Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration

BRISBANE, Australia--(Business Wire)--
Australian drug developer, Alchemia Limited (ASX:ACL), today announced that its
global manufacturing and U.S. marketing partner Dr Reddy`s Laboratories
(NYSE:RDY) has received notice of acceptance of its Abbreviated New Drug
Application (ANDA) from the United States Food and Drug Administration (FDA) for
Fondaparinux Sodium.

Dr Reddy`s filed the ANDA in March 2009 and this notice of acceptance indicates
that the ANDA will now enter a period of formal review. Being the first generic
version of fondaparinux, the application has been marked for priority review
under FDA`s Generic Initiative for Value and Efficiency (the GIVE initiative).
First generic products, for which there are no blocking patents or exclusivity
protections on the reference listed drug, are identified at the time of
submission for expedited review.

The manufacturing process for fondaparinux used by Dr Reddy`s utilizes a novel,
synthetic pathway developed by Alchemia.

About Abbreviated New Drug Applications (ANDA)

According to the FDA`s Center for Drug Evaluation and Research (CDER), an ANDA
contains data that provides for the review and ultimate approval of a generic
drug product. Once approved, an applicant may manufacture and market the generic
drug product as an alternative to the branded drug. A generic drug product is
comparable to an innovator drug product in dosage form, strength, route of
administration, quality, performance characteristics and intended use. Generic
drug applications are termed "abbreviated" because they are generally not
required to include preclinical and clinical data to establish safety and
effectiveness. Instead, generic applicants must scientifically demonstrate that
their product is equivalent to the branded drug.

About Alchemia Limited - www.alchemia.com.au

Alchemia is a drug discovery and development company founded on its chemistry
expertise. The Company`s lead program is fondaparinux (synthetic heparin, a
generic version of GlaxoSmithKline`s Arixtra®) which is expected to generate
near term revenues for the company and is partnered with Dr Reddy`s Laboratories
Inc. for the U.S. market. Alchemia`s pipeline of assets is built on two platform
technologies: HyACT® (targeted cancer delivery) and VASTTM (drug discovery).
HA-irinotecan, for the treatment of colorectal cancer, recently achieved
positive Phase II clinical trial results.

Arixtra® is a registered trademark of GlaxoSmithKline.
VASTTM and HyACT® are trademarks of Alchemia and Alchemia Oncology.

Alchemia Limited
Dr Pete Smith, +61 7 33400200
Chief Executive Officer
or
Blueprint Life Science Group
Ms Remy Bernarda, + 1-415-375-3340 ext. 2022
rbernarda@bplifescience.com

Copyright Business Wire 2009