Emisphere Technologies, Inc. (OTCBB:EMIS) and Alchemia Ltd. (ASX:ACL)
today 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.”
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on the unique and
improved delivery of therapeutic molecules or nutritional supplements
using its proprietary Eligen® Technology. The Eligen®
Technology can be applied to the oral route of administration as well as
other delivery pathways such as buccal, rectal, inhalation,
intra-vaginal or transdermal. The company’s website is www.emisphere.com.
About Alchemia Limited
Alchemia is a drug discovery and development Company founded on its
chemistry expertise. The Company’s lead program is fondaparinux (a
generic version of GlaxoSmithKline’s Arixtra®, a synthetic
anticoagulant mainly used for the prevention of deep vein thrombosis).
Fondaparinux is expected to generate positive cash-flows for the Company
commencing in the second half of calendar 2010. Alchemia is also
developing HA-Irinotecan, the most advanced product employing its HyACT®
tumor targeting technology. A pivotal Phase III study of HA-Irinotecan
in metastatic colorectal cancer patients is currently being initiated.
For further details see www.alchemia.com.au
Safe Harbor Statement Regarding
Forward-Looking Statements
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or
potential outcomes of research collaborations or clinical trials, any
market that might develop for any of Emisphere's product candidates and
the sufficiency of Emisphere's cash and other capital resources) are
forward-looking statements that involve risks and uncertainties,
including, but not limited to, the likelihood that future research will
prove successful, the likelihood that any product in the research
pipeline will receive regulatory approval in the United States or
abroad, the ability of Emisphere and/or its partners to develop,
manufacture and commercialize products using Emisphere's drug delivery
technology, Emisphere's ability to fund such efforts with or without
partners, and other risks and uncertainties detailed in Emisphere's
filings with the Securities and Exchange Commission, including those
factors discussed under the caption "Risk Factors" in Emisphere's Annual
Report on Form 10-K for the fiscal year ended December 31, 2008 (file
no. 000-17758)
filed on March 16, 2009 and as amended on Form 10-K/A as filed on April
30, 2009, and our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2009 as filed on November 9, 2009.
