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[posting]36769096[/posting]Alchemia hat noch neben Fondaparinux auch HyCamp (das demnächst Phase III starten wird) auf lager .
HyCamp (behandlung von metastatisch kolorektalen Krebs) das zuvor sehr gute Phase II Daten geliefert hat soll demnächst Phase III starten ,es wird nur eine Phase III Studie benötigt um in USA den Zulassungsantrag zu stellen .


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Fondaparinux

Global sales of fondaparinux reported by GSK for the 2008 CY were US$315m, up +57.5% over 2007 CY sales of
US$200m. Alchemia anticipates that its US marketing partner Dr Reddy’s Inc. will take a significant share of the
market soon after launch. Due to the complexity of the synthesis of fondaparinux it is unlikely that there will be
other generic competitors. Alchemia’s position was enhanced in October 2008 by the granting of a key US patent
on its manufacturing process.


Oncology

Alchemia’s oncology programs including HA-irinotecan are all based on its HyACT® technology for targeting
cancer therapies to tumours. Our preclinical focus over the past six months has been on confirming the ability of
HyACT® to enhance the activity of anti-cancer antibodies. Studies showing that the HyACT® platform can
enhance the activity of Avastin® (Genentech/Roche) were repeated successfully.



http://www.alchemia.com.au/IRM/Company/ShowPage.aspx?CPID=13…

“The advancement of HA-Irinotecan into a Phase III trial makes Alchemia one of the few biotech companies in Australia that has two late-stage assets in its drug development portfolio – the other being generic fondaparinux, a synthetic heparin which remains on track for approval and launch in 2009.” stated Pete Smith, Ph.D., Chief Executive Officer of Alchemia. “We previously announced that the FDA requires only one pivotal trial for registration of HA-Irinotecan via the 505(b)(2) process, as opposed to the usual two trials required in a full New Drug Application. We continue to explore the best partnering opportunities for this product.”
 
aus der Diskussion: Alchemia Limited -- Gelegenheit des Jahres
Autor (Datum des Eintrages): BrauchGeld  (15.03.09 21:05:38)
Beitrag: 36 von 83 (ID:36770853)
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