MI, I just came back from Canacord and Pascoe says the avg. royalty is $2.20, go figure, here's some more take aways from the conf, that Barb is very nice to talk to as well,
1. Vitaros sales are improving in all areas, the new approval areas are for cold temp Vitaros as well, Recordati excited about launching more cold temp product
2. The original launches(UK, Gremany) targeted the most difficult ED patients, better sales are now happening by targeting all ED patients in all areas, (ie: France, Spain)
3. Vitraos USA, is now with Allergan, a brand name operation after the mergers and acquisitions, a good thing, US talks on going with Allergan and FDA
4. Mylan in Canada, all generic compnay, a mess with acquisitions, forget about it for a while, sad no legal recourse due to wording of contract, thanks Damaj, huge mistake Damaj, basic business
5. Rich says the average royalty per unit dose is $2.20, go figure, I'll take his word for it
6. Vitaros does show greater benefit over time, requires instruction, is working consistently with trial results, the more difficult the condition the harder to treat of course.
7. The HAS reimbursement doesn't matter at this point, it's only 15% for certain cases, Marjorelle has their target audience, all ED patients
8. The EU regulators saw Vitaros as a first line for all ED patients due to the safety, suggesting it be tried first, not a niche product, the FDA suggested just PDE failures but she is telling them no.
9. Funding will come form borrowing against Vitaros royalties, some delas , and dilution, and Vitaros income, no surprise
10. They seem very confident about Rayva, the PH2 B will be about 6 months of the home testing, very safe product Barbara said
11. No new NexAct products will happen by the patent expiration in 2019/20
12. Fis. has advantages over Androxal with better trial design and better cooperation with FDA and better added benefits/indications for LUTS, inflammatory prostatitis, sex improvement with ED/libido, as well as T level. Barbara said Repros should have stayed away from the indications the FDA does not like, for example fertility and weight loss, Repros may have a hard time with the endpoints which were not suggested by FDA
13. Femprox is still way back burner, the only near term hope would be , Flib. gets approved, a big pharma picks it up, then the same big pharma co. says hey, let's partner Femprox as well and enter the space with 2 products and 2 indications, but Femporx would need trials first, it may never happen, or may be years away, or not, kind of like Vitaros in Canada
that's it for the moment, may think of other things later, APRI originally was a drug delivery technology company and that changed when Damaj left, they have 3 good drugs and the plan is to develop them. |