks we define each year,” said Charles H. Sherwood, Ph.D., president and CEO of Anika Therapeutics. “There is a growing demand for non-invasive, long-acting treatments for osteoarthritis in emerging countries such as India where knee replacement surgery is often the last option or not an option at all, due to limited medical resources outside major cities and high costs of surgery and postsurgical care. With its ability to safely relieve pain for up to six months with fewer office visits, lower treatment costs and no downtime after treatment, MONOVISC is poised to be well-received by physicians and patients in India.”
 
The global expansion of MONOVISC is the primary international orthobiologics revenue driver for Anika, and India represents a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Modi-Mundipharma Pvt. Ltd. (MMP) to market MONOVISC in India. MMP is a multinational pharmaceutical company with a significant focus on pain management. Utilizing its large, dedicated sales force, MMP will be able to introduce MONOVISC to a broad range of physicians that treat a substantial number of patients suffering from the symptoms of osteoarthritis.
 
MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin.
 
Anika Therapeutics is a global, integrated orthopedic medicines company based in Bedford, Mass. The company has more than two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.