Piramal gets EU nod for orthopaedic product BST-CarGel

Geetanjali Shukla

Piramal Healthcare has received European Union regulatory approval for its bio-orthopaedic product, BST-CarGel, used for knee cartilage repair. BST-CarGel is a biodegradable scaffolding which helps regenerate cartilage. It is minimally invasive -a one-stage application that can be preformed with the help of an arthroscope- and can become a cost effective alternative to knee replacement surgeries.

The EU approval means that the company can market the product (by the end of this year) in all countries in the European Union and opens up the $200 million market for the company. But more importantly, the European approval will serve as a basis to obtain similar such approvals from other geographies like the Middle East, South America, and Asia Pacific, and countries like India.

BST-CarGel is a product of BioSyntech Technologies, a Montreal-based company. BioSyntech was partially acquired by Piramal in 2006. In 2010, Piramal acquired the assets relating to BST-CarGel from BioSyntech, when the latter was faced with insolvency.

 "BST-CarGel is a novel thermogel liquid scaffold that is first mixed with auotologous whole blood and then implanted into a debrided cartilage defect prepared with bone marrow stimulation. BST-CarGel treated carilage provided voluminous and bio-degradeable scaffolding for cartilage re-generation by stem cells that migrate from the bone marrow," the company said in a statement.

The European regulatory approval is a step in the right direction for the company, which after selling its formulations business to Abbot in 2010 was looking to focus on the drug discovery business. The company has 14 drugs in the pipeline with its lead molecules in cancer, and hopes that in the next two to four years many of its drugs will go to market. It recently announced that it will up its R&D spend for financial year 2013 as it takes two of its cancer molecules to the second phase of clinical trials.

The company has over the last year has brought in some big names to strengthen its drug discovery and go-to-market plans. Last year, the company also roped in Alan Hatfield, former global clinical program head for leukemia at Novartis AG and medical director at Lilly. The company has also brought in eminent persons on its scientific advisory board like Dr. William Jenkins, Ex-head of Clinical Development & Regulatory Affairs at Novartis and Fellow of the Royal College of Physicians, UK; Prof. Goverdhan Mehta, Fellow of Royal Society; and Prof Bob Chaudhari, ex-senior research manager at Novartis and principal inventor for 15 granted patents.

The company has also quite astutely balanced its drug discovery programme by focussing one risky area at a time - like cancer - and offsetting the risk by focussing on relatively high success areas like anti-inflammation and anti-infectives.

Post the European regulatory nod for BST-CarGel - which hopes to address the unmet needs in the knee cartilage repair market- the company is now looking to focus on other joint products. Dr. Swati Piramal, director, Piramal Healthcare, on the sidelines of the press briefing announcing the regulatory approval, said, "There are other joints which have problems like the ankle and the shoulder, for which there are no technologies available today. Some research was being done on ankle and shoulder joints at BioSyntech even before we took over. We will now pay attention to that as well."

According to Piramal these studies are in the research and pre-clinical trial stages.