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MRK’s 3-DAA HCV regimen fails to impress: #msg-126517784.
ENTA presents preclinical data for NASH compound, EDP-305 at AASLD:
#msg-126481843
ABBV/ENTA report 8w Glecaprevir/Pibrentasvir phase-3 data from three trials:
#msg-126481635
3Q16 Viekira sales $378M, -10% QoQ: #msg-126121950.
Musings on GILD’s POLARIS studies of 3-DAA HCV regimen:
#msg-125928919
Second generation direct-acting antivirals – Do we expect major improvements?
http://www.journal-of-hepatology.eu/article/S0168-8278%2816%2930331-2/fulltext
Detailed and objective.
We will see what data gets added to this at AASLD
It won't be long before the late breakers get listed.
Some of the blanks may not be filled in until the actual presentations and final data are presented.
ENTA-related excerpts from C&EN NASH article: #msg-125551256.
Per the AASLD abstracts, I am seeing high cure rates w/ the ABT 493/530 doublet. I am also seeing that latter stage trials are including the compounds, co-formulated.
The genotype 3 data looks really good; lets just say that it would be difficult to improve a G-3 treatment naive without cirrhosis cure rate.
The G-3 naive w/ compensated cirrhosis was good but being studied in 16 weeks of TX, in order to get it closer to the non-cirrhotic results.
I'm uncertain as to how much is permissible to post
By the way... the MRK triplet data looks really good, except for AE events.
I think I see Gilead market share erosion. Market agrees this morning.
ABBV/ENTA's second-generation HCV regimen gets FDA BTD for GT1 DAA-treatment failures:
#msg-125491435
ENTA presents ex-vivo data on lead RSV candidate:
http://finance.yahoo.com/news/enanta-pharmaceuticals-presents-data-novel-200600789.html
ENTA starts phase-1 trial of EDP-305: #msg-125454754.
First 8-week V-Pak data shows 98% SVR12 in treatment-naïve GT1b patients:
#msg-125342507
Slide set from Morgan Stanley webcast on 9/12/16:
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyMzYyODd8Q2hpbGRJRD02NDU0MzI=
Baird Q&A presentation
http://wsw.com/webcast/baird46/enta/index.aspx
Yup; I've seen it in two forums. 3 pills is what I have read.
I don't know the rules about reformulating it into 1 pill, but the dosage suggested it could all be combined into 1 pill
I don't follow it either; I'm just reporting
" My only side effect was insomnia and I don't know the drugs caused it. I took 3 pills a day for 12 weeks. I've been virus free for 5 weeks. They don"
I was looking for a second post from another forum. I think it was 3 also
I don't understand why ABT-493/ABT-530 would consist of three FDC pills. We talked about the rationale for using two identical FDCs in #msg-123225583.
Ah Good! I'm half surprised. They have really guarded the terms of it.
The cyclophilin inhibitor *could* produce what may be record log drops. It seems to do so comparatively invitro. What would the market think if it saw a 5-6 log drop in monotherapy in the trials?
Rocky wrote;
Milestone payments will make it even more like a bank. The higher royalty payments will be meaningful if market share goes up. Since expenses are increasing, royalties and sales will have to go up for any real income to fall to bottom line. We "know" US sales of V-Pak will be down significantly in 3rd (and probably 4th) quarters. Probably not a huge deal since they already so low. Only hope until next generation is increased Japanese sales, but didn't do much for this quarter (increase of $1MM of royalties). More than ever, this is a next generation story and, with the overall HCV market going down, ENTA needs to get double or triple the current market share to be meaningfully profitable. Not impossible, but seems unlikely. Hope that I am wrong.
$80M of milestone payments are coming for next-gen HCV regimen (in addition to higher royalties).
"Revenue for the three months ended June 30, 2016 was $14.0 million, compared to $11.6 million for the three months ended June 30, 2015."
Shouldn't Enanta Pharma's charter be changed to a bank? Not much revenue, unfortunately..
ENTA had $244.7M of cash at 6/30/16, a decrease of $900K relative to 3/31/16:
http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2193820
Viekira sales by calendar quarter: #msg-124189583.
Dew -
1. Why hasn't ABBV been able to sell more of their HCV drug, relative to GILD's sales?
2. Do you believe the newly approved once-per-day pill will make any difference in sales?
3. Do you believe ABBV will be able to compete better with their next-gen drug?
Thanks Dew.
FDA apparently approved the once-daily formulation of Viekira Pak, called “Viekira XR”:
#msg-124098379
CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir table...
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ENANTA PHARMACEUTICALS INC (NASDAQ:ENTA)
Intraday Stock Chart
Today : Monday 25 July 2016
Click Here for more ENANTA PHARMACEUTICALS INC Charts.
NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.
"Through optimizing the use of VIEKIRAX, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."
Chronic HCV affects more than 160 million people worldwide,4 with 34 million people living with GT4 HCV infection.3 In Europe, where nine million people are infected with HCV,2 GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain, where prevalence rates from 10 to 24 percent have been reported.3
The CHMP positive opinion is supported by data from a dedicated Phase 3 AGATE-I study of GT4 HCV infected patients with compensated cirrhosis. The randomized, open-label study evaluated the safety and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from the study showed that with 12 weeks of treatment with VIEKIRAX and RBV, 97 percent (n=57/59) of patients achieved sustained virologic response at 12 weeks post-treatment (SVR12 ).1
"Until recently people living with genotype 4 chronic hepatitis C had limited treatment options," said Tarik Asselah, M.D., lead study author and professor at Université Paris Diderot. "If approved, this 12-week treatment would mark another step forward in the cure for GT4 patients, allowing difficult-to-cure patients with compensated cirrhosis to be treated in half the time with VIEKIRAX, representing a significant benefit for both them and their physicians."
Results from the AGATE-I study also showed that patients treated with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61) SVR12 rates. The most commonly reported adverse events (≥20 percent) in the 12-week arm were asthenia, fatigue and headache (18 percent, 17 percent and 23 percent respectively); and for the 16 week arm were fatigue, asthenia, headache, anemia, nausea, and pruritus (33 percent, 32 percent, 23 percent, 23 percent and 20 percent respectively).1 One patient in the 12-week group experienced virologic breakthrough and one discontinued prematurely after the first day of treatment. One patient missed the post-treatment week 12 visit in the 16-week group.1 The full study results were published online in The Lancet in June 2016.
About VIEKIRAX®
VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection. VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily.
Currently, in GT4 HCV infected patients VIEKIRAX with RBV is taken for 12 weeks, except in patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A4 substrates or strong inhibitors of CYP3A4. Do not give VIEKIRAX with strong or moderate enzyme inducers.
Special warnings and precautions for use:
VIEKIRAX is not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations:
Transient elevations of ALT to >x5 ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX and dasabuvir with or without ribavirin and more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin:
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products:
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without dasabuvir is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions:
Most common (>20%) adverse reactions for VIEKIRAX and dasabuvir with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Asselah T, Hezode C, Qaqish R. et al. Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial. The Lancet Online. Accessed 22 June 2016; http://www.thelancet.com/pdfs/journals/langas/PIIS2468-1253(16)30001-2.pdf.
2 Hatzakis, A. et al. The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference. Journal of Viral Hepatitis, 2011; 18 (Suppl. 1):1-16.
3 Khattab MA, et al. Management of hepatitis C virus genotype 4: Recommendations of an International Expert Panel. J Hepatol. 2011; 54: 1250–1262.
4 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
FY3Q16 earnings on 8/8/16—CC at 4:40pm ET:
http://finance.yahoo.com/news/enanta-pharmaceuticals-host-conference-call-113000022.html
Note: ABBV’s 2Q16 earnings and CC are on 7/29/16.
Epclusa is mainly for GT3: #msg-123576073.
FDA approves first pill to treat all forms of hepatitis C
The Food and Drug Administration approved the combination pill, Epclusa, from Gilead Sciences for patients with and without liver damage.
Read more: http://www.cnbc.com/id/103751499
ENTA begins EDP-494 dosing in GT1/GT3 HCV patients: #msg-123405434.
Market has no love for ENTA right now.
Nitpick: Since ENTA uses an Oct–>Sep fiscal year, evaluating results on a calendar-year basis can be misleading. For instance, ENTA’s guidance for the tax rate is set according to expectations for the full fiscal year.
Jay Luly exercised and held 25K options today: #msg-122543374.
ENTA had $245.6M of cash at 3/31/16 (a reduction of $8.9M relative to 12/31/15):
http://finance.yahoo.com/news/enanta-pharmaceuticals-reports-financial-results-200200117.html
Well, it's been a brutal few days. : )
One could get discouraged.
In mid june Gilead should get Sov/Vel approved,
and we may get a read out on the Abbvie 2nd gen program by summer....perhaps.
So there may be better days ahead for GILD, and the potential for the Abbvie 2nd gen may improve ENTA's current slump.
Merck has been ruining Gilead's and Abbvie's picnic near term.
What does their long term game look like?
http://www.natap.org/2016/EASL/EASL_38.htm
This is their triple therapy; 8 weeks.
How does it stand up to Gilead's double or triple therapy?
How does it stand up to Abbvie's 8 or 12 week 2nd generation doublet?
Keep in mind.....
These 8 week values are for treatment naives; not even exposure to IFN
Dew, I expect you misquoted me as I doubt I said the death of ENTA as I'm long....
You announced the death of ENTA on this board last October. Don't make the same mistake again.
This stock is sure being ripped apart for a company that has a three year run way.
Enta, Abbvie, Gilead, post earnings release.
Enanta has dropped from an opening thurs ($30.60) AM to a friday close of $29.19 on sub average volume.
Gilead opened at $99.61 on thurday and closed friday at $88.21 (on nearly triple volume)
In spite of Gilead dominating at EASL, how can it be it has fallen roughly 10% in 2 days?
What are the prospects for ENTA?
How are they as they relate to the Gilead HCV program(s)?
I highlighted interesting parts of the Gilead transcript
(apologies for length)
http://seekingalpha.com/article/3969438-gilead-sciences-gild-john-f-milligan-q1-2016-results-earnings-call-transcript?page=1
(milligan p. 2) "And in fact, we have treated close to 1 million patients with Sovaldi-based regimens since Sovaldi was first approved in late 2013. That's a remarkable achievement in just over two years."
Paul Carter on most of the following quotes;
"This was primarily driven by the continued opening of access across payer segments to allow for the treatment of patients with lower fibrosis scores as well as an increase in treatment by the VA during the second half of the quarter, as funding made its way to the various VA sites." (page 6)
For the Abbvie program fewer cirrhotics treated may mean greater share. In addition, Abbvie is now roughly 100% SVR rate in G-1b, even in C/P-A cirrhotics, riba free.
"The ability to treat for eight weeks notably is a strong competitive differentiation." (Page 6)
This should bode well for the Abbvie 2nd gen program.
"Qualitative feedback suggests that prescribing HCV physicians are encouraged by the fact that real-world outcomes mimic the experience in clinical trials. Several presentations of real-world data at EASL reinforce what has been seen in clinical practice" (page 6)
Those real world results also were very good for Abbvie; perhaps better since some thought it to be an inferior treatment to Gileads in G-1
"Despite the number of patients treated to date, there are still over 3 million patients in the U.S. who have yet to be treated. About half of these patients are undiagnosed."(page 6)
Plenty of market yet in the USA
(Japan) "30,000 patients were treated with Gilead products during the quarter, representing a market share greater than 90%." (P. 7)
NOT good news for Abbvie/ENTA 1st gen, although it could pick up. It should take some time to draw down.
I continue to wonder if once daily Viekira will be submitted/approved in Japan.
"so many different genotypes in China. Genotyping is not common in China, and this could provide a very good option for the people of China. So there's hope, but we can't guarantee of course that we can accelerate that approval beyond its current timeline, which is 2019".(p.11)
I have to wonder how much SOV/VEL with beat the Abbvie 2nd gen program in China; a year, 16 months?
"sofosbuvir/daclatasvir is a very expensive regimen. And the hope is that the cost of the genotype 3 treatment will come down somewhat after sof/vel comes onto the market, which is the PDUFA date is June 28." (p.11)
I see that combo diminishing in the USA w/ SOV/VEL approval. Abbvie 2nd gen will be quite comparable to SOV/VEL in efficacy and tolerability.
(this is really key, I thought)
"And then on the negotiation side, I think with real-world data, payers are tending now to really take a lot more time and put a lot more thought into evaluating the clinical profiles of the products. And until we see the clinical profiles of the new products, it's very hard to predict how competitive they are. If they're competitive, I think we have to anticipate prices will come down and we'll negotiate because we certainly don't want to lose any access to patients for our products, and we'll defend our market share vigorously." (14)
Perhaps referencing the Abbvie 2nd gen, which had a larger data reveal than merck or JNJ.
=========================
(my comments)
Gilead is going to see increased competition from Abbvie I think;
Abbvie/ Enta 2nd gen program is
Riba free
Once a day program
Pangenotypic
Tolerable + low AE;
Seems suited to other difficult treatment sub-groups
I'm not sure that the Gilead will be seen as superior, hands down. It may not even be as good as the A&E 2nd gen in some respects.
There is a lot of market left, but probably only for the best drugs; the bar seems to continue to be raised. Will other drugs fall off like Teleprevir did?
R. Gonzales said that Abbvie didn't cut the Viekira price drastically; I get the feeling that Gilead also tried to hold the line. MRK didn't; why?
I wonder if Merck is just getting what they can. I'm not sure they have a triple therapy that will be competitive; so they are getting what they can now, with what they've got.
Neither Gilead or Abbvie want to lower prices, because they have viable 2nd (or 3rd) gen programs. Maybe Merck doesn't care cause they aren't a long term player (I dunno; I wonder)
The price of sovaldi must stay high; it discourages other bolt on therapies from competitors, like daclatasvir or Merck doublet
.....and....
with the approval of SOF/VEL, I'm trying to think of the need for single agent sovaldi after approval (other than as a bolt on for competitors)
What do I think about the Gilead prospects?
The estimate a few years back was 180 million people in the world.
They have treated 1 million patients w/ Sovaldi based therapies.
I think that they may share more patients w/ Abbvie in the future, but I don't see them losing the lions share anytime soon.
I think it signals that there may not be any more $11 billion dollar HCV drugs buys in the near future. : )
Then again..... what if there was a drug that could replace GS-7977 (sovaldi), or had equal importance to Gileads nuke?
So far as ENTA.... IF the cyclophilin inhibitor were to be effective, it could end up replacing Sovaldi as the one compound needed in all treatments, or it could become a great partner for the (or a different) nuke.
What IF two compounds could treat all genotypes, sub-groups (TE, cirrhotics, etc) and in a shorter dosing period?
Viekera sales:
Q1 16 US: 125m Intl: 289m Total: 414m
Q4 15 US: 197m Intl: 357m Total: 554m
Hmm - doesn't look that promising. Thoughts?
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