After US, Dr Reddy’s eyes Europe for Arixtra play

Dr Reddy’s Laboratories is looking to take its limited-competition candidate fondaparinux sodium — generic Arixtra — to the European market.

The company recently tapped the US market with the drug, used for treating and preventing deep vein thrombosis.

Arixtra, which is said to be difficult to manufacture by me-too competition, is estimated to have recorded $340 million in sales in the US during the 12 months ended March.

According to sources, the drug will come out of data exclusivity framework in Europe in March 2012, allowing generics makers to file for approvals.

“Our filing plans are aligned with the expiry of data exclusivity in Europe,” a DRL spokesman told DNA.

The official refused to indicate any schedule for the filings.
Sources, however, said it could take 15-24 months to get an approval.

According to European regulations, data exclusivity guarantees additional market protection for innovator pharmaceuticals by preventing health authorities from accepting applications for generic medicines during the period of exclusivity.

Incidentally, DRL was granted an approval to market the generic Arixtra in the US market by the Food and Drug Administration in July this year though it had submitted its abbreviated new drug application on fondaparinux in March 2009 and it was accepted for review in May 2009. Where an approval was expected in about six months, it took the authorities around 26 months to give a go-ahead. 

For the US market, Dr Reddy’s had entered into an agreement with Brisbane, Australia-based Alchemia for jointly tapping the potential of the drug. Under the terms of the agreement, DRL was to manufacture fondaparinux using a patented process developed by Alchemia.

It is not clear if the terms of that agreement would be extended to the European market in case DRL gets to take the drug there.    

After US, Dr Reddy’s eyes Europe for Arixtra play
Sources said fondaparinux is an interesting candidate to be taken to Europe, considering the complexity involved in manufacturing the product.

“Definitely, there are several entry barriers in developing the product. There are about 50 different stages in manufacturing fonda. The process is equally complex. It is not an easy task for others to quickly copy the development. So, any company with a developed process has an edge over others and that would help Dr Reddy’s in tapping the European market,” a source said.