UPDATE 2-Pharming says Rhucin study shows immunological safety
* Full immunological safety study part of regulatory filings
* Preparing filings outside U.S., EU
* Shares up 13.4 pct
(Adds analyst comments, shares)
AMSTERDAM, June 1 (Reuters) - Dutch biotechnology firm Pharming Group NV (PHAR.AS) said on Monday its lead product Rhucin has moved a step closer to regulatory filings for marketing approval after passing an interim analysis.
The company said the latest analysis showed that patients treated with Rhucin had not experienced a triggered immunological side-effect, such as the production of antibodies.
The EMEA has twice rejected Pharming's application to market Rhucin, which treats hereditary angioedema, characterised by acute attacks of painful swelling of the skin, intestine, mouth and throat.
Pharming has said it intends to refile an application for approval of Rhucin with the European Medicines Agency (EMEA) in September, while a filing with the U.S. Food and Drug Administration (FDA) would follow.
"Results of the presented interim analysis confirm the absence of immunological side-effects," Pharming said in a statement, adding it had presented the analysis at a workshop in Budapest.
Shares in Pharming rose in morning trade and at 0923 GMT were up 13.4 percent at 0.69 euros, to be the second-largest gainer in a positive Amsterdam market, outperforming a 2.7 percent rise in the Amsterdam AEX index .AEX.
"This gives more confidence to the story and confidence about the filings for Rhucin at the EMEA and FDA," AEK analyst Bernd Hilhorst said, adding that although it confirms earlier data it is still a minor step for the company.
"The major problem in Pharming are the financials," he said.
Hilhorst anticipates Pharming will gain marketing approval for Rhucin late in the second quarter of 2010, at about the same time he expects the company's current cash position to have dried up.
Pharming had a cash position at the end of the first quarter of 16 million euros ($22.4 million). It said in April attracting new financing remains a top priority after previously announcing a restructuring of its convertible bonds and a 20 million euros stand-by equity line with Yorkville Advisors.
But Hilhorst said Pharming should also increase its focus on making product deals. Continued...
