Alchemia Limited, (ACL), has been granted a new patent in the US that further enhances the protection of the proprietary process used for the manufacture of fondaparinux sodium, a drug used for the prevention and treatment of venous blood clots (DVT). Alchemia’s fondaparinux was approved for sale in the US in July 2011 where it is marketed under license by Dr Reddy’s Laboratories Inc. Patent 8,114,970, entitled “Synthetic Heparin Monosaccharides” by Seifert et al broadly protects critical building blocks that are used in the Alchemia process for manufacturing fondaparinux. The monosaccharide (single sugar) building blocks enable the efficient synthesis of fondaparinux which is a pentasaccharide (five sugar) molecule.
Commenting on the granting of the patent, Michael West, Alchemia’s VP of Intellectual Property, said, “This is the second of four patent applications in the US for the fondaparinux process that have proceeded to grant. We are very happy with the robust protection that we are building around our manufacturing process.” Arixtra, the branded version of fondaparinux, has been off patent since 2002 in the US meaning that the process originally developed for its manufacture has been open for anyone to use for nearly a decade. “The lack of any other ANDA approved generic competitors is testament to the complexity of the original synthetic process used for fondaparinux. It is also underlines the importance of having protection for Alchemia’s improved process” added Pete Smith, Alchemia’s CEO.
Alchemia is a drug discovery and development Company founded on its chemistry expertise. The Company’s lead drug, fondaparinux (a generic version of GlaxoSmithKline’s Arixtra®, a synthetic anticoagulant mainly used for the prevention of deep vein thrombosis), was approved and launched in July 2011 in the U.S. by Alchemia’s marketing partner Dr Reddy’s Laboratories. Alchemia’s pipeline of assets is built on two platform technologies: HyACT® (targeted cancer delivery) and VAST® (drug discovery). The primary objective of the HyACT® technology is to develop a new generation of anti-cancer drugs which demonstrates better efficacy. The lead product from the HyACT® platform is HA-Irinotecan which is currently in a pivotal Phase III clinical trial that commenced recruitment in January 2012.