Shares in Pharming Group have edged up again after the Dutch biotechnology company gave analysts more details about a successful Phase III study of Rhucin, its treatment of acute attacks of hereditary angioedema, and spoke about securing a licensing partner for the treatment in the USA.
In a European Phase III study, 28 patients receiving Rhucin (recombinant human C1 esterase inhibitor) reported first relief at a median time of 60 minutes compared to 8.5 hours for those who received placebo.
In addition, patients on the Pharming drug reported minimal symptoms at a median time of 6.1 hours compared with 20.2 hours for people who received placebo and 100% of patients in the Rhucin group experienced sustained relief without a relapse of their attack symptoms.
After a review by the independent data monitoring committee, randomised treatments in the trial have now been stopped and the study amended so patients may continue to have access to Rhucin. The positive results from the study have been given to the European Medicines Agency which could lead the way to a launch in the first half of 2008. The data has also been passed to the Food and Drug Administration in the USA, where a clinical trial assessing the safety and efficacy of Rhucin, which is a human protein developed through Pharming's proprietary technology in the milk of transgenic rabbits, is expected to be completed in the next few months.
Bruno Giannetti, chief operations officer at Pharming, said the data show that Rhucin “is a very fast acting product that we expect to have great therapeutic benefits” and it has an excellent safety profile “based on the results of various studies in which, in total, well over 100 infusions were given to subjects”.
The strength of the data is such that Pharming is in a good position to negotiate an interesting licensing deal and the firm confirmed that talks with potential partners in the USA are well advanced. If approved, Rhucin sales could be in the region of 600 million euros.