Emisphere Technologies and Alchemia to Research an Oral Formulation of Fondaparinux with Eligen® Technology
March 18 2010 - 8:30AM
Business Wire
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.
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