Country's largest drug maker Dr Reddy's Laboratories is set to take its complex generic drug Fondaparinux sodium injection to Canada and two other emerging markets.
According to a statement by Alchemia Ltd, an Australian pharmaceutical company which has marketing tie up with the city-based drug maker, Dr Reddy's is expected to file for approval in up to four additional territories in 2014.
"The company (Alchemia) also expects Dr Reddy's to launch Fondaparinux in Canada in the coming months. Dr Reddy's has informed Alchemia that it has already received a notice of compliance from Health Canada for 2.5 mg, 5 mg, 7.5 mg and 10 mg strengths, which are sufficient to address the whole Fondaparinux market in Canada," the ASX-listed company said.
"In addition, the company is pleased to note that Dr Reddy's has filed generic applications for Fondaparinux with local regulatory authorities in two additional emerging markets," the statement said. When contacted, a DRL spokesperson said they will not be able to reveal the time of launch until everything is finalised.
In July 2010, Dr Reddy's said it signed an agreement with Alchemia and as per the agreement, Dr Reddy's will pay to Alchemia a royalty on sales at an agreed proportion. Dr Reddy's will have the option to market the drug itself or enter into agreements with third parties.
Fondparinux is used for treatment and prevention of deep vein thrombosis and is sold under the brand name Arixtra by GlaxoSmithKline. Dr Reddy's will manufacture the drug under licence using a patented process developed by Alchemia.
According to 2013 annual report of Alchemia, the net sales of Fondaparinux by Dr Reddy's were a total of USD 45.3 million resulting in a total profit share due to Alchemia of USD 9.6 million for the year.
Dr Reddy's launched Fondaparinux in Indian market in April this year, the first territory outside of the US, and subsequently DRL received approval it for sale in Canada.
With regard to the potential approval of Fondaparinux in Europe, Dr Reddy's has informed Alchemia that it has decided to conduct additional technical work and resubmit its application based on feedback from European regulators, which could result in an EU approval in late 2014 or 2015 based upon successful completion of the additional work, Alchemia said.