Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Curious they are presenting at such a small medical conference and could only get a poster presentation at ESMO....
OS will not be stat significant given 3 arms and only 40 patients per arm. Trends dont cut it in my book. Need to see baseline of patients between all arms.
They must have stacked their trial. Drug didnt work at all in 1st line NSCLC but magically works great in 2nd line?
To be clear, this is because it is in the same class of drugs as INHX's, not because of a signal in the IDIX trial
_____________
Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company received verbal notice from the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on IDX184, the Company's nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV).
As a result of the recent occurrence of a serious cardiac-related adverse event encountered with a competitor's nucleotide polymerase inhibitor for the treatment of HCV, the FDA has expressed an interest in further reviewing the safety of IDX184 and has placed IDX184 on partial clinical hold. In previous clinical trials as well as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are currently no patients receiving IDX184 worldwide.
The FDA has requested additional data on patients treated with IDX184. Patient safety is our main concern and Idenix will immediately begin work to comply with the FDA request and expects to submit these data to the FDA in the coming weeks. The Company intends to have an ongoing discussion with the FDA following the submission of this data.
I'd give it less than 10%. IMO, the meeting in June was the FDA signaling no NCE and AMRN protesting.
Thanks for the notes as usual
Thanks for the link.
Agree that the low separation between Oxy and placebo is somewhat surprising. Not sure what the dosing for Oxy was in this trial. I imagine the Oxy and 797 are fairly close, which is quite encouraging.
Hopefully ARRY's fantastic biz development team partners this in the next 6-9 months. Seems like an opportunity for someone with bigger pockets to explore in Phase 3 given the amount of data they have on this drug.
Yeah I dont get how the stock is green. I've heard some nonsense about how if the 5mg dose worked and were approved they could face some generic competition. However no one has actually laid out why the FDA won't consider pulling the drug.
When I spoke to them, they said they would like to partner out the worldwide rights.
- Extremely confident that it gets partnered.
- They said the SGEN deal might be a reasonable guide as to what to expect for their partnership ( like 60-70 mil upfront – high double digits royalty).
- Willing to give up a big upfront payment in order to not have to pay for development.
I think this is a smart move given the large number of trials they need to run, since you're talking combo trials, single-agent across different lines of therapy.
Do you really wanna go there? You and all of your constant pumping of PPHM has probably cost people more money than you can imagine.
Actually, no, I think it's criminal PPHM is still giving their drug to patients.
Never said that I expected not to help patients, just not enough to matter(statistically). Naturally, I agree with your statement.
Well I am expecting triple failure of all their trials this fall(NSCLC 1st & 2nd line, Pancreatic). I will be smiling then.
WoW PPHM up 500% in past month or so. Where is the boiler room on this one?
Really questionable decision making going on at EXEL. First they do trials in last line CRPC, now this disastrously dilutive financing. I think since Mike Morrissey took office as CEO in June 2010, he has ballooned the O/S by 33+%(from under 100M to well over 150M). Probably closer to 40-45%.
Pfizer says co-primary endpoints not met in second Alzheimer's trial in patients who don't carry ApoE4 gene
Pfizer discontinuing all other bapineuzumab studies after second trial fails
No, JQ's pointing out that ALS-2200 is a pyridimine, not a purine. ALS-2158 is a purine.
http://investorshub.advfn.com/boards/replies.aspx?msg=78018470
$MNTA Appeals Court vacates and remands district court ruling in Momenta vs Amphastar case
Sure seems like purines are striking out. First 938, now 189. Guess what else is a purine? IDX184.
A chemist pointed out that IDX184 metabolizes to the same triphosphate as INX189. INX189 shares similarities with 938 as well.
Something I might be a bit concerned about if long a substantial amount of Idenix.
I agree 100% on the suspect management for 2 reasons.
1- on BAX 2q call they said they expected a CRL soon, but no mention from HALO about this.
2- Roche said they were moving forward with MabThera etc, but again no mention of this by HALO
Not the kind of company I want to invest in. Clearly something was up and they chose to say nothing instead of act.
Actually the CRL is much worse because of the following paragraph that HALO gave. All of their programs are on hold now.
I agree that QT issues are largely overblown.
Here, I think it's not nearly as big of an issue as have been made. Study was at 400 mg BID. I dont believe this to be a class issue with the p38's and their previous 14-day study went up to much higher doses with no QT/cardio issues; also none in their molar extraction studies.
Intracellular Signal Pathways: Potential for Therapies
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3033497/
Array Phase 1 PLK/PD study
http://www.arraybiopharma.com/_documents/Publication/PubAttachment402.pdf
They said QTc was within FDA thresholds for this issue. You left this bit out
"To further explore the safety and tolerability of ARRY-797, Array is currently conducting a multiple ascending dose trial in healthy volunteers at doses up to 2.5-fold higher than those evaluated in the osteoarthritis pain trial. ARRY-797 has been well-tolerated in this trial to date, and greater QTc prolongations were observed at these higher dose levels. No subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia. These QTc observations warrant further evaluation."
IDIX $150M offering
wow, classy.
MAPP offering
I believe the oral Relistor NDA was going to rely on long-term safety data from this sNDA. I think the CRL could significantly delay this filing.
PGNX likely needs to raise some cash IMO. No approval cost them a $40M milestone and now they need more clinical data. It also delays oral Relistor filing. I will wait for an offering.
Re: AMRN/NCE
No, it's not.
It turns out that the NCE status given to enantiomers is due to an amendment to the Hatch-Waxman Act in 2007 that is specific to this case (enantiomers of previously approved racemates).
http://www.mondaq.com/unitedstates/article.asp?articleid=54784
http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm
Due to the legislation, it is a special situation that does not bear on Amarin at all.
The presence of a single NCE indirectly confers protection on the mixture. Its highly unlikely for DHA alone to get NCE.
Dr John Tucker's tweet is quite clear and concise on this issue.
SLXP/PGNX CRL. More clinical data.
There are a few exceptions(Qsymia and Korlym), but the FDA generally own PR's new drugs.
Gekkowire makes a great point that likely means AMRN did NOT get NCE.
"The fact that FDA did not issue a PR for $AMRN is troubling for NCE."
The FDA has accepted its NDA for Ravicti, a new treatment designed to lower the level of ammonia in the blood to treat urea cycle disorders (UCD) and hepatic encephalopathy. Hyperion has an October 23rd PDUFA date with the FDA and says it will start marketing the treatment in the first half of 2013.
This certainly wont help get people excited about HPTX
"The United States composition of matter patent will expire in 2015, without taking into account the patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Amendments.
Based on current projections, HPTX expects to receive an extension under the Hatch-Waxman Amendments, which would extend this patent coverage for approximately an additional three years to 2018."
Cornerstone Therapeutics Announces FDA Advisory Committee to Review Lixivaptan for Treatment of Hyponatremia
[ Submitting an NDA without ever disclosing the pivotal data from the trial supporting this NDA. Honestly, I think the company is kind of a scam. Their market claims are also outrageous given the very low level sales of currently approved vaptans. ]
Cornerstone Therapeutics Inc. (CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital, niche respiratory and related specialty markets, announced today the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) has scheduled a review of the New Drug Application (NDA) for lixivaptan (CRTX 080) for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The meeting is scheduled for September 13, 2012.
"Hyponatremia is a very common and complex condition, and we are committed to bringing lixivaptan to the market," said Craig A. Collard, Cornerstone's Chief Executive Officer. "Our team looks forward to discussing the data supporting the potential efficacy benefit and safety profile of lixivaptan with the committee and the FDA."
In March, Cornerstone announced the FDA's acceptance of the Company's NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012. The Company continues to work closely with the FDA during NDA review. Cornerstone acquired lixivaptan through its 2011 acquisition of Cardiokine Biopharma, which became a wholly owned subsidiary of Cornerstone.
Hyponatremia affects up to six million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually. Lixivaptan is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. Lixivaptan acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
The FDA will publish materials and details pertaining to the meeting at http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.
Unlikely to be commercially successful in combo with Nexavar. AE profile not great and efficacy not that much greater than Nexavar alone.
Spoke to a few KOLs who laughed at the idea of combining Nexavar and a drug like Tivantinib because the costs would be enormous.
What's current SOC in first line? Having one of those days.
Re PCYC/Ibrutinib
Have you looked much into this bleeding risk stuff?
The below blog post from July 7th seems to be part of the reason for the stock weakness past week or so. Fund managers getting a little nervous hearing stuff like 'intra-cranial bleeding'
http://updates.clltopics.org/4606-pci-32765-ibrutinib-what-we-know-thus-far
Re SNY/REGN
I wonder how much this trial is going to cost; I heard someone suggest it could cost close to $1b. Not sure how realistic that estimate is.
I think SPPI's physician loyalty argument is hogwash. If there was a steady supply of generic leuvo, docs would leave Fusilev for good.
The only reason they might keep this revenue is because generic leuvo prices are set so low, no real incentive for generic manufacturers to bring them back esp if the FDA is going to make them jump thru a lot of hoops.
Well, Leerink is wrong. I stand by my call that the FDA notified Amarin that there was problems with the NCE status, then Amarin requested this meeting to protest.
It is NOT a good sign. You think such a rare meeting with high level FDA legal reps is a good thing one month before the PDUFA over the status of exclusivity? I think not.
I dont question whether or not it gets approved, but I do question the NCE status. I think there is only about 25% chance Amarin gets it. Previous precedents do not apply here.