Biotech Values

[DewDiligence]

Pharming, the Dutch company that once seemed like a bright
star in transgenics, is attempting to get the EMEA to approve
Rhucin as a treatment for acute HAE—for the third time!
Still no firm guidance as to when Pharming will submit a Rhucin
BLA to the FDA; all Pharming is promising is a pre-BLA meeting
with the FDA by the end of 2009.

http://www.reuters.com/article/marketsNews/idCNLO8493320090924

›Pharming's Rhucin Evaluation to Start

Thu Sep 24, 2009 4:06am EDT

AMSTERDAM, Sept 24 (Reuters) - Dutch biotech firm Pharming (PHAR.AS) said late on Wednesday that the European Medicines Agency (EMEA) has begun the scientific evaluation of its lead product Rhucin in its third attempt to win marketing approval.

The regulator 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 the company has 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.

Pharming said the EMEA informed it on Wednesday it had completed the validation of its application dossier, allowing the start of the scientific evaluation.

"The start of the procedure is positive news for Pharming. If there are no unforeseen circumstances, a decision on the approval of Rhucin can be expected before year end 2010," SNS Securities analyst Ilja Zaanen said in a note.

Pharming shares were up 9.2 percent at 0.48 euros by 0749 GMT and were the biggest winner on the Amsterdam stock exchange.

The next step in the process is the drafting of a list of questions by the agency's Committee for Medicinal Products for Human Use which could take 120 days, Pharming said.

It added that it may expect the adoption of the final opinion from the committee within a total of 210 days of review, excluding any clock-stops triggered by questions the company has to answer.

Pharming, which produces therapeutic proteins in milk of genetically modified animals, had lodged its request for marketing approval of Rhucin with the EMEA at the start of September.

The company had previously said that its next focus 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.‹