Biotech Values

[BioSpecialist]

Strong Growth for Arixtra

Last quarter in brackets

US US$38 ($US32m) up 19%
Europe US$28m (US$22m) up 27%
RoW US$4m (US$4m)

Good growth in a quarter again.

gsk's comments:

New growth drivers
Arixtra, for deep vein thrombosis and pulmonary embolism, delivered strong growth with sales up 70% to
£35 million. Sales grew in Europe (up 33% to £14 million) following approval last year for the treatment of
specific acute coronary syndromes (ACS). In the USA, GSK is in on-going discussions with the FDA
regarding a potential ACS indication.


27 March 2008
Alchemia’s generic fondaparinux a potential beneficiary of heparin product recalls.

The company has received numerous enquiries from investors regarding the recent publicity concerning patient reactions to heparins and the recall of those products in local and overseas markets. Adverse events such as anaphylaxis (acute allergic reactions) and low blood pressure have been reported in hundreds of patients who have received unfractionated heparin in the US. The FDA has also reported over 20 deaths, several linked to the adverse heparin reaction.
The heparin market is comprised of three classes of products: unfractionated heparins (heparin), an animal derived compound; Low Molecular Weight Heparins (LMWH) e.g. Lovenox®, which are modified forms of unfractionated heparin and are, therefore, also animal derived; and the synthetic heparin (fondaparinux) Arixtra®, which is a completely synthetic compound. Whilst the contamination currently affects unfractionated heparin only, it should be noted LMWH’s are also under investigation. Fondaparinux is the only drug in the heparin market which is not animal derived being completely synthetic, comprising a single purified chemical substance.
Alchemia’s CEO, Dr Pete Smith stated that in numerous studies it has been found that Arixtra® (fondaparinux) offers superior safety and efficacy over both unfractionated heparin and LMWH’s without the possibility of contamination. “We would expect that GSK’s sales of Arixtra® will benefit from the adverse publicity surrounding its competitors and that this will increase the sales potential of our generic version.” Dr Smith added, “Development of our product remains on track with the potential for approval before the end of 2008 and sales commencing early in 2009.”

The global heparin market is currently worth approximately $US4.6 billion of which $US400 million is unfractionated heparin, about $US4 billion is LMWH, with the only currently available synthetic heparin, Arixtra®, earning about $US200 million in 2007 an increase of 87% over 2006 sales.




Alchemia has the only generic version of Arixtra
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