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Vertex Pharmaceuticals Incorporated Message Board

qdelfan 35 posts  |  Last Activity: Apr 22, 2014 9:17 AM Member since: Sep 30, 2007
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  • No surprise that in an election year pricing of new breakthrough drugs will draw populist rhetoric from politicians. It is ironic that he very same Congressmen often hold hearings on the need for the pharmaceutical industry to develop these types of drug to help their constituents when advocacy groups for these patients dying from diseases that desperately need treatment get the attention of lawmakers. Henry Waxman's letter is not motivated by re-election aspirations since he is retiring at the end of this year. It is a reality that the high cost of drug development and the pressure to control the rate of inflation in medical costs are a serious threat to advancing medical research to help patients suffering from serious life threatening disease. Congressmen have to acknowledge the current high costs of treatment of these diseases with less effective and less tolerable treatments before weighing in on what a breakthrough drug is worth. Biotech executives and their lobbyists have clearly need to educate lawmakers and the public on the relative value of these meds compared to the cost of current and less effective treatments

  • Reply to

    VX 765 and AIDS. Huge upside

    by rojospan Dec 19, 2013 8:52 PM
    qdelfan qdelfan Mar 15, 2014 5:56 PM Flag

    New meds to treat chronic MS involving remyelination, if safe and effective, will be another transformative treatment. It will surely get investors attention given the current revenues generated to treat MS. If VX 765 works as hoped in the Phase 2a trial being planned in the treatment of HIV, Vertex will have some major catalysts to allow it's continued growth following it's approval of the CF drugs!

  • Reply to

    VX 765 and AIDS. Huge upside

    by rojospan Dec 19, 2013 8:52 PM
    qdelfan qdelfan Mar 14, 2014 9:35 PM Flag

    Rojospan, I thought you might enjoy this news release from Gladstone Institute from last December. Today I called the spokesperson from Gladstone, responsible for this press release, and she confirmed that Vertex and Gladstone will be undertaking a Phase 2A clinical trial,after receiving FDA regulatory approval, to test the efficacy of VX 765 in the treatment of HIV infected patients. VX 765 could become a transformative treatment that revolutionizes HIV treatment in 34 million patients.

    SAN FRANCISCO, CA—December 19, 2013—Research led by scientists at the Gladstone Institutes has identified the precise chain of molecular events in the human body that drives the death of most of the immune system’s CD4 T cells as an HIV infection leads to AIDS. Further, they have identified an existing anti-inflammatory drug that in laboratory tests blocks the death of these cells—and now are planning a Phase 2 clinical trial to determine if this drug or a similar drug can prevent HIV-infected people from developing AIDS and related conditions.

    The Phase 2 trial—which will test an existing anti-inflammatory’s ability to block inflammation and pyroptosis in HIV-infected people—promises to validate a variety of expected advantages to this therapy. For example, by targeting the human body, or host, instead of the virus, the drug is likely to avoid the rapid emergence of drug resistance that often plagues the use of ARVs. The anti-inflammatory may also provide a bridge therapy for the millions without access to ARVs, while also reducing persistent inflammation in HIV-infected people already on ARVs. Many suspect this inflammation drives the early onset of aging-related conditions such as dementia and cardiovascular disease. By reducing inflammation, the drug might also prevent expansion of a reservoir of latent virus that hides in the body where it thwarts a cure for HIV/AIDS

  • Reply to

    Losing -2.28 this year

    by pvnguyen1 Mar 14, 2014 2:38 AM
    qdelfan qdelfan Mar 14, 2014 1:49 PM Flag

    Actually, shorting VRTX is very high risk.

  • Reply to

    PPS if Vx 809 is a success

    by drsganesh Mar 10, 2014 5:50 PM
    qdelfan qdelfan Mar 11, 2014 2:19 AM Flag

    This might encourage your sense of the potential value of VX 809 in combination with Kalydeco (excerpted from a blog written in October of last year by a pediatric cf patient's parent:

    "From the Trenches

    What follows is a first hand account of someone who is enrolled in the phase 3 vx-809 trials. He’s ddf508. I suspect this blog will get taken down at some point so I thought I’d copy and paste it here just in case. I don’t know this guy, can’t vouch for the accuracy of any of it. But it makes me hope…

    “Quick disclaimer, this is just a personal journal of what I have been experancing on the 24 week VX 809/ VX770 study for CFers that have the double delta F 508 gene type. Please just remember that we all respond differently to treatments……

    My lungs haven’t felt this good in 10 years. I’ve now been in the vertex drug trial for 3 weeks. My PFT’s have gone from 53% to 64%. I’m a lucky man to be getting the goods"

    "I have now been on the drugs for the past 3 weeks. Things have settled down, I feel like I’m at my new normal. PFT’s feel like they are in the low to mid 60′s, I feel like I’m moving a lot more air in and out of my lungs, my mucus is still greenish but down in the amount I’m brining up, I’m guessing 1/3 of what it was. I feel very lucky and a little guilty for getting these drugs. It’s just kind of weird. It seems to be the closest thing to a “cure” I have ever heard about."

  • Reply to

    Outlook: Vertex vs. Alexion

    by thirdmeinvestor Dec 8, 2013 2:11 PM
    qdelfan qdelfan Mar 2, 2014 2:54 PM Flag

    Thank you Third, once again for your analysis. Looking forward to good results for VX 809 in the next few months!

  • Quidel's CEO will be speaking tomorrow at the Cowen Healthcare investor conference in Boston. The debut of the new Quidel website/homepage this week exemplifies the focus the company has on transforming it's product line to the future growth expected from it's new molecular diagnostic tests as well as Sofia, it's new immunoassay testing platform. Sofia is already adding market share to it's established and successful Quickvue lateral flow immunoassay diagnostic product line. The CEO's presentation tomorrow will be a good indication of the intermediate and long term vision of this company's potential growth from it's pipeline of new molecular and immunoassay diagnostic tests.

  • Reply to

    Outlook: Vertex vs. Alexion

    by thirdmeinvestor Dec 8, 2013 2:11 PM
    qdelfan qdelfan Mar 2, 2014 10:34 AM Flag

    Third, Cohort 2 and 3 of the Phase 2 809/770 clinical trial data showed better results in both Absolute and Relative FEV-1 improvements after just four weeks of combination therapy than you are predicting for TRAFFIC and TRANSPORT. In anticipation of possible further improvement after 6 months of treatment, would you not expect at least the same improvements in FEV-1 reported in Cohorts 2 and 3 to be reported as 4 week improvement results in the Phase 3 clinical trials, with the possibility of even greater improvement in FEV-1 at the end of the 24 week trial period?

  • qdelfan qdelfan Feb 20, 2014 8:40 PM Flag

    Tomorrow will be painful for shorts. Listen to conference call.... Growth story continues.

  • qdelfan qdelfan Feb 15, 2014 6:52 PM Flag

    The above information from the Vertex 2014 annual report to shareholders implies expectations of rapid regulatory approval of Ivacaftor/Lumacaftor treatment for CF homozygous for 508d mutation and commercial launch in mid-2014. Management would not invest in this type of infrastructure without a high degree of confidence that the combination drug will be approved for commercial sale this year. Investors will likely drive the stock price steadily higher in anticipation of commercial launch, as Phase 3 trials approach completion in the next two months..

  • Manufacture of Co-formulated Ivacaftor/Lumacaftor

    We are planning to use a continuous manufacturing process in order to manufacture co-formulated lumacaftor and ivacaftor tablets. We have established continuous manufacturing capabilities at our third-party manufacturer in the United Kingdom, which was used to produce a portion of the clinical trial supplies for our Phase 3 clinical trials of lumacaftor in combination with ivacaftor, and are in the process of establishing continuous manufacturing capabilities and seeking validation for these capabilities at our new facility located in Boston, Massachusetts. We are upgrading the continuous manufacturing process at our third-party manufacturer and are scheduled to begin producing co-formulated lumacaftor and ivacaftor intended for commercial use in mid-2014. Continuous process manufacturing connects the processes used in traditional batch manufacturing and uses on-line monitoring in order to increase control of the manufacturing process. The goal of continuous process manufacturing is to reduce material waste and cycle times and improve yield, which may result in reduced cost, reduced development and production timelines, lower inventories and increased market response flexibility. While continuous process manufacturing has been used in many industries, we believe that we would be the first company to seek approval for an NDA using a continuous manufacturing process. As a result, we also have designed and tested a non-continuous process for manufacturing co-formulated lumacaftor and ivacaftor tablets that we would seek to utilize if we experience delays associated with the continuous manufacturing process.

  • qdelfan qdelfan Jan 30, 2014 10:48 AM Flag

    Given the variability of severity of CF end organ pathology, even among CF patients with the same mutations, it is not surprising to see variability in clinical measurements of sweat chloride in response to treatment with a combination of CFTR corrector and potentiator. Decreases in Sweat chloride is not as strong a predictor of clinical benefit of these drugs as was once thought. This was demonstrated last year in the VX 661/770 phase 2 clinical trial. Why the sweat chloride does not drop as much as FEV-1 and BMI improves could relate to other factors such as how much drug penetrates the cells of sweat glands in the skin, as well as differences in CFTR expression in the skin versus the lungs and pancreas. Your theory of alternative mechanisms of action of these drugs benefiting CF patients in terms of bicarbonate transport is interesting, and may be another factor. It is interesting to note that TRAFFIC and TRANSPORT do not even list sweatchloride as a primary or secondary endpoint. More important is FEV-1, BMI, frequency of pulmonary exacerbatrions/hospitalizations, and quality of life questionnaire answers. Hopefully these Phase 3 trials will prove meaningful improvement for the homozygous 508d patients, with the heterozygotes next to get the opportunity for clinical trials in triple drug combination treatment.

  • Reply to

    4th quarter conference call this Wednesday

    by qdelfan Jan 26, 2014 4:03 PM
    qdelfan qdelfan Jan 30, 2014 12:41 AM Flag

    A frank and informative Q&A. Of course, the main focus was getting VX 809 and 661 approval for CF and expanding the mono-therapy label for Kalydeco, to finally get the company on a path of sustained revenue growth and profitability. The fact Ian Smith mentioned that significant dollars were expensed in the budget this year for production of lumcaftor (VX 809) suggests optimism (IMO) about the likely success of Phase 3 VX 809/770 clinical trial results due out midyear. Mention was also made about talks that continue regarding partnering/licensing VX 509 and 787...... hopefully with some meaningful revenues that will be possible from milestone and royalty payments if the drugs get regulatory approval, With today's announcement of positive clinical trial data after 24 weeks of treatment of RA in combo with MTX, maybe a lucrative deal with milestone and royalty payments can finally be negotiated with a larger pharma who can bear the clinical trial costs for phase 3 studies for RA and phase 2 trials testing VX 509 in other autoimmune diseases. I got the feeling Vertex is likely to sell or license its interest in VX 135 to BMS or any other interested party ready risk investing in costly studies necessary to try to enter, in the next two years, the competitive and crowded field of hep C all-oral treatments. No mention yet of discussions reportedly being held with Blackstone Institute researcher, Warner Greene and Vertex execs to develop VX 765 to treat HIV infection, (following the Nature article published this month by Warner Greene, showing the potential for this drug to actually clear the HIV virus in vitro.) Lastly, we got a mention of a novel and potentially transformative approach to treating MS with a remyelination drug, to correct the underlying pathology of MS. IF safe and effective, it would be a huge breakthrough and a novel treatment for the chronic progressive form of this disease which is often crippling and eventually lethal in its worst form.

  • Reply to

    4th quarter conference call this Wednesday

    by qdelfan Jan 26, 2014 4:03 PM
    qdelfan qdelfan Jan 28, 2014 12:22 AM Flag

    ...and of course let's not forget the questions regarding the status of discussions with BMY to partner VX 135 with BMY's daclatisvir to develop it's potential as another all oral treatment for hep C.

  • Anyone expect anything new to be reported around the conference call this week? Q&A during the conference call will likely inquire into the timeline for NDA submissions for VX 809, 661, and expanded label approvals for 770 in the US and EU. However questions about VX 509, VX 787, and perhaps VX 765 being resurrected for clinical trials to treat HIV, as well as pre-clinical pipeline drug candidates (e.g. second generation correctors to treat CF, chronic MS, and oncology) may also be discussed.

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