Emisphere Technologies And Alchemia To Research An Oral Formulation Of Fondaparinux With Eligen(R) Technology

Main Category: Blood / Hematology
Article Date: 21 Mar 2010 - 0:00 PDT


Emisphere Technologies, Inc. (OTCBB:EMIS) and Alchemia Ltd. (ASX:ACL) announced that they are joining efforts to develop an oral formulation of the anti-coagulant drug fondaparinux with Emisphere's Eligen® Technology.

Emisphere's broad-based drug delivery platform, known as the Eligen® Technology, uses proprietary, synthetic carriers to enhance the oral bioavailability of a drug without altering its chemical form or biological activity. Fondaparinux, an anti-coagulant used for the prevention of deep vein thrombosis, is marketed in injectable form as Arixtra® by GlaxoSmithKline. Arixtra has been off patent since 2002 but, due to the complexity of its synthesis, there is currently no approved generic or alternative source of commercial scale active pharmaceutical ingredient ("API"). Alchemia has developed a novel, patent protected, synthesis for the manufacture of fondaparinux at commercial scale. In March 2009, Alchemia's manufacturing and U.S. marketing partner, Dr Reddy's Laboratories (NYSE: RDY) submitted an ANDA to the U.S. FDA for a generic version of the injectable form of fondaparinux.

"An oral formulation of fondaparinux could dramatically increase the market potential for fondaparinux. Based on what we know from our experience with other chemically-related anti-coagulants, the profile of fondaparinux should fit very well with the Eligen® Technology given its half life and safety profile. Although developing an oral formulation of an injectable compound is always challenging, this project could produce substantial benefits for the medical community. The combination of Emisphere's delivery technology and Alchemia's fondaparinux may ultimately allow us to bring an oral anti-coagulant to market in an accelerated fashion," said Michael Novinski, President and Chief Executive Officer of Emisphere Technologies.

"We have already seen preclinical data suggesting that enhanced levels of oral absorption can be achieved for fondaparinux. If we can successfully optimize the dose formulated with the Eligen® Technology from Emisphere it would open up a host of medically and commercially compelling opportunities for fondaparinux," said Pete Smith, CEO of Alchemia Ltd. "We will initially evaluate a number of different formulations in order to optimize oral bioavailability and pharmacokinetics, with the aim of then rapidly moving into human clinical studies."

Source
Emisphere Technologies, Inc.
And Alchemia Limited

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