In advance of the annual ARA meeting next month, abstracts of clinical trials being presented are likely to be published next week in the October issue of Arthritis and Rheumatism, the ARA's research journal. I expect the VX 509 data in RA in combination with MTX will be positive, and hopefully so will the study looking at MRI of joints in RA patients treated with VX 509 as well. Perhaps we'll get an announcement on the licensing/co-development deal that Vertex execs have been seeking to expedite the development of VX 509 in multiple autoimmune diseases.
Assuming Phase 3 clinical trials continue to show comparable efficacy compared to the competitors in this market, the preference to use this drug will be based on it's safety profile compared to the competition, and the formulary preference of group purchasers (often price driven all other things being equal), and the effectiveness of marketing by the pharmaceutical company to prescribers, health plan insurance purchasers and individual patients alike through company drug reps and the lay media respectively. One last thing that makes drugs like VX 509 likely to be successful commercially (once approved) is the fact that the diseases it is used to treat are chronic ones that have a high incidence of falling to respond to older treatments over time, creating the need to try newer treatments to replace older ones that are no longer working. This insures a steady and growing population of patients who benefit from the use of these newer agents over time. Dr Leiden knows this potential very well, having been the executive who brought Abbott the rights to develop injectable Humira to treat these diseases when he worked there as head of it's pharmaceutical division. Now he has the opportunity to develop a similarly effective drug at Vertex, (with the help of a larger partnering pharmaceutical company) and market it as an effective choice with perhaps a better safety profile, and of course the ease of once a day oral dosing as rojospan points out, Humira is one of Abbott's biggest commercial successes, and VX 509 could be a similar world wide commercial success for Vertex (even when shared with another pharmaceutical partner) in this evolving therapeutic market
I doubt any positive VX 509 news can stimulate VRTX price trend. Market cap of 17-18 B for VX 809 is fat enough. VRTX will need X ray studies for over 12 months to document reduction in bone destruction i.e reduced osteoclastic activity ( objective test and a key study) before VX 509 can be consider approvable for RA. ACR 20 was 66 in phase 2 A but is subjective test and variable. MRI of the joint and biopsy can be supportive but not the test FDA will buy, plus it will be very expansive to run MRI joints in phase III studies which probably need recruitment of at least 5000 patient data pool for 12-24 months, just for efficacy and at least 1000 patients for long term safety for 3-5 years.
My biggest fear is what if VRTX decides to drop development of VX 135 based upon liver enzyme risks. If 3 patients can have elevations out of 10 patient, it ain't good, no matter what the dose was.
Last investor conference call has stated that a new molecule will be coming to pipeline next month and at the beginning of next year. Any clues?
Hold on to your shares because I think shares will be stressed as usual in Oct and Nov when ever hepatitis news comes. I bought lots of preparation H.
With all due respect, how many times has a post with this basic message been posted here? An investor conference or earnings announcement is due and up pop the usual posts of impending VX-509 and VX-787 data and/or partnership announcements. Like waiting for Godot and the joke is on the investors. I hope you're right but history says this management team just can't deliver in a timely manner.