Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

quote:

sniper22 schreef op 12 januari 2011 21:41:

Positive view from Edison analysts

Commenting on the deal with Santarus, analysts at Edison Equity Research said it is excellent news for shareholders. It provides 11.8 million euros ($15 million) cash upfront with milestones (including $5 million due on BLA filing) and a product purchase and royalty agreement. Santarus will co-fund the clinical trial of the important kidney indications of antibody-mediated rejection (AMR) and delayed graft function (DGF). The FDA will review the HAE BLA, due to be filed fourth-quarter/early 2011, so US sales are possible from second-half 2012 to first half 2013, the analysts noted.

Unlike the European Union approval submission, which is limited currently to HAE, the US BLA covers both HAE, an orphan market with three competitors, and the open potential indications of AMR and DGF. US pricing on acute HAE therapies set by Dyax’ Kalbitor (ecallantide) is around $8,000 per dose. Pharming is now on a solid basis with an imminently approved orphan EU product, a route to FDA approval of Rhucin, EU and US partners and new indications about to enter trials.

The Edison team has previously opined that use of Rhucin in rejection is speculative. However, use of C1-INH to prevent cardiac reperfusion damage has clinical support and could be a $2.6 billion blockbuster (TPL May 18

www.thepharmaletter.com/file/98324/ph...

toch belangrijk om te weten dat de indiening van de BLA mbt rhucin in de US niet alleen HAE betreft maar ook AMR en DFG waar nu onderzoek naar gedaan wordt.

quote:

Declan schreef op 12 januari 2011 22:27:

[...]

Waarschijnlijk dat de lange gesprekken tussen FDA Pharming hun vruchten zullen afwerpen.
En natuurlijk zijn de door dezelfde FDA gesponsorde onderzoeken ook een teken aan de wand.
Laten we die laatste dagen rustig afwachten het komt goed.

Socius zal ook de belangen van andere (geldschieters) dienen te behartigen en geld is geld.
Of die aandelen nu bij A of bij B liggen.
Snap de sores die dat opwerpt wel maar het gaat nergens over.
Sniper prima ondersteunende materie AB

Ruud..

quote:

Poemel85 schreef op 12 januari 2011 22:54:

Afhankelijk welke afspraken er gemaakt zijn!