Piramal Healthcare (PHL), on Wednesday, said it had received European regulatory approval to sell its bio-orthopedic product for cartilage repair, BST-CarGel, in European Union countries.
Addressing a press conference, Swati Piramal, Director, Piramal Healthcare, said, “with the European CE mark approval, we can start selling BST-CarGel in countries such as the U.K., Germany, France, Spain and Italy. We intend to start from the fourth quarter of calendar 2012. We have applied for regulatory approval in Canada, India and South America. Europe being the biotherapeutic leader globally, we will seek approval to sell in India after Europe but cannot predict the time-line.”
“BST-CarGel requires one surgery and it fills a void in the cartilage repair market. It is a liquid thermogel and helps regenerate damaged tissue. The competing technology is very expensive and requires knee replacement and a considerable recovery period.” PHL had invested in BioSyntech Technologies Inc (BST), Canada, in 2006 and bought it in 2010 for Canadian $3.9 million gaining access to BST's product portfolio.
In a statement, Ajay Piramal, Chairman, Piramal Group, said, “BST-CarGel provides us with a superior way to address significant unmet medical needs in the global knee cartilage repair market.”Ms. Piramal said PHL would be the patent holder of the product globally till 2020-21.
The company intends to market the product in India and Canada but will decide by October 2012 whether to market on its own or in partnership with other companies in other markets.
Ms. Piramal said the future strategy for PHL was to have more products in the global market. PHL is now working on another version of the product with a longer shelf life to be introduced in the U.S. market. “We will make the product from our Toronto facility and that will be useful for joints other than the knee.”