BIOIBERICA would extend the right to use its CTD dossier for registration of Cartisorb® (Glucosamine Sulfate sachets) as a branded generic drug (to be marketed under Cartisorb® brand name or other brand name) on a local level.

GS (glucosamine sulphate) acts on cartilage metabolism, increasing proteoglycan synthesis and decreasing aggrecanase activity (aggrecanases 1 and 2) and protease MMP-2, MMP-3, MMP-9 and MMP-13.

The global osteoarthritis market is forecast to grow steadily and will reach $7 billion by 2015.

Since the withdrawal of Vioxx from the global market due to its cardiovascular adverse effect and the increased awareness of NSAIDs severe gastrointestinal effects, doctors are seeking for safe alternatives to treat osteoarthritic patients long term. Market growth is coming come from expanded use of Chondroprotective molecules such as Glucosamine. Apart from a high safety profile, Glucoamine  has proven a symptomatic efficacy as well as a disease modifying effect in osteoarthritis.

GS has also been shown to reduce pro-inflammatory factors as PGE2, IL-1 and inhibit the generation of superoxide radicals. Glucosamine sulphate significantly inhibited NF-kappa-B activity in a dose-dependent manner.
 

Preregistration

Bioiberica’s goal is to actively seek a partnership with a local or regional pharmaceutical company which considers musculoskeletal diseases a strategic therapeutic field. Ideally the company should already have rheumatologists and orthopedists as its main targets and it should aim to enlarge its portfolio of products for Osteoarthritis.