synthetic heparin << ANDA filing
Fantastic news
Alchemia Limited( ACL.AX )
Marketcap : 25 million A$
Cash : 11 million A$
Price : 0,22 A$
Sydney - Friday - March 13: (RWE Australian Business News) -
Alchemia Ltd (ASX:ACL) today announced its global manufacturing and US
marketing partner, NYSE-listed Dr Reddy's Laboratories, had submitted an
Abbreviated New Drug Application (ANDA) with the United States Food and
Drug Administration (FDA) for Fondaparinux Sodium for Injection in
2.5mg, 5.0mg, 7.5mg and 10.0mg doses.
The application has been filed with a Paragraph II certification
indicating that there is no remaining patent listed for the drug.
Fondaparinux is marketed by GlaxoSmithKline under the brand name
Arixtra. It is an anticoagulant currently approved for a number of
indications including the treatment and prevention of deep vein
thrombosis (blood clots) in a number of medical settings such as
post-operative knee and hip surgery.
In 2008, global sales of Arixtra were $US315m (+58pc) and sales
in the US market were $US163m (+50pc).
"The filing of the ANDA is a major achievement for Alchemia. Of
all the drugs used in modern medicine, fondaparinux is one of the most
challenging molecules to synthesise, and we are proud to have
accomplished this feat with Dr Reddy's, our partner for its
manufacturing and commercialisation," said Dr Pete Smith, chief
executive of Alchemia.
"Whilst the key patents on Arixtra expired in 2002, no company
has filed for the approval of its generic until now, and we are not
aware of any other generic manufacturers currently capable of making
this molecule at commercial scale.
"Because we do not foresee the entry of other competitors in the
near term, we expect pricing, market share and profitability to remain
higher compared to a typical generic product."
