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Vertex Pharmaceuticals Incorporated Message Board

  • qdelfan qdelfan Feb 28, 2012 8:29 PM Flag

    Today's Citi investor presentation

    Ian Smith did a fairly good job answering the analysts questions. Of particular note:

    1. Improving New RX numbers over the past few weeks, stablizing at over 1000 new scripts per week, and likely to slowly grow further this year, with the company 'comfortable' with Incivek sales forcasts for the US this year of 1.5 to 1.7 billion. (Fifty thousand patients would likely yield well over two billion, an easy estimate to beat IMO.)

    2. VX 809 and 770 combo data to be released in the second quarter this year to addreess the treatment of the majority of patients with CF, and establish the Phase 3 protocol for VX 809 if the data is positive (which would be safety and a statistically significant drop in sweat chloride, and not necessarily dependent on a specific minimum improvement in FEV-1 after just four weeks of comibination therapy.)

    3. European approval for 770 monotherapy in the third quarter, with the hope that it will include 10% of the CF population (not just the 4% with the 551 mutation) further enhancing potential revenue from VX 770 this year and next, as the broader label for monotherapy is eventually adopted in the US).

    4. The significance of future viral kinetic and safety data from the current Phase 1 trials using the Allios nucs. If that data,to be released in the second quarter is positive, it will be used to develop oral combinations of the Allios nucs, Incivek, and VX 222 with or without ribavirin. Of note was the absence of any even moderately severe rash using Incivek in the just released all oral Incivek, 222, ribavirin study, suggesting an improved safety profile, and potential shortening of duration of treatment in various hep C sub-populations. Vertex will be planning these all oral trials in part in reaction to other company's clinical data to be reported over the coming weeks and months, and intends to remain competitive with its portfolio of DAA drugs to treat hep C.

    Anyone else hear anything of interest from today's presentation?

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    • Good post. I just found yours. CFO also talked about abandoning the response-guided therapy in favor of possible inclusion of arms with the treatment duration of 16 wks and 24 wks. The Ph IIb trial design will depend on the discussion with the FDA.

    • Thanks for the update. To expand on what you said re the CF drugs, fwiw:

      1. The substance re CF starts about 19:30.

      2. I thought the 10% market for 770 was not for Europe but total future CF market for 770 (solo) based on what Vertex expects after further studies of other mutations.

      3. After this and the last conference, I am more and more optimistic that 809/770 will go to Phase 3: After listening to the conference I said to dh with happy tears, this is going to Phase 3. The tone was very different and Vertex stressed that the issue is safety and sc and not FEV1--which they think might take as long as a year to show improvement. Re SC, Vertex noted that in Phase 2a, several participants had substantial reduction in SC and Vertex hopes that with higher dosing and longer time more participants will show higher reductions. And if safe, they will move to Phase 3, whether a reduction in FEV1 or not--a reduction would be great, but not expecting one b/c it might take up to a year to see such an improvement. This conference was the first such affirmative comment re moving to Phase 3. Vertex also noted that it would be in discussion with the FDA concerning what is needed to show clinical improvement and the inference was that Vertex thinks SC should be enough because they are altering the modulation and that is what SC measures. (As an aside, interestingly, at least to me, Vertex noted that it knew the approval of 770 was coming early.) Vertex also noted that it expects Phase 3 to be a year-long study. The presenter pushed Vertex on FEV saying the FDA might require a reduction in FEV for approval and if so, what reduction would be needed for approval. Vertex noted that in the last year Europe approved a drug with less than a 5% reduction.

    • Thanks very much for your excellent summary, very kind that you share it.

      Did they mention or discuss in the Q&A anything regarding the efforts in influenza and the JAK3 inhibitor?

      Did they mention if they will change plans to drop some of the various trials ongoing in HepC that include combos with Interferon given the new focus on all oral therapy?

      Thanks again.

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