jurpsy @ 13-08-2014 15:24:45 (http://www.ErikErik.com / Pharming)
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Impact –
Docs have major new message for patients
The approval in the U.S. represents a major catalyst for Pharming and
Salix, in our opinion and could represent a sea change in how physicians
can now message about products available to HAE patients. We believe
Ruconest represents a serious threat to Shire's (SGHP-NC) Cinryze and
Firazyr. Previously physicians could only discuss/recommend what is available
to them, namely the plasma derived products such as Cinryze and Berinert,
which are associated with underlying risks (discussed below). Additionally,
Firazyr is associated with ~97% of injection site reactions, and upwards of
30% of breakthrough highlighted by relapse/worsening of symptoms while on
therapy. Therefore, we believe docs will have something new to talk about
in Ruconest, with the added benefit of talking about the favorable safety
profile of the drug, which is based on its recombinant nature. We believe
this differentiation, beyond the underlying efficacy, will allow Ruconest to be
a strong competitive threat to the current therapies. Economics are quite
favorable, in our belief, to Pharming. For the first $100 million in sales,
Pharming is entitled to 30-40% of net sales based on a combination of both
royalties and drug supply to Salix. Salix/Pharming are expected to start a
Phase III study in the prophylaxis setting, which could pose a serious threat
to Cinryze. Additionally, FDA guidance will be sought to discuss potential trial
designs for pancreatitis.
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