We have had a number of big named Enhanze partners over the past 5 years but other than the initial up-fronts we have earned nothing from them. We have no new Enhanze drugs anywhere near approval and indeed had 3 Enhanze drugs dropped in 2016. The still much touted story of 150 potential drugs that could benefit from Enhanze is looking increasingly unlikely. And to rub salt in the wound Shire doesn't seem to be putting any serious marketing effort into HyQ where sales still seem to be minimal. I am also concerned about the US doctor and hospital reaction to SQ Mabthera and hopefully SQ Herceptin. Remember when SQ Herceptin was first discussed with doctors and hospitals in the US 5 years ago there was an outcry about lost revenues and profits from the switch from IV to SQ and threats to switch away from Roche products if it was introduced. Hardly a word about patients benefits! I'm sure this reaction has been the main reason for the delays in obtaining FDA approvals rather than the usual one about expiring patents, which always struck me as complete nonsense.
No word from the sages on this Board about the submission of the Phase 2 PEG data to the FDA and what the next move on that is likely to be. Presumably some discussions must be taking place on the likelihood of accelerated approval based on the Phase 2 data especially with the possibility of using an initial early analysis from the Phase 3 trial as further confirmation of the Phase 2 data prior to any approval being granted.
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