It allows Leiden to PRETEND he is working hard to boost pps. So far his actions at the helm have not had very good results for pps because investors for the most part consider VRTX as a one drug pony with several competing drugs in the works.
In my opinion the BOD should fire Leiden and find someone who is capable of beefing the pipeline.
VRTX has a bloated number of employees which must include many scientists. My question is what are all of these scientists doing? How about having some of these scientists work on other possible drugs and if they pass phase I then find big pharma to partner with VRTX whereby they can underwrite the cost of phase 2 and 3 and if successful VRTX could get royalties on the sales. I think I have the answer to that as to why it will not happen. It is because VRTX leadership has BIG egos and consider turning their inventions to others for development beneath them!
why is VRTX participating in such conferences when they have nothing to talk about, but potential drop-out rates for orcambi? Such discussions will not enhance investors trust in the company.
As has been mentioned before, in addition to Leiden getting all of those free shares, and other companies developing Cf drugs to compete with VRTX and the lack of other products being pushed through the pipeline, the other factor that is affecting pps is the Hillary factor. Threats of drug pricing, even though I doubt it it will happen with the republicans in control of both houses, nevertheless, has spooked investors.
Here is the statistics about biotechs for the past 6 months:
VRTX down 38%
NBI down 28%
BTK down 28%
IBB down 28%
I believe VRTX has gotten hit harder because of the above mentioned reasons unique to it.
I agree that a take-over is highly unlikely. Guess, all of us don't understand why VRTX has lost one-third of its value in the last few months. There have been no negative setbacks that might explain the drastic loss in value.
100% with you. With the CEO gets so much total compensation from his job and the high price of the company, I do not see VRTX is a takeover target although on the spot for a decade...
I hope I am wrong about this but I just do not believe VRTX is a good takeover candidate. Its present market cap is $20+B. A 1/3 premium makes a buyout cost around $27B which makes it somewhat a large investment for even some of the pharma biggies. Add to that Leiden's concentration on CF at the expense of slowing other products through research as well as competition from other drug companies with their CF drugs nipping at VRTX's heels-- I simply am not very optimistic about a buyout. My hope is that VRTX's additional CF drugs will cover more patients and revenue would increase soon.
As I said I hope I am wrong because unfortunately a good portion of my investment is tied in this stock.
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Sanofi is open to acquisitions in the market for rare disease treatments in a sign of confidence that the high prices commanded by so-called orphan drugs are sustainable.
David Meeker, head of Sanofi’s Genzyme specialty care business, said rare disease assets were among the French group’s potential targets as it hunted growth. Acquisitions were possible “up to the size of Genzyme”, which Sanofi bought for $20bn in 2011, he added.
Mr Meeker would not be drawn on the identity of potential targets. There are numerous small and midsized drug developers focused on rare diseases, mostly in the US, and their valuations have fallen since a bull run in the sector ended last summer.
This has fuelled expectations that big pharmaceuticals groups could go bargain-hunting, but Mr Meeker insisted Sanofi would remain disciplined. “Valuations have come down but from high levels,” he said. “There is a certain resetting of valuations. .......... From Financial Times
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An absolute change of FEV1 at an increase of 8-9%? That is very optimistic. Ivacaftor and VX-809 only have ~3% absolute FEV1 increase for #$%$ 508del in Phase 3, as I recall. But I do hope your prediction is true...
Estimated Primary Completion Date: February 2016 (Final data collection date for FEV1)
[Official Title:] A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
[Official Title:] A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
The second study above is a 300 participant trial for VX-661 + Kalydeco to treat people with residual function mutation in one allele and 508del allele on the other. I am predicting an absolute change of FEV1 at an increase of 8-9 %. I am guessing that the protocol is similar to that of the study for which the FDA sent a CRL.
VRTX has not disclosed what additional data FDA has requested. Given the small patient numbers it will be impossible to conduct meaningful classical phase III studies. So I assume it is something else that is missing, especially since VRTX has stated that FDA is willing to consider approval for sNDA for orcambi without phase III data, unlike European authorities that insist on phase III for orcambi sNDA Less
Verity. Thanks for your thoughtful and insightful reply. I realize how very frustrating delays like this are to you and the CF community affected by these decisions. Obviously, the FDA has to be cautious with young children, but the safety of Ivacaftor in the pediatric population is well established and giving the drug a conditional approval requiring clinical phase 4 data to document efficacy over a longer time period in all 23 residual function mutations would give the proof the FDA is demanding and save lives at the same time. Maybe the White House advisers with an interest in 'personalized medicine' could be asked to have the FDA submit this idea to an FDA advisory committee to allow input from experts and the CF community on the idea of an expedited conditional approval for this sub-population of CF patients likely to benefit?