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ECYT with two positive events today
ENDOCYTE ANNOUNCES PHASE 2B TARGET TRIAL RESULTS EVALUATING VINTAFOLIDE/DOCETAXEL COMBINATION IN NON-SMALL CELL LUNG CANCER (NSCLC) MET THE PRIMARY ENDPOINT OF IMPROVED PROGRESSION FREE SURVIVAL
http://investor.endocyte.com/releasedetail.cfm?ReleaseID=834444
Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT® (vintafolide) and Companion Imaging Agents FOLCEPRI® (etarfolatide) and NEOCEPRI® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant Ovarian Cancer
http://investor.endocyte.com/releasedetail.cfm?ReleaseID=834442
Congrats on your ENTA call. Today's slide aside, it has increased appreciably since fall of 2013.
Overall GILD's pricing decision seems to be bullish for ENTA. Was there anything overly bearish from what GILD said yesterday at all? Perhaps requesting an 8wk label but even that appears to have a silver lining for ENTA.
The ICPT valuation discussion is an interesting one. From some of the articles I've read it appears that the NASH market is not that well understood to know that the ICPT drug would work on most NASH patients or even the most severe ones that analysts seem to think the drug would be ideal for. The data from the P2 trial is not that detailed. Given the scarcity of data at this point is an ~8B valuation justified? HGSI was a stock where the initial assumption was that it could be used on a large number of SLE patients and the stock traded at ~7-8B before being sold to GSK eventually for half of that valuation. Though comparing with the VRUS and VRTX valuations and NASH prevalence the current ICPT marketcap still seems to be a bargain provided the drug has no hidden quirks and it does work on the majority of the NASH patients.
There are quite a few trials including these two recent ones which tests a minimum of 12 weeks and go upto 24 http://clinicaltrials.gov/ct2/show/NCT01962441?term=Sofosbuvir+24&rank=1
http://clinicaltrials.gov/ct2/show/NCT01965535?term=Sofosbuvir+24&rank=5
At this point is it safe to assume GILD's Sofosbuvir does not have the risks associated with similar nucs like that from INHX/BMS? Will the safety factor be a concern for some physicians especially if the regimens are longer than 12 weeks? I wonder if there is whether it could lead some physicians to ABBV/ENTA regimen.
ENTA would only get about ~3.3 % of revenues at the lower end (1/3 of low double digits) and about 6.67% at the higher end of the royalty stream. Though since some of the treatment regimens include only 2 DAA's I wonder if ENTA could persuade ABBV to part with more citing greater treatment effect from ABT450. Doubtful i think.
How important is it that the accelerated approval was for the 45 mg dose and ARIA is now switching to 15/30 mg?
Very interesting. Most striking part for me was when Dr June mentioned that the approach could be used for other areas like infectious and autoimmune diseases. Novartis could have a stranglehold on the pharma industry if that happens. I don't have a medical background but training Tcells sounds a bit like what Dendreon already does.
When he talked about a cure for cancer the movie "I Am Legend" came to mind. Hope in real life the outcome is different.
Thanks for posting this. Has ENTA ever disclosed whether the milestones are tied to any special circumstances such as first to approval or being part of a 2 DAA instead of a 3 DAA? Would they have to disclose it if they haven't already?
FWIW I was trying find any precedence of an FDA approval based on a single positive trial in the neuroscience area and couldn't find any. If the FDA does consider PDP an unmet area then maybe things will be different this time.
The ACAD story, upto this point, appears to be very similar to the HGSI story. Both companies with drugs considered by many to be no better than a sugar pill and they both designed trials to show efficacy. A very lucrative bet for those who kept an open mind and were aware of the risk/reward.
Interesting story to watch if Pimavanserin does end up like Benlysta.
Also mentioned was the PROC trial with VTX2337, the lead compound for VentiRx. The PR notes that the compound is partnered with CELG and not with ARRY. I need to read up on what the terms are.
http://www.ventirx.com/assets/pdfs/Final_GOG_Press_Release.pdf
ARRY- It's notable that there is no mention at all of Selumetinib in BRAF-mutant Melanoma.
RIGL - I think you meant the first P3 event. The first readout should be from the P2 mono trial for DMARD naive/intolerant patients. Its against Humira so its a tough hurdle.
The MOS for the erlotinib control arm is assumed to be 7 months. So unless they have sicker patients in the trial the alternative has to be bearish if the interim is much earlier than expected.
ARQL - The CEO noted that they had reached the number of events for an interim look about two months ago. Do you happen to know if that's ahead of schedule? They should probably be announcing the interim results soon.
I only see two presentations on their website and neither of the trials involved with the presentations used 60mg. One used 40 mg on a small population (24) so I would think most would be skeptical of extrapolating data for the 40mg dose to the 60mg especially with a small n. Plus the Zytiga/Xtandi failures are with the 100mg dose. In fact if they did test the 60mg dose they didn't publish the data. The previous 60mg results (if they exist) are not even mentioned on the recent 10K. If there is anything recent that you are aware of please post it.
EXEL-
Mylan Launches Generic Actoplus Met® Tablets and Generic Actos® Tablets
-Company granted 180 days marketing exclusivity on both products-
PITTSBURGH, Aug. 17, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg. Previously, the company also received final approval from the FDA for its ANDA for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15 mg/500 mg and 15 mg/850 mg. These products are the generic versions of Takeda Pharmaceutical Company's Actos® Tablets and Actoplus Met® Tablets, respectively, and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.(1) The FDA has awarded Mylan 180 days of generic marketing exclusivity on both of these products.
http://investor.mylan.com/releasedetail.cfm?ReleaseID=701000
BCX5191 is preclinical and it looks like the Medivir drug is in the same state. I think the FDA may be looking at drugs that may be in P1/P2 state.
Since the board appears to be focused on PPHM today, is Bavi a nuc and if not is the IDIX news positive for Bavi:)
It will be interesting to see how Squarer compares with Conway when it comes to partnering. Conway was pretty impressive IMO. When he said a partnership was coming he delivered. I remember before the Amgen partnership he said something along the lines of signing something within a matter of weeks and lo and behold he did. Hopefully Squarer is equally reliable. I think the 2008 or 2009 10K was equally descriptive about 797 but for some reason they shelved the drug. With all the question marks surrounding P38 inhibitors it may be a tall order to get a lucrative deal done so hopefully Squarer isn't setting up everyone for disappointment down the road. I think the focus should probably be on 614 and the MEK's and perhaps the GKA.
Thanks for the link. None of the candidates from the table appear to be in development according to information on clintrials.gov and the companies websites. AZN, Roche and Lilly appear to be focusing mostly on SGLT2 inhibitors and DPP4 inhibitors.
I get 6 results when i search for glucokinase on clintrials.gov.
Searching for SLGT2 returns 19 results and DPP4 505 results.
Do you like AMG 151 because it is a GKA? I'd be interested to know what specifically you like about it? Only early P1 data is public as far as I know and you seem to be skeptical about early data. Lilly terminated a GKA trial a while back for what appears to be safety reasons.
ARRY - I gather that one reason for the positive reaction could be that the PR states that there could be a P3 for selumetinib completed by 2013. That's intriguing if I understood it correctly. Sounds like a small trial powered for PFS if true. Do you recall this being addressed during the CC?
Thanks for the link. I missed that post.
Intriguing information about the CRP level returning to baseline after a few weeks. The CRP level is tied to inflammation if I understand correctly so that probably means that with 797 a longer treatment period is warranted to ensure the treatment effect stays. Is that read correct?
It looks like Virtex had a P38 program until 2007 and then they shelved it. They too saw QT issues in their trials but nothing significant. They also reported some liver issues but those too weren't significant. The P38 MAPK inhibitors in general appear to have safety issues so the conclusion appears to be that developing them for inflammation will be costly. Given that Virtex was unable to find a partner I doubt ARRY will find one but perhaps they've got a better compound that the Virtex one.
Why genentech and roche in particular? Both companies already have drugs for BC and Melanoma either on the market or in trials. Since CDX011 has already been tested for both those two indications, they are probably the quickest to market. Why wouldn't another pharma with unlimited resources albeit less exposure to oncology development that wants to have a drug for BC and Melanoma not be a better partner? Chances are that with Roche and NVS CDX011 would be buried behind TDM1 and Afinitor and CLDX would be stuck with a small upfront and a partnered drug that won't earn revenue for years and years.
ECYT - Interesting that the targeted approach has the potential of being used for PKD. Here's more on the topic.
http://www.futurity.org/health-medicine/new-drug-targets-common-kidney-disease/
EC371 is not on the pipeline chart and not even mentioned in the 10K so it's a long way away before it hits the market, if at all.
Do you have a link other than a tweet? Thanks.
You're assuming whoever tweeted that is correct. Here's one of the 189 trials. Perhaps it was in the non-daclatasvir arm. I don't recall cardiovascular issues being a side effect of ribavarin.
http://clinicaltrials.gov/ct2/show/NCT01425970
HALO - Has HALO/Roche ever discussed when they would be filing Herceptin/Mabthera in the US? Thanks.
HALO - While the safety concerns are less of an issue for oncology and other terminal indications, how likely is that the FDA will be satisfied with pre-clinical data and not long-term data? As others have pointed out, the SC use is a convenience and not a life saving product. Herceptin and Mabthera can still be given through IV.
ARRY - I suppose another reason could be that since 614 is a p38 inhibitor as well there could be similar Qtc observations seen. Obviously that would not be a serious concern given that MDS is more severe.
ARRY - The melanoma data was expected end of june according to one analyst so i presumed the run up was due to that. I'm surprised the pain trial results caused a 15 % drop. The only reason I can think of is that 797 is fully owned and perhaps there was the possibility that it could also be faster to market than any of the other drugs.
I agree with your sentiment on IDIX. Some of its current valuation is perhaps tied to a buyout similar to INHX. Would another pharma be willing to shell out billions and have the deal blow up like BMY did? Well, presumably its blown up.
HALO - Around the 16.30 mark the first analyst asks about the EU application status for Herceptin and Mabthera.
It's not clear from the call what the relationship is between a plasma derived product and elevated non-neutralizing antibodies. It appears that the FDA is concerned that the combination of the plasma derived products and rhuph20 causes the elevation but it's not clear why. Is it likely that the treatment duration with rhuph20 is the reason for the elevated levels of the antibodies? Both HyQ and Cinryze probably have longer treatment durations. I think it was mentioned during the call that the % of antibodies increased for the other products as well but the % was smaller compared to HyQ and Cinryze.