Replies to post #60380 on Biotech Values

[BioSpecialist]

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