Another investor conference...... another disappointment. Where do you start with the problems with the call?: Ian Smith is the world's dullest presenter and wasn't helped by the fact that they had nothing new to say. Oh wait, there was news- They continue to be shocked by the rapid decline in Incivek revenues and now realize an all oral regimen is the future of HCV treatment. Influenza data "sometime this year"- in other words delayed. And the most disturbing aspect of the presentation? Absolutely no mention of 2158. Eerily reminiscent of the death of the epilepsy program; no announcement, just silence.
I would agree that the last two investor conference presentations by Ian Smith were not very exciting, but the Alios 2158 study was mentioned in the Q&A of the MS conference and the timing of the release was confirmed to be in September, so we can anticipate some news next week on this front. The way the stock has been behaving, I am hopeful for another postive result. This will be taken as another confirmnation for the future participation of Vertex in the develpment of all-oral GT 1 hep C treatment regimens. I noted that the timing of the release of the VX 787 influenza data was mentioned in last week's UBS presentation as later this year, but that does not imply any delays or setbacks in the development of this drug. The epilepsy durg gets no mention but is still in devleopment and the clincialtrial.gov website still lists the VX 765 seizure disorder trial as continuning to recruit patients at mutiple study centers acrss the country.
As Vertiy mentioned in her post, the North American CF meetings in Florida starting October 11 will likely be a time for further announcement from Vertex about the progress it's making in the ongoning clinical studies in expanding the use of Kalydeco monotherapy to as many as 20% of the Cf population, It may also give updates on the progress of clinical trials treating CF patiients who are homozygous for delta 508 mutation with combination therapy with VX 809 or VX 661 and Kalydeco. Patience with this stock is paying off (even with the drop in Incivek sales, there is a steady cash flow from both Incivek and Kalydeco which continues to fund the company's R&D pipeline), and the stock is acting fairly strong (just 10% off it's 52 week high) going into the final week of this quarter. Good luck to all.
GSK is combining their NS4A drug with Incivek in a phase II trial for their cocktail. Roche is combining R7128 ( NS5B polymerase inhibitor developed by VRUS) with Incivek in phase II trial. JNJ is testing one of the TMC compond with Incivek, BMY is using Incivek with Interferon Lamba in their phase III study. Also worth to mention Incivek 12 week therapy for IL28 CC polymorphism results due 12/12, on going trials in HIV and Hep C and also in liver transplant. Last but not least VX 222 12-16 week all oral therapy phase II now fully entrolled, results due around 1/2013. I see more and more studies of quad therapy model.I see roburst growth of Incivek sales in future and hopefully the new commerical cheif with do a better job.
GS7977 may be a good drug for Hep C G2 & G3 but I don't see a real threat from this drug in G1 a. Infact their trial for G1 also include G4,G6 and to me it seems odd. I have not seen any safety data of combining GS 5885 and GS 7977 so far. Do you think FDA will let GILD run a phase III trial of this single magic pill without a phase II safety data with recent incidence of INHX 189 causing heart failure?
I've never listened to an investor conference by anyone but Vertex so I have no way to compare the style or content. And I wasn't able to listen to Q&A for the last one b/c they changed rooms and it wasn't recorded. BUT, from the questions from the previous week's one, the investors there aren't on their game either. No one asked at the prior conference re the Arm 3 new dosing of the combo 2x and 3x a day. And I wonder if anyone asked at this conference about the new Phase 2 for Kalydeco which if you look at the inclusion criteria seems broad enough to include nearly anyone who has any channels at the cell surface and that this could get almost 20% of the CF population included in the label. More information will be hitting the public in the next month with the CF conference so I expect a higher uptick coming again soon.