Member Info for Alquemie

Based on what RP have disclosed, estimated approval timelines are: HK- August 25th interims indicate that submission is �in preparation�. From receipt of a complete submission, review and grant takes five months. However, time to submission will depend on which manufacturing data is submitted. �Historical� 12 or 20 dose CMC, as long as it includes the necessary region specific stability data, would not entail delay, but if they go with the 300l 12 dose data, earliest submission would be Q1/Q2 2018. So, Q1 2018 possible, but could go to Q3-ish. There�s a potential complication in that, with the transfer of the European MA to Recordati, Plethora may no longer be considered as the wholesaler by the HK regulators. China- there is a raft of amendments under discussion which could reduce approval from around the five years it currently takes. Most are intended to speed Chinese access to leading edge products, but there is an amendment relating to drugs with no patent protection in China which, in theory, could allow a Class 3 filing as a generic product. However, I�d still assume 5 years until if and when relevant amendments are incorporated. CFDA considers HK and Macau as not being China for regulatory purposes, there is no �backdoor� into China.No OTC registration without history of ex-China OTC use. US- Interims state that an FDA meeting is scheduled sometime in Q3, and I�m assuming that this is to discuss the crucial PRO issue and fixed-dose combination criteria. The PRO was claimed to have been submitted in March 2016, but with no announcement or study registration, it�s reasonable to assume that the FDA still have issues with it. If the COA does give the thumbs up this year, two part validation and pivotal study with revised endpoints would take a minimum of 18 months, plus a year for submission including pre submission review. So, earliest approval mid 2020.

Prof, apologies if I’ve not followed your question correctly, but if you mean sampling, then yes, it’s a standard element of any promotional campaign. Like all Rx drug promotion, it’s pretty rigorously regulated at national level, with strict limits on the number of samples and the duration of sampling post launch (Spain is probably the least restrictive), with prescribers having to submit a written request for samples. Some hospital systems completely ban sampling. If we take Germany, there are around 6,000 registered urologist and andrologists. Being very generous, Recordati might be able to reach half either directly or indirectly. Even if all of them could be faffed to submit a written request for samples, with a mandatory limit of two samples per prescriber per year, 6,000 canister would saturate the potential prescriber base.

MattD78, the good old Arrhenius equation is pretty reliable when it comes to establishing shelf life and I don’t see a wait for real time data being a cause for delay. However, given that the changes are hugely in favour of the licensee (and simple enough so that a side letter to the original agreement would suffice), I suspect that there is something else in the wind, my guess being cost of goods, something alluded to with regard to the otherwise unnecessary scale up (at 100l scale, or close to 20,000 canisters per run, you could sample every prescribing urologist and andrologist in Germany and Italy).

Pomander, not claiming that my Italian is any better than Google Translate, but I beleive that the €113m refers to the increase in total company sales in H1 2016. Virirec net sales (Spain) ran at around €150,000 per quarter in 2016, might be doing slightly better since expansion into other territories. As an aside, Apricus disposed of the entire ex-US rights to Vitaros/Virirec in March (to Ferring) for a total of $12.7m, including inventory.

Ooooh, Pomander...surely you wouldn't be casting a fly over my nose? While I'm sure that Dr W is simply bouncing with confidence, the write down in value and adjustment in deal terms suggests that Recordati's Fortacin spectacles are now a much paler shade of pink. Not something that will ruffle the true believers, but those of wavering faith might consider the disconnect between RP's crayon 'n' glitter estimates and the licensee's perspective as defined by the revised deal terms and structure.