No, but I think the market correctly believes you need at least 6% with dd508f for it to get 3% for ddf508. But I think the market will wrongly think that it is bad if the improvement isn't enough to get to heteros now. It would be amazing if they couldn', but still good to have 661 fast tracked.
For 661 phase 2, did VRTX indicate what % FEV improvement it would consider a success? Did the study have an end point guideline? Did they mention the 6% as an expectation?
In my opinion (for what that is worth) I think if the results are somewhere around 4% or above the reaction should be ok.
I think but would have to check that this time it was dosed fully throughout the study and didn't start with mono dosing and that could definitely improve outcome but I just don't think enough to get to 6%. I could be wrong and hope I am.
Verity do you know if there were any tweaks to the PIII that could possibly improve the outcome or was PIII the same with just a larger group?
I think the market will react negatively to the 661 results, but it shouldn’t. I think the market is looking for at least a 6% FEV improvement from 661 Phase 2, but I don’t think that is likely. And I think anything less will #$%$ the market because I think the market is seeing the Phase 3 of 661 as only beneficial if it will be able to reach heterozygotes, even though Vertex has already said that is a high risk proposition. I think its wrong to see 661 this way. Now, of course, if it does get to 6%, then I think the market should react extremely positive because I think that will be enough to get hetero past the 12 week futility analysis and I think longer term the heteros will have enough other benefits (i.e., weight gain and reduced excerbations) to get approval. But as I said, I don’t see the Phase 2 getting to 6% given the results of the initial Phase 2. But here’s why it isn’t negative: The quick move to Phase 3 for 661 will mean that the 661 trial will fill fast and thus a quicker approval. It will fill fast because 809 combo is not yet available for those in non U.S. countries (it will be soon in U.S.) Traffic and Transport beat even the most optimistic hopes for full enrollment and 661 could be similar, especially with the open label option. A quicker study and quicker approval will speed up the 3-drug combo approval process, which will get to heteros. So, even if the 661 results are less than 6% and not enough to get to heteros, that isn’t a negative...it just earth shattering positive, which it would be if it could reach heteros now. And anything over the 809 combo is great for all those for whom the combo works now. Keep this in mind during the close of March with the results expected any time.
Vertex’s patents do NOT prevent others from using Concert’s deuterated Ivacafter. For example, see the claims of Vertex U.S. patent nos. 7,495,103; 7,553,855; and 8,324,242. The claims in these patents do not cover deuterated analogs. In addition, the prosecution history of Concert’s patent covering deuterated Ivacafter (U.S. Pat. No. 8,865,902) was clean, with no obviousness rejections. That is because the patent contained data in the specification showing in vivo half-life improvements of up to 42% for deuterated Ivacafter analog 105. See Table 6 in column 41 of the ‘902 patent.
Bottom line – Concert has issued claims covering new deuterated chemical entities that will be difficult to challenge.
It would certainly be contested in federal court if the patent office ruled it a new entity. The court can over rule an initial patent office decision but often it requires a jury trial. Probably more cost effective for VRTX to buyout CNCE if D-Ivacaftor is a significant improvement over the original drug. That will take a few years to prove, and will be watched closely by VRTX management who know Roger Tung well from his years at VRTX.
Gladpick: You are right. I am not a patent lawyer. However I do know that in the past enantiomers of certain drugs had been patented as a new chemical entity. If you do not know what I am talking about, then you know less than I do. The question remains whether the deuterated Ivacafor be considered a new chemical entity.
If you look up the home page for EIP Pharma you'll get some background on the Connection of EIP, whose CEO is John Alam, MD, (oldtimers on this board may recall; he was a formrer CMO at Vertex prior to the development of telaprevir). Vertex has licensed VX 745 to EIP since 2012 and evidently is making some progress in applying it to treat inflammation in the CNS to see if it has any clinical benefit in neurologic diseases like Alzheimers. Vertex program to treat neurologic disease or injury has much greater depth and progress than most investors appreciate for spinal cord injury, Huntington's, chronic MS, pain, and Alzheimers . Thanks Rojo for this update.
EIP pharma has licensed this drug from VRTX and they are starting a phase 2 a trial in VU medical CTR in Amsterdam. Does any one remembers or knows VRTX deal with EIP? Drug basis for AD look very attractive.
I think Cethrin is very exciting for acute SCI. C5 level is the most common after MVA and data in 40 patient study published in Journal of Neurotrauma with C4-C7 is very interesting. Combining Cethrin with Acorda or NVS drug will not be a bad idea.
"Does the patent for Ivacafter protect against someone using deuterated Ivacafor?"
Yes it does. Apparently, you do not know much about patent laws. The only time a compound can be altered and sold as an improved version without the patent holder 's permission is when the patent has EXPIRED. An example is NKTR-102 is an improved version of Irinotecan whose patent expired a while ago and now is a generic drug.
It didn"t SELL the news so definitely positive waiting for 661 results of the 12 week trial and early approval...
Sentiment: Strong Buy
Does FDA ever send out any approval after 8pm, or 6pm? Just curious. How often do they miss the PDUFA date by several days? Heard that FDA likes to approve on Fridays. Could it be this coming Friday? I am kind of surprised that FDA missed the due date.
Its not ridiculous at all. Insurance already pays tens of thousands a month to keep CF kids alive and it gets worse and worse. Kalydeco will halt the progress and allow reduction in other meds and keep them out of expensive hospitals. The math says its worth it.
Sentiment: Strong Buy
" to the combination of lumacaftor and ivacaftor. We submitted the NDA and MAA in the U.S. and EU respectively in November 2014 that children and adults with CF ages 12 and older who have 2 copies of the F508del mutation. In the U.S. we received priority review with the PDUFA date of July the 5th 2015.
In the EU we were granted accelerated assessment and we anticipate EU approval around Q4 of this year if discussions with regulators progress as expected. All in regulatory approval in the EU individual reimbursement discussions will begin on a country by country basis....
scalped this from their Conference Call in January.... the other question for me post this Phase 2B 12 week study when will they raise cash for 2016 events... I am long since $87.00
Sentiment: Strong Buy