Pharming H1 net loss wider; restates 'progress' on regulatory progress

Pharming H1 net loss wider; restates 'progress' on regulatory progress - UPDATE

	Published : Fri, 20 Jul 2007 07:16 By : Agencies Print this Story

(Updating with more detail on products, future plans, inventories, DNage revenues)

AMSTERDAM (Thomson Financial) - Pharming Group NV reported a wider net loss for the first half of 2007 and reiterated 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 at 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 had 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.

Chief executive 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 while still predicting that placebo-controlled randomised clinical trials for Rhucin in the US will be finalized in the second half of the year.

Pharming referred back to the fact that rhC1NH, the Rhucin protein, has received orphan drug status from the EMEA for a different use, the treatment of organ transplant complications known as Delayed Graft Function (DCF), the company said it is 'well underway' to starting the first clinical studies in the second half of 2007.

The company reiterated 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) is reviewing the Pharming's request to obtain Generally Recognised 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.

Regarding its efforts to develop recombinant human fibrogin as a pharmaceutical product for bleeding disorders and medical device applications in partnership with third parties, the company said it expects to provide further development details in the second half.

On the financial front, Pharming said it has been able to keep costs in line and expects to strengthen its financial position later in the year, either through commercial agreements or a financial transaction, or a combination of both.

This will allow for an effective launch for Rhucin and the expansion of clinical programmes to develop the protein for other indications, according to Pharming's statement.

Inventories of Pharming's products have increased to a value of roughly 11 mln eur as of June 30 in anticipation of commercial launch, the company said, adding that the finished product, bulk-purified product and frozen milk on inventory have expiration dates well beyond the expected date of use.

Although the company has not begun selling its products, it did report revenue growth it said was due to increased subsidies and grants related to its DNage subsidiary.

DNage is preparing its first clinical studies in the field of aging-related illness for next year and will conduct studies involving a product called Prodarsan in a sub-group of patients suffering from premature aging.

Dave van Ginhoven, dave.vanginhoven@thomson.com

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Pharming H1 net loss wider; restates 'progress' on regulatory progress - UPDATE