* Rhucin marketing application lodged with EMEA
* Pharming says clinical database supports Rhucin safety
* Will seek pre-application meeting in U.S. by end of year
* Shares up 4.1 pct
(Adds analyst comments, details on procedure, shares)
By Aaron Gray-Block
AMSTERDAM, Sept 3 (Reuters) - Dutch biotech firm Pharming (PHAR.AS) said on Thursday it had lodged its highly-anticipated application for marketing approval for its lead product Rhucin with the European Medicines Agency (EMEA), boosting its shares.
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.
But Pharming said it has followed up on and addressed concerns raised by the EMEA during the former evaluation procedure in 2007, adding that the size of the clinical database has been significantly expanded.
Shares in Pharming rose in early trade and at 0755 GMT were up 4.1 percent to 0.58 euros, compared with a 1.4 percent rise in the Amsterdam smallcap index .ASCX
“Although we believe this news is positive, we are still concerned by the financial position of Pharming,” SNS Securities analyst Ilja Zaanen said in a note, adding the filing came “somewhat earlier than we expected”.
“It is our expectation that Rhucin will have an 80 percent chance of approval by the EMEA.”
The company had previously indicated it expected to lodge its filing with the EMEA in September.
Pharming’s equity was 8 million euros on June 30, down from 12.5 million at Dec. 31, 2008 and the company said in July its focus in the near future would be to improve its financial position.
“We are convinced that our current clinical database adequately supports the efficacy and safety of Rhucin,” Chief Operations Officer Bruno Giannetti said in a statement.
Pharming said its next target would be the admission of a Biologic License Application (BLA) for Rhucin in the United States and that it would request a pre-BLA meeting by the end of 2009.
The EMEA’s Committee for Medicinal Products for Human Use has 210 days to approve any given medicine, but by day 120 the committee can send additional questions to the company, at which point the counting of days stops for the ‘clock stop’ period.
Pharming said the questions must be answered within 3 months by the company.
A spokesperson for the EMEA said recently the authority could not indicate the exact timeframe of the entire procedure, but added that based on the 2008 average it takes almost a year for the committee to give an opinion on a medicine.
Pharming, which produces therapeutic proteins in the milk of genetically modified animals, has benefited from government funding and capital from investment funds. (Reporting by Aaron Gray-Block; editing by Elaine Hardcastle and Jon Loades-Carter)