Ksino schreef op 25 februari 2014 13:37:
Super nieuws, vandaar de opleving, nu zeker niet meer wegdoen :
roth2.bluematrix.com/sellside/EmailDo...Healthcare: Biotechnology For full report in pdf, please click here
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Pharming Group NV (OTC: PHGUF) | PHARM.AS - €0.60 - AEX | Buy
PHARM: PDUFA Extension a Non-Event; Reiterate Buy
The PDUFA date for Ruconest has been extended three months to July 16, 2014 based on file submissions to the FDA representing a "major amendment" to the BLA. This triggered the automatic 3-month extension. We believe the extension is a non-event and expect full approval of Ruconest based on the positive Phase III program, under SPA. Reiterate Buy and $3 target.
Event
Pharming and Salix (SLXP-Buy) announced that the FDA has extended the PDUFA date for Ruconest from April 16 to July 16, 2014. We discussed the extension with management. As part of the "back and forth" between the companies and the FDA, responses were provided on February 13th which was considered a "good size package" and therefore considered a major amendment to the BLA filing. Therefore, this triggered the 3-month standard extension.
Impact
We believe the PDUFA extension is a non-event and believe that Ruconest will receive full FDA approval for the treatment of acute HAE. Recall that the BLA was filed off of a positive Phase III program, under SPA. Overall we believe two major factors (of several) will help propel Pharming forward this year; 1) Shire acquisition of ViroPharma for $4.2 billion (Ruconest represents a pure and safer threat to Cinryze) and 2) Salix' acquisition of Santarus (Pharming's U.S. partner). Ruconest is approved ex-U.S. for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. PHARM has also partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a division of Sinopharm, for commercialization of Ruconest in China. We believe that the drug is poised to take over a significant share of the HAE market, given its low COGS allowing for competitive pricing, safety, convenience, and strong efficacy. Ruconest benefits from a benign safety profile, with no thromboembolic events seen to date, compared to plasma derived Cinryze and Berinert with an incidence of ~3.4% rate of thrombosis events. This may be attributable to the plasma derived Cinryze and Berinert with ~20-25% impurities in their formulations.
Action
We reiterate our Buy rating and $3 price target. The company's strategy to expand geographies through collaborations and to develop therapies for rare diseases will bear fruit over the long term, in our opinion. Given the pricing power of orphan drugs and the expanding markets in these indications due to better diagnoses, we believe that Pharming is well-positioned for commercial success.