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Pharming net loss wider; reiterates 'progress' on regulatory progress


Published :
Fri, 20 Jul 2007 06:43
By : Agencies
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AMSTERDAM (Thomson Financial) - Pharming Group NV reported a wider net loss for the first half of 2007 while reiterating previous statements about the 'important progress' with ongoing regulatory processes for its lead product, Rhucin.

The pharmaceutical group reported a net loss of 11.3 mln eur in the first half, verses 8.1 mln eur in the same period a year earlier and on the high end of analysts' expectations.

Pharming said its cash position as of June 30 was 19.1 mln eur, down from 31 mln at the end of 2006 and slightly ahead of what some analysts predicted.

Total costs and expenses for the half reached 10.7 mln eur, compared to 8.1 mln eur in the same period a year ago while total equity was 39.9 mln on June 30, versus 49.8 mln on December 31, 2006.

The group reported revenues of 0.4 mln eur compared to less than 0.2 mln eur for the full year of 2006.

Regarding the regulatory process for Rhucin, a protein designed to combat a rare condition that causes swelling, Pharming said it has submitted answers to a list of questions from the European Medicines Evaluation Authority (EMEA) in the review process for the Market Authorization Application for the drug.

CEO Francis Pinto said that the filing, coupled with the EMEA's recent approval of Pharming's manufacturing facilities 'give us confidence that we will be able to bring this product to market in the near future.'

Pharming has previously said it expects to hear the EMEA's opinion on the drug in the second half of this year.

The company reiterated that it is confident that it has demonstrated the safety of another product, a dietary supplement called Lactoferrin, and that the US Food and Drug Administration (FDA) are reviewing the Pharming's request to obtain Generally Recognized as Safe status for the product.

They expect communication from the FDA on the next steps in the third quarter and said they expect a final opinion from the FDA on Lactoferrin later this year.

Dave van Ginhoven, dave.vanginhoven@thomson.com

dvg/hjp

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Copyright AFX News Limited 2007. All rights reserved.

The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.




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