Dr. Reddy's Laboratories has purchased worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner, Alchemia Limited, for $17.5 million.

Fondaparinux is a generic version of the anticoagulant drug Arixtra, which is approved in the U.S. and Europe for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and is also indicated for the prevention of DVT after major surgery, such as knee and hip replacement. Fondaparinux is recommended by the American College of Chest Physicians and received the European Society of Cardiology’s highest recommendation for use in acute coronary syndrome. Fondaparinux is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale. Alchemia has granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture Fondaparinux until at least 2022.

The IP purchase comes on the heels of the receipt of a warning letter from the U.S. FDA relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.

Regarding the warning letter, Dr. Reddy’s chief executive officer, G V Prasad said, “We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated time frame of 15 days. We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority.”