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What's your take on it? The second option (stunning data)?
5/22 Rx #s
V-Pak: TRx@ 955 NRx@ 454.
Sovaldi:TRx@ 2,220 NRx@ 885.
Harvoni: TRx@ 9,982 NRx@ 4,393.
Olysio: TRx@ 205 NRx@ 61
So apparantly some people actually do take v-pak, comply with the pill burden for 12 whole weeks, don't croak from the side effects and actually get cured!!! Who would have thunk it!! :)
http://hepcfriends.activeboard.com/t59659874/all-aboard-for-the-viekira-pak-treatment-train-enjoy-the-rid/?page=1&sort=newestFirst
On a little more serious note, it's great to see all the success stories from Harvoni and V-pak from these boards.
Similar to how last year Mark Schoenebaum predicted MRK would have a hcv drug on the market in mid 2015 :P
LOL. Lighten up Jbog. I thought it was pretty funny.
Catch the Rx #s per chance? My friend with bloomberg access isn't around today so haven't seen yet.
Also of note from either the CC or the DB conference (I forget which) is they have really ramped up hiring for their new compounds.
That was kind of my thinking on the whole thing. Maybe he's just playing conservative since Q1 was under $250m and is just assuming Q1 #s as a base for Q2. Or it really could be somwehre b/t 500 or 1b. Or it really is $1b :) Time will tell I guess, but for the heck of it I'll say that the next tier is somwehere b/t 500-800
So that's a $40m market cap loss today on $6m under revenue. :P
I'd guess the 3% guidance for Q2 isn't helping, but overall the drastic drop seems a bit silly but pretty used to it by now.
Any chance MRK goes the same route? ;)
Props to you for predicting this. Pretty sure you were one of the first of not only commenting about BMY not submitting.
Kind of funny analysts still think MRK gets approved late this year still even those it's May 6.
Jbog,
I don't think it can get any more clearer than below. What is the problem here?
http://2lveuw1712z73k1mcp188o8b.wpengine.netdna-cdn.com/wp-content/uploads/2014/12/BN-GC663_abbvie_P_20141219231240-Viekira-Pak-from-AbbVie.jpg
425 NRx 798 TRx it looks like
Maybe simplistic, but jumping from a 3-4% Rx share in Q1 to a 10-15% one in Q2 will be a pretty big jump for v-pak earnings, no?
Have you seen symphony #s for the week? TIA
~260,000 patients or 4% of the estimated 6.6 million infected population (U.S. ~4.0 million and Big-5 ~2.6 million) have been treated with a sofosbuvir-based regimen since December 2013.
Plenty of market left according to GILD.
GILD - $4.55B HCV Sales. Yowza.
Busy day for Luly. Speaking at the DB conference at 2:10pm on the same day. Wonder why they scheduled the end of quarter call like that.
CS seems to think MRK has the edge over ABBV now.
https://pbs.twimg.com/media/CDn1X2zW0AA9-cN.jpg:large
ENANTA PHARMACEUTICALS ANNOUNCES PRELIMINARY DATA FROM ABBVIE’S PHASE 3B RUBY-I STUDY IN CHRONIC HEPATITIS C PATIENTS WITH RENAL IMPAIRMENT PRESENTED AT THE INTERNATIONAL LIVER CONGRESS™ 2015
In preliminary data from RUBY-I, patients receiving VIEKIRAX + EXVIERA with or without ribavirin who reached post-treatment week four (n=10 of 20 enrolled) achieved 100 percent sustained virologic response at four weeks post-treatment (SVR4)1
Treatment regimen evaluating VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) contains Enanta’s lead protease inhibitor, paritaprevir
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 25, 2015-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today new preliminary safety and efficacy data from the first cohort of AbbVie’s ongoing, Phase 3b RUBY-I study. RUBY-I is evaluating the regimen of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12). The first ten patients, or 100 percent, who have reached post-treatment week four to date (n=10 of 20 enrolled) achieved SVR4 (n=10/10).1 The RUBY-I study was presented as a late-breaker today at The International Liver Congress™ (ILC) 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
“We are encouraged by this promising data in this difficult-to-treat patient population,” stated Jay R. Luly, Ph.D., President and Chief Executive officer. “We look forward to the final data from this and other studies that AbbVie is conducting in special populations.”
RUBY-I data showed no virologic failures to date.1 Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events when receiving VIEKIRAX + EXVIERA with or without RBV, most commonly (> 20 percent) anemia, fatigue, diarrhea, nausea, dizziness and headache.1 To date, eight of 13 GT1a patients had a RBV dose interruption.1
Paritaprevir, Enanta’s lead protease inhibitor, is one of the three direct-acting antivirals (DAAs) included in AbbVie’s HCV treatment regimens approved in the U.S. for genotype 1 chronic hepatitis C virus as VIKIERA PAK®, in the E.U. as VIEKIRAX® + EXVIERA®, and in Canada as HOLKIRA PAK®. AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir.
Additional Phase 3b studies from AbbVie presented at ILC 2015 included MALACHITE-I and MALACHITE-II data, and TOPAZ-I and TOPAZ-II study design. The MALACHITE studies evaluate adult patients with GT1 chronic HCV infection without cirrhosis receiving VIEKIRAX + EXVIERA with or without RBV compared to treatment with telaprevir with pegylated-interferon and RBV, which remains the standard of care in many regions of the world.2,3 The TOPAZ studies will evaluate the effect of SVR12 on long-term outcomes five years following treatment with VIEKIRAX + EXVIERA with or without RBV in adults with GT1 chronic HCV infection.4
Looks like the market is catching on
Thanks Rocky. Good points and agree that the drop was surprising.
All of MRK Data is out:
Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).1 Patients in both the HCV infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). In addition, HCV infected, treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively. These data were presented at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today.
“Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute and clinical professor of medicine, The University of Texas Health Science Center, San Antonio. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”
“At Merck, we continue to build upon our clinical experience using grazoprevir/elbasvir across diverse populations of patients infected with chronic hepatitis C virus,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “We remain on track to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of 2015.”
C-EDGE TN Overview and Additional Findings
C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42 percent with GT1b, six percent with GT4 and three percent with GT6. Overall, 22 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in nine (3%) and three (3%) patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively.
C-EDGE CO-INFXN Overview and Additional Findings
C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%).
C-EDGE TE Overview and Additional Findings
C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks.
12 week arms
Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.
In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%).
16 week arms
Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent with GT4 and four percent with GT6. Overall, 36 percent of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or other GT1, eight percent with GT4, and two percent with GT6. Overall, 35 percent had liver cirrhosis.
Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).
FWIW since some RXs are being blocked the avg NRx per week in Q1 from symphony was 288. The avg in April (2 weeks only) has been 488. Just going by that I think it's going to be pretty easy for them to at least double their US v-pak sales in Q2.
It looks like 8 week is probably as good/short as it's going to get.
21% of perferred market is under contract for ABBV ramping up in April & May and into 2H 2015 as you said
Would be nice if ABBV breaks out the $232m by month. I'd imagine the bulk of those sales came in March.
How so? If you look at April Symphony Nrx #s they are about 100% more than the Q1 avg. Pretty much all the medicaid deals didn't kick in until April either. Also, it seems ex-USA sales have picked up significantly faster than expected. Hitting $800m in Q4 doesn't seem that difficult. I'd bet a dollar they hit that with ease.
ABBV just reaffirmed $3b run rate by Q4
$138m matches up pretty well with Symphony Rx #s for Q1. So I wonder what happened to those 1000+ Rxs before Jan 15 ABBV management was chirping about... Surprising ex-US #s.
That 99% number is mITT. 94% for ITT (still good). guess it's okay to report SVR like this now?
MYL/TEVA up pretty big on TEVA buying out MYL rumor....That would sure make things even more interesting for Gx Copax
Correct me if I'm wrong, but MYL has previously stated that they have altered the NATCO indian Gx Copax.
Overall I think the FDA's approval response was about as bullish as it can get for MNTA by what they showed and equally as important what they didn't show
I really don't think investors are too concerned with the 40mg at this point. The price is capped (today at least) because there is no clarity around launch time and then we're also back to the competitor overhang like the enox days.
Will be curious to see how MYL responds.
On top of that, after going through the CP, the approval process just seems a lot more difficult/complicated than enox. This seems to be quite bullish for MNTA.
CW got his swagger back on that CC. Obviously, a must listen for all.