Lovenox 2x daily versus Arixtra 1x daily injection
Low Molecular Weight Heparin (LMWH)
Brands: Lovenox, Fragmin, Fraxiparin
Introduced : 1993
Source : Animal derived
Composition : Complex mixture
Delivery : 2x daily injections
Reduction in DVT : 67%
Activity : Factor II<Xa, others
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Fondaparinux
Brands : Arixtra
Introduced : 2002
Source : Synthetic
Composition : Single molecule
Delivery : 1x daily injection
Reduction in DVT : 85%
Activity : Factor Xa
A unique generic opportunity
Alchemia has the only known generic fondaparinux sodium
GSK’s synthetic process is complex and low-yielding
Alchemia has a superior, patented process
Completely synthetic –not animal derived
Low-molecular weight heparins e.g. Lovenox, are complex biological mixtures
Route to market via Abbreviated New Drug Application (ANDA)
Regulatory path for other generic heparins is not clear
FDA has rejected Momenta/Sandoz ANDA for generic Lovenox
Alchemia’s fondaparinux may be the first generic in the $4.5Bn heparin market
Generic copy of GlaxoSmithKline’s Arixtra®
Arixtra is gaining market share in $4.5Bn heparin market
Superior safety profile versus market leader Lovenox®
47% reduction in bleeding compared with Lovenox in ACS
Superior efficacy profile versus Lovenox
56% improvement in deep vein thrombosis (DVT) prophylaxis
New indications for Arixtra will drive future growth
Approvable letter for ACS indication 5 Feb 2007
ACS approved in EU September 2007
Highest recommendations from ECS, AHA and ACC
