Do you know any details of the terms with JNJ. Best I know was 30 million upfront payment. Typically royalties on this kind of phase 1 molecules runs as 10% of total sale i.e 10% of 1 B is 100 million net and no over head. ( Tamiflu deal of GILD with Roche). If VX 509 MRI studies are good, I don't see any reason, why VRTX should not advance this molecule into Phase 3 on their own. Expanse is 200 million, reward is 500 million min x 15 years.
I am sure they will be testing VX 787 in wildtype linfluenza in a phase 2B trial during the coming 2014-15 flu season. If safe and effective, look for Phase 3 trials and a NDA in the 2016-17 flu season.
Two comments: First, excellent execution of mediocre strategy always beats mediocre execution of excellent strategy in business. Leiden's execution is excellent with regard to establishing and protecting the CF Franchise. He is covering all the bases.
Second, I have been around Vertex for more than fifteen years. It has always been a great Science company run by great scientists whose varied interests were continuously funded by vastly dilutive stock sales. With a constant level of holding on my part my proportionate share of the company has fallen by two thirds. I have always loved the science but I am ready for them to fund themselves.
To every thing there is a season (The Byrds). The time for more broad scale efforts is approaching and I hope that M. Leiden makes the turn when that is appropriate (and is thinking about the issue now) but Not Now.
Leiden was asked last year what he brought to Vertex as CEO. His answer was 'focus' on what needed to be prioritized ie instead of developing multiple drugs in multiple diseases all at once, narrow the development in house to drugs most likely to be best return for the investment that Vertex could develop itself and partner and license those drugs with longer term investments required with more resources required by larger partners in drugs with a established competitive markets.... ie partnering 787 with JNJ/Jannsen for influenza, and looking for partners for 509 for RA (if anyone is still interested), and making the CF pipeline the entire focus for now until future cash flow from CF drugs permits advancing the clinical development of the non CF pipeline including MS, Huntington's, oncology etc.
"I am still disappointed that VRTX does not offer information on other programs beside cf."
I think Jeff Leiden is not a multi-task person. I think he is one of those who can concentrate on one thing at a time. I believe the BOD should start asking some serious questions about this issue and if Dr. Leiden can not handle the task properly they should find someone else who can.
which is (clinicaltrials.gov)
Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) [ Time Frame: From Baseline at Week 24 ]
At least the company has not released this to public yet.
As most people know, FEV1 was measured many times during the study, the company could just pick some good visits to make ‘2.6%-4.0%’ – even this is not impressive according to many CF doctors.
yes, the 809/770 combo is a breakthrough. Nevertheless, we are still in a "incivek scenario": better than SOC, but much room for improvement. 3% fev1 needs to and will be improved, 661 may be an important step. I just hope VRTX does not repeat the incivek disaster and will try to acquire better and alternative correctors/potentiators and alternative technologies.
I am still disappointed that VRTX does not offer information on other programs beside cf.
btw, who will replace the CSO Mueller?
The 809/770 is a breakthrough for 508d homozygotes and will be approved in the US and aciheve rapid adoption by cf patients as the first treatment addressing slowing the progression of the underlying cause of their disease. Just the decrease in infections and hos[italizations will save health care expense to offset cost of the drugs. The benefit is sustained and side effects are minimal. This is why the majority of analysts have raised PTs and given VRTX BUY/outperform ratings.
the modest fev1 values will remain VRTX damocles sword. share price will stabilize once pricing and acceptance of the combo by cf patients is known
for the time being, just don't loose your faith
I appreciate the board clean but the post was made looking for a discussion from glad, three, robo and a few other board contributors for serious comment. The CDC has let Ebola spin out of control, this is the time where possible drug candidates need to be explored.
Reliance on a Canadian pump and dump pork funded con job like TKMR is nothing less than a joke.
How does it feel to be looking up from the bottom of the bell curve Jack? This data is now beyond phase III and soon to be post-market (phase IV) and you are still dwelling on a phase II press release? Stay stationary and keep dwelling...the rest of us won't look back.
The company, Wall Street, and some people here (knowing something I guess) want to make a story using exacerbations, but exacerbation is only one of 20+ secondary outcomes as published in clinitrials.gov. So exacerbation can’t help very much for approval.
The key thing is:
Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) [Time Frame: From Baseline at Week 24 ]
Which has not been shown to public yet! Smelled something? I bet!
Who is Michael Bayle, MD? If it was Michael Konstan, MD it would be more credible, but I bet Dr. Konstan had refused to do this presentation (my opinion). Just do a google search you will know what I am talking about!
Mr/Mrs Smith: I dug into their Phase 2 study in clinitrials.gov and found it was only a 4 week study! They found some marginal FEV-1 improvement over 4 weeks. Do you think this 4 week marginal improvement can be easily carried to week 24 and 48? Use your common sense Mr/Mrs!