Dear Shareholder,
Thanks for your email. I can certainly understand your frustration with the shareprice and the lack of any concrete news on progress to support the shareprice in these turbulent markets. The medium term driver of the share price is the filing for approval and marketing of fondaparinux and, regrettably, we are unable, under the terms of our Marketing Agreement with Dr Reddy's, to give detailed updates on that project. These are for reasons of commercial significance - we do not want GSK to be in a position to launch an Authorized Generic. To make an AG worthwhile GSK would need to know when we will be filing the ANDA for approval. We have communicated that we expect fondaparinux to be approved in H1 2009 and that timeline remains. The FDA is mandated to review generic applications within 180days - it is currently managing an average of 218 days - and that should give you a reasonable steer as to the timing on the filing. Once filed, we will be free to communicate much more openly.
All I can say is that this project is progressing very well - we have had some technical issues that have resulted in a delay, but those issues are all behind us and, apart from the review time at the FDA, we have great certainly on the timing of the project. I can't say more without breaching disclosure regulations.
The projects on which we are working are lengthy and there are often periods of little 'news', but I can assure you that we are making significant progress on multiple fronts. My primary responsibility is to increase shareholder value and I asure you that we are working hard to deliver.
Thank you for getting in contact and please feel free to phone or email if you have any comments or need clarification.
Best regards
Pete
...........................................
Pete Smith MA PhD
Chief Executive Officer
Alchemia Limited
T: +61 (0)7 3340 0213
M: +61 (0)409 936 106
F: +61 (0)7 3340 0222
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