Intercept Pharmaceuticals (ICPT)

[DewDiligence]

PDUFA date for PBC extended 3 months: #msg-119252133.

[osaffer]

Why GNFT will take the Nash market
http://www.scribd.com/doc/293335048/The-Big-Picture-For-Genfit-NASH-diabetes-CVD

[DewDiligence]

ICPT starts phase-2 trial of OCA + Lipitor: #msg-118982377.

[oldsport]

no effect on stock whatsoever...

[osaffer]

Genfit Phase 3 Approved Breakthroug: 1800 Patients
Genfit on market in 2019 !

[DewDiligence]

Fibrosis-biomarker data from FLINT (presented at AASLD): #msg-118502898.

[oldsport]

buy rumor sell news...

[stocktrademan]

$ICPT recent news/filings

bullish 190.10
double bottom

## source: finance.yahoo.com

Thu, 12 Nov 2015 13:07:12 GMT ~ BioCryst and Intercept Drive Biotechnology Subgroup


read full: http://finance.yahoo.com/news/biocryst-intercept-drive-biotechnology-subgroup-130712709.html
*********************************************************

Mon, 09 Nov 2015 18:31:49 GMT ~ Edited Transcript of ICPT earnings conference call or presentation 9-Nov-15 1:00pm GMT


read full: http://finance.yahoo.com/news/edited-transcript-icpt-earnings-conference-183149861.html
*********************************************************

Mon, 09 Nov 2015 13:55:01 GMT ~ Intercept (ICPT) Posts Narrower-Than-Expected Loss in Q3


read full: http://finance.yahoo.com/news/intercept-icpt-posts-narrower-expected-135501407.html
*********************************************************

Mon, 09 Nov 2015 13:07:11 GMT ~ Myriad Genetics: Top Performer in the Biotechnology Subgroup


read full: http://finance.yahoo.com/news/myriad-genetics-top-performer-biotechnology-130711444.html
*********************************************************

Mon, 09 Nov 2015 12:36:38 GMT ~ INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Results of Operations and Financial Condition, Financial Statements


read full: http://biz.yahoo.com/e/151109/icpt8-k.html
*********************************************************

$ICPT charts

basic chart ## source: stockcharts.com



basic chart ## source: stockscores.com



big daily chart ## source: stockcharts.com



big weekly chart ## source: stockcharts.com



$ICPT company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/ICPT/company-info
Ticker: $ICPT
OTC Market Place: Not Available
CIK code: not found
Company name: Intercept Pharmaceuticals, Inc.
Incorporated In:

Business Description:

$ICPT share structure

## source: otcmarkets.com

Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available

$ICPT extra dd links

Company name: Intercept Pharmaceuticals, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=ICPT+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=ICPT+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=ICPT+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/news - http://finance.yahoo.com/q/h?s=ICPT+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/ICPT/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=ICPT+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/ICPT
DTCC (dtcc.com): http://search2.dtcc.com/?q=Intercept+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Intercept+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Intercept+Pharmaceuticals%2C+Inc.&x=0&y=0

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/ICPT
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=ICPT&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=ICPT
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=ICPT+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=ICPT+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=ICPT
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=ICPT
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=ICPT+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/ICPT/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=ICPT+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/ICPT.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=ICPT
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/ICPT/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/ICPT/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/ICPT
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/ICPT
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/ICPT:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=ICPT
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=ICPT



$ICPT DD Notes ~ http://www.ddnotesmaker.com/ICPT

[osaffer]

http://www.prnewswire.com/news-releases/a-large-prevalent-population-and-the-lack-of-an-approved-therapeutic-highlight-lucrative-market-opportunity-in-nonalcoholic-steatohepatitis-300176002.html

[osaffer]

BofAMerrill+Lynch+Downgrades

http://www.streetinsider.com/Analyst+PT+Change/BofAMerrill+Lynch+Downgrades+Intercept+Pharmaceuticals+(ICPT)+to+Underperform/11010828.html

[osaffer]

Causes

http://charts.stocktwits.com/production/original_44632096.JPG?1446124868

[osaffer]

Morgan Stanley Target Price ...
http://www.streetinsider.com/Analyst+PT+Change/Intercept+Pharmaceuticals+(ICPT)+Price+Target+Lowered+to+$110+at+Morgan+Stanley/11014655.html

[osaffer]

This is the end for ICPT

You should think to an other alternative ...

Japan results are bad!

http://seekingalpha.com/arti
cle/3618526-premarket-biotech-digest-intercepts-setback-takeover-talks-amgens-q3 -results?auth_param=k1v6r:1b343dk:0994c643364cef69f599b313b10f81e4&uprof=45

http://www.americanbankingnews.com/2015/10/28/intercept-pharmaceutica ls-stock-rating-lowered-by-bank-of-america-icpt/

[oldsport]

wow... wildride in a few hours time...

[DewDiligence]

ICPT -16%/PM on phase-2 NASH data in Japanese patients: #msg-118050513.

[osaffer]

- Professor Stephen Harrison will detail the beneficial effects of Elafibranor (GFT505) on
cardiometabolic risk markers of NASH patients:
“BENEFICIAL EFFECTS OF THE DUAL PPAR ALPHA-DELTA AGONIST, GFT505, ON HEPATIC AND
CARDIOMETABOLIC MARKERS IN ADULT NASH PATIENTS” SA Harrison et al. (Abstract 162)
- Professor Arun Sanyal will analyze the hepatic and extra-hepatic responses linked to the
treatment of NASH by Elafibranor:
“THE HEPATIC AND EXTRA-HEPATIC PROFILE OF RESOLUTION OF STEATOHEPATITIS INDUCED
BY GFT-505” A Sanyal et al. (Abstract 2145)

[osaffer]

GENFIT ANNOUNCES ELAFIBRANOR PRESENTATIONS
AND PRESIDENTIAL PLENARY AT THE 2015 AASLD
ANNUAL MEETING
? The results of the GOLDEN-505 phase 2b study of Elafibranor in
NASH have been selected for an exclusive oral presentation
during the Presidential Plenary session.
? Additional data from the Phase 2b study will be described in oral
presentations as well as in a poster session.


http://www.genfit.com/wp-content/uploads/2015/10/2015.10.02-PR-GENFIT-AASLD-2015.pdf

[DewDiligence]

ICPT starts phase-3 NASH trial called REGENERATE: #msg-117301781.

[DewDiligence]

Should be a modest positive, IMO.

[TSmith4659]

Dew, one more question. How is the news about RPTP's PII going to affect ICPT? Should their failure be a positive for ICPT? Thanks, have a good day!


TS

[DewDiligence]

ICPT has some buyout vig, but not from GILD, IMO. GILD is already committed to its own multifaceted NASH program.

[TSmith4659]

Dew, do you think ICPT is a buyout candidate? Who would benefit the most from their technology, GILD? What is it worth at this point? I just started following, I appreciate your views. Thanks


TS

[osaffer]

Genfit

Presentation Morgan Stanley Event

http://www.genfit.com/wp-content/uploads/2015/09/2015.09.15-GENFIT-Overview.pdf

[osaffer]

Wait for Phase 3 design for Genfit

ICPT is game over ...

http://www.genfit.com/wp-content/uploads/2015/09/2015.09.15-GENFIT-Overview.pdf

[DewDiligence]

Phase-3 REGENERATE trial in NASH posted on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT02548351

Note the exclusion criteria—especially items 3, 5, 9, and 13.

[osaffer]

BRIEF-Genfit announces positive results from its NASH biomarker program

http://www.reuters.com/article/2015/09/15/idUSFWN11L00420150915?type=companyNews

[osaffer]

OCA is only for PBC not NASH


Look at this !

http://www.genfit.com/pipeline/elafibranor/#.dpuf

[osaffer]

Nothing...
I was just sharing information with the board, about a wonderful company based in Belgium.

The potential is wonderful !

We are here to make money, nothing else ...

[DewDiligence]

PDUFA date for OCA NDA in PBC is 2/29/16 (with priority review):

http://finance.yahoo.com/news/fda-grants-priority-review-intercepts-110500232.html

[DewDiligence]

What does the Tigenix phase-3 trial have to do with ICPT?

[osaffer]

Genfit is great ... But there is also TIGENIX

http://www.wmcactionnews5.com/story/29920070/biolife-solutions-customer%20-tigenix-phase-3-clinical-trial-meets-primary-endpoint

[osaffer]

Genfit: Are you going to come here now ?

[osaffer]

For sure ... it is Genfit's Time !!!

You can hope to multiple your bet by 10 !

[Hfbiotechinvest]

Morgan Stanley starts Intercept coverage with only 165 target price...
Lipidic profile of OCA in question... Time to change strategy and consider alternative - and safer - drugs?

http://news.investors.com/technology/081315-766405-icpt-stock-falls-on-morgan-stanley-report.htm?ven=rss&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:%20InternetTechnologyRss%20

[osaffer]

http://seekingalpha.com/article/3332095-a-european-biotech-stock-basket-for-2015-an-update

[osaffer]

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)61198-9/fulltext

[osaffer]

FDA Expands Advice on Statin Risks

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm

[osaffer]

http://www.nature.com/nrd/journal/v14/n7/full/nrd4667.html

You should access and read ...

Phase 3 for Genfit with less patients ... 1500

[DewDiligence]

ICPT submits NDA for OCA in PBC:

http://finance.yahoo.com/news/intercept-pharmaceuticals-submits-applications-u-200500920.html

Although PBC is the lead indication, it’s a small market that’s much less consequential to ICPT’s commercial success than the OCA program in NASH.

[osaffer]

GENFIT : ELAFIBRANOR ACCEPTED AS THE GENERIC NAME FOR GFT505 BY THE WHO

GENFIT: ELAFIBRANOR ACCEPTED AS THE GENERIC NAME FOR GFT505 BY THE WHO
Elafibranor is unique and represents a new pharmacological class (first-in-class)


Lille (France), Boston (Massachusetts, United States), June 2nd, 2015 - GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that the World Health Organization (WHO) has accepted the international non-proprietary name (INN, or generic name) Elafibranor for its leading drug candidate previously referred to as GFT505.

The aim of the INN system is to provide health professionals with a unique and universal designated name for each pharmaceutical substance. This is important for the clear identification, safe prescription and dispensing of medicines to patients. In the INN system, the names of pharmacologically-related substances have a common "stem", enabling health professionals to recognize substances having similar pharmacological activity.

The new non-proprietary name, Elafibranor, reflects the first-in-class nature of the drug candidate, since it does not contain a pre-existing INN stem. The novel pre-stem "-fibranor" may thus become an established stem over time, as other later developed drugs are recognized to be related in structure or activity.

Jean-François MOUNEY, Chairman & Chief Executive Officer of GENFIT, declared: "We are very pleased that the INN division of WHO recognized the unique nature of Elafibranor/GFT505 by accepting the proposed generic name for our leading drug candidate. Moreover, their acceptance of the novel pre-stem "-fibranor" reflects the innovative nature of the drug candidate, and marks a new step in our overall development strategy in the run-up to the market launch of this first-in-class product."

About Elafibranor/GFT505:
Elafibranor is being developed for the treatment of NASH, and has recently completed a major international Phase 2b study in 274 NASH patients in Europe and the United States. Elafibranor showed significant activity on both NASH regression and liver fibrosis scores, as well as a significant improvement in cardiometabolic risk factors and an excellent safety profile. Elafibranor is expected to enter Phase 3 clinical trials in NASH at the end of the year.

[osaffer]

http://www.scribd.com/doc/261345016/Phase-IIb-Results-for-Genfit

[osaffer]

Jean-Christophe Marcoux, consultant at IMS Health

http://www.portail-ie.fr/article/1256/Are-European-biotechnology-companies-sufficiently-protected

[DewDiligence]

Who is JCM?

[osaffer]

Portal: But the French contender in NASH, Genfit, is the one that particularly gets your attention: why?

JMC: Genfit is indeed an interesting case. With only 80 employees, it already receives a high level of attention, and the first reason for it is the potential of its main molecule GFT505, now also known under the INN « Elafibranor ». The second reason is related to the fact that this molecule targets NASH (Non Alcoholic SteatoHepatitis), an untapped market estimated at more than $30 billion by analysts.

Genfit is the result of a virtuous ecosystem that finds its origin in the North of France, back in 1995 when M. Jean-François Mouney, then head of the economic and scientific parc Eurasanté provided guidance and leveraged both private and public strengths available at the time to build what is now a very large European pole of healthcare innovation. M. Mouney is now Chairman and CEO of Genfit.

If NASH is such an important disease area, it is because of its direct relation with the escalating obesity issue, which is obviously well known in the US, only emerging in EU according to WHO (predicting a real epidemic by 2030), and definitely also existing in Asia where « Fat China » is a worrying reality. Besides and equally importantly, patients are left with no cure today since no drug has been approved for NASH so far. Yet the medical need is certainly there, confirmed by the status of « breakthrough therapy » given by the FDA to a first contender in NASH. It’s also interesting to note that because NASH is a silent disease, diagnosis will be a major driver to realize the opportunity. In this respect the investment made by Genfit on biomarkers – as non-invasive diagnosis solution – goes in the right direction and might become a key differentiator.

Having said this, what makes GFT505/Elafibranor a serious contender in NASH is also the positive feedback received from the scientific and medical community, giving the molecule a strong flavor of potential blockbuster. First, its safety profile – a crucial element for the regulatory agencies, especially when it is about treating a chronic disease – is demonstrated by Phase 2b results. Then, its efficacy in the most severe patients (NAS=4, i.e. 85% of the NASH population): not only against placebo, but also when compared (with comparable groups of patients) to the other drug under development, obeticholic acid (OCA), despite a shorter clinical trial for GFT505. GFT505’s pluripotent profile also open doors for an interesting role in the management of cardio metabolic parameters.

But if Genfit is so emblematic in Europe today, it’s also because the gap between the company’s medical potential and its market capitalization as compared to its main competitor is difficult to justify. Genfit was « only » valued €1,6 billion a few weeks before the publication of its phase 2b results, while Intercept – the company developing OCA – was at the same time capitalized at about $7 billion. Biotechnology companies with molecule(s) in phase 3 can obviously not be evaluated against the financial benefit they generate, and are rather evaluated against their potential, which is related to (a) market size, (b) competitive environment, and (c) their relative strengths. While it is obvious that investment in early stage biotechnology is often risky, a reduction of the level of risk typically generates positive market reaction, which was far from the case for Genfit, considering the surprisingly negative – and also extreme – reaction of the market after the disclosure of the results. It therefore raises important questions, and several elements seem to be indicating that an orchestrated attack has somehow targeted Genfit for the likely benefit of players seeking an economic profit.

Portal: So you consider that Genfit’s high potential in NASH turned the French company into a primary target: how do you come to this conclusion?

JCM: First of all and to be clear, when it comes to economic war, European observers need to protect themselves from developing meaningless conspiracy theories. The best approach to avoid this risk is to observe facts with distance, without paranoia, but without innocence either, meaning a certain level of cynicism is recommended given the fact that we live in a world where « business is business ». In other words, some players are tough and unscrupulous, even though they act within legal boundaries and adopt a friendly stance.

With this in mind, let’s consider the context around Genfit before the disclosure of its phase 2b results:

Main competitor – The first contender in NASH is the US-based Intercept, developing the OCA drug. OCA seems efficient but at the same time raises serious questions on its safety profile. Such concerns expressed by the medical community potentially jeopardizes the launch of a phase 3 since both the FDA and the EMA are very strict on cardiovascular side effects. Moreover, the management of Intercept itself is in a difficult situation, since a class action has been triggered in the US, justified by what seems to be a truncated press release about the success of the FLINT study (phase 2b of OCA): indeed, the day after the announcement published by Intercept, the NIH had to publish a correction in the Wall Street Journal, providing additional details hidden the day before, and shedding a different light on the FLINT results.
Players – Beyond Intercept, other stakeholders are also involved, such as some major investors and some financial analysts, all sharing common interests.
Capitalization – Just before the announcement of the GOLDEN study (name of the Phase 2b for GFT505/Elafibranor in NASH) results, Intercept weighted $7 billion, against only €1,2 billion for Genfit end of March 2015. At that time, such a difference could be explained – but partially only – by the Nasdaq/Euronext differential, as well as by the relative advantage of Intercept from a calendar perspective (phase 2b already published, breakthrough therapy designation already granted by the FDA).
Then, a close look at the sequence of events after the publication of the GOLDEN results provides insights into what might have really happened:

March 27: Despite the good results disclosed, welcomed by Professor Dufour from the EASL governing board (« GFT505 (…) shows impressive results in phase 2b randomized controlled clinical trial »), Genfit stock loses 44% in one single day, based on analysts’ comments ignoring completely the overall content, really positive, of the press release, and focusing exclusively on what might be considered as a communication weakness. This oversight is surprising, especially coming from professionals able to understand the impact and the medical dimension of the GOLDEN results, and therefore the market potential behind.
April 24: At 13:30, i.e. the theoretical end time of the « Analysts and investors meeting » organized by Genfit aimed at providing additional elements of proof on GFT505 qualities (via three independent experts, and in the context of the international convention on liver disease in Vienna), the stock is once again seriously attacked while (a) it was gaining 6% in the morning after the press release disclosing – for legal reasons – the exact same content as the meeting, (b) the meeting itself is actually not yet over, and (c) no piece of news has leaked out of the room yet.
In both cases, volumes exchanged are very important, the timing is extremely precise, and negative resonance over social media is somewhat exaggerated and therefore suspicious.
Portal: Why such a destabilization attempt?

JCM: Looking at scientific elements available in March/April 2015, the situation of Intercept did not seem too bright, given the impending arrival of GFT505, potential threat to OCA due to its expected advantage in cardiometabolic protection. Intercept-involved stakeholders – investors and analysts alike – were therefore in a situation where weakening Genfit could have been seen as the only way forward. The rather challenging position of the American contender seems to be confirmed by the phase 3 design of OCA (REGENERATE study), disclosed on May 19:

This trial design is indeed aligned to what Genfit designed for its own phase 2b, i.e. « reversion of NASH without worsening of the fibrosis », while Intercept primary endpoint for its phase 2b was only « reduction of NAS score by a minimum of 2 points ».
Intercept has to include an arm at 10mg only, which seems to confirm that cardiovascular issues are a real concern, the idea probably being to reduce side effects, but the risk associated being of course a limited efficacy.
In addition, the clinical trial will have to be carried-out in an international multi-site setting, which is something new for Intercept (its phase 2b was only conducted in a limited number of sites in the US) while Genfit had already and proactively decided to remove ethnic/geographic/climatic bias from its phase 2b.
OCA will also have to be tested on an unexpected large number of patients, here again reinforcing the idea that cardiovascular side effects are a concern on the FDA side.
Last but not least, the phase 3 study is designed with 2 co-primary endpoints (the other being « reversion of fibrosis without worsening of NASH »), which obviously creates a higher risk of missing the target.
Portal: In this context, Genfit’s future is still bright, but what about other European biotechnology companies?

JCM: The Genfit example is indeed suggesting that other European biotechs could be similarly targeted, reinforcing the need to develop some kind of awareness around the risks they are exposed to. And here an interesting parallel can be made between what happened to Genfit at EASL congress, and what happened to another successful French biotech, Innate Pharma, at ASCO congress, where a negative note from an analyst – apparently unfounded – triggered a sharp decline of the stock value. Here again, nothing can be proven, but doubt is allowed.

It is actually not so complicated for a well-organized system to use stock market mechanisms to its own benefit. HFT (High Frequency Trading) is now common and its potential impact has been demonstrated in 2010 (flash crash). Pre-programmed robots can execute transactions on a predefined timing, and hedge-funds can use their power to act in a hidden way in order to orient stock. For instance, looking at Genfit closing price post-EASL shows rounded values three days in a row, which is probably not a total coincidence.

The role of financial analysts is another element that should not be underestimated, since they can really influence stock value, considering their – almost – direct impact on all non-specialist investors who tend to behave as simple followers.

Last but not least, from a cultural point of view, economic war seems to be more of a reality in the US than in Europe. This is at least what the German-supported US spying operation on European companies and officials by NSA is indicating. The European Commission’s investigations and conclusions about Google’s competitive behavior reinforce this sentiment. Hence, a crucial question comes to mind: is Europe ready to really protect its research programs? If the willingness to collaborate and develop collective intelligence – in order to get stronger – is clearly there (European Biotechnology Network), it is not entirely sure that the Old Continent is really ready to anticipate risks of sophisticated maneuvers. The risk for Europe is to lose some of its most successful research teams, and the risk for patients is to become indirect victims; the pace of scientific research being disturbed by external forces.

Portal: What are your conclusions and recommendations?

JCM: First I’d like to comment on what the economic war implies when it comes to healthcare. And here we should be clear. The economic war is certainly not an issue in itself, because it is the first and strongest driver for innovation. And for patients, innovation means better treatments, better health solutions, and ultimately better outcome. In that respect it does not really matter whether the winner is American, Chinese, or European. Having said this, whenever the economic war is based on disinformation or deception, there is a need to react, because the ultimate priority is to preserve patients’ interests. To come back to GFT505/Elafibranor, if the drug development is put at risk, or if the process takes longer because of unfair manipulations, the first victims will be patients: more liver transplants, more cardiovascular complications, more liver cancers. And the second victim will be the society as a whole, because it will have to bear all related extra costs.

It is therefore important that all stakeholders play their role, remain alert and vigilant. Institutions must defend citizens and protect all players that are helping these citizens to live a better life. Physicians should proactively ensure that information spread around new treatments is true, and well understood. Media should not ignore real topics, even if the temptation is sometimes strong to comment more futile pieces of news. And financial players should do their job in the interest of their clients, but also with some sort of consciousness about what their positions imply in terms of public health. Luckily, in the Genfit case, several elements indicate that patients’ interests will be preserved. First, Genfit board seems fully aware of what is potentially happening. Then, investors who do not speculate but invest based on fundamentals know what they do, and the most recent private investments in Genfit indicate an increased level of anglo-saxon presence. No doubt that big pharmas that might co-market GFT505/Elafibranor do also recognize the potential of the molecule. And in the end, the final word will anyway be for the FDA and the EMA, and they will undoubtedly play their role, as independent regulators seeking to improve patients’ lives above all. And by then, country-level institutions such as – in France – the Département de la sécurité économique driven by Eric Delbecque, will certainly have all possible threats clearly mapped on their radars.

The second element I would like to point out as a conclusion is the need for social media monitoring in healthcare. With the Genfit case we have briefly touched upon the value of listening to what is being said online from a strategic perspective. This activity is indeed essential to understand the digital landscape and influential networks: it helps to identify who says what, when, via what preferred channels, using what specific semantic, leveraging which viral element, etc. But to go beyond this dimension, and come back to the patient as a central point of attention, it is also important to understand that social media – as one element contributing to the massive shift towards digital/connected healthcare – represents a way to improve medical outcome. It is clear that patients and their families, KSAs (Key Social Advocates), doctors, KOLs (Key Opinion Leaders) and nurses did not wait to listen, produce and share content online. And as a privileged player here, I can tell that patients’ and other stakeholders’ voices are finally being heard. Active social listening has indeed almost become a « new normal » thanks to advanced solutions like Nexxus Social Media, considered by IDC as a key leading solution. The first reason is that it provides a valuable view on all unmet needs along the patient journey: symptoms, choice of a doctor or hospital, diagnosis, therapeutic choice, access to treatment, ease of administration, efficacy or side effects, etc. This helps to fuel thinking when it comes to designing innovative solutions, such as for instance new mobile apps for patients, new services for doctors or hospitals, or new devices for nurses. The second driver for adoption of this solution is related to the possibility to increase patient safety thanks to an in-depth monitoring of all possible adverse events declared online, performed through an optimum blend of technology and human intelligence. Experience and reality show that there are actually not so many adverse events – which actually does not really come as a surprise – but at least the solution provides a safety net for all players, who can be sure to follow specific regulations imposed by the FDA and the EMA.

About IMS Health

IMS Health is a leading global information and technology services company providing clients in the healthcare industry with comprehensive solutions to measure and improve their performance.End-to-end proprietary applications and configurable solutions connect 10+ petabytes of complex healthcare data through theIMS One™ cloud-based master data management platform, providing comprehensive insights into diseases, treatments, costs and outcomes.

The company’s 15,000 employees blend global consistency and local market knowledge across 100 countries to help clients run their operations more efficiently. Customers include pharmaceutical, consumer health and medical device manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community.

More information on www.imshealth.com

Catégorie : Santé et pharma
Dernière modification le 19/06/15

[DewDiligence]

ICPT hires SVP of medical affairs:

http://finance.yahoo.com/news/intercept-pharmaceuticals-appoints-juan-carlos-100000329.html

[osaffer]

http://seekingalpha.com/article/3235216-nash-as-the-next-hepatology-investment-opportunity-buy-durect-sell-intercept?%20amp;ifp=0

NASH As The Next Hepatology Investment Opportunity: Buy Durect, Sell Intercept
Jun. 4, 2015 5:12 AM ET | 14 comments | About: Durect Corporation (DRRX), ICPT
Disclosure: The author is long DRRX, AND IS SHORT ICPT. (More...)
Summary

Hepatitis C has proved to be an excellent investment opportunity; NASH appears equally promising.
DRRX has a licensed early-stage compound for NASH and acute kidney injury. Early animal data, while not necessarily a very good predictor, is favorable.
ICPT has a drug, OCA, for PBC and NASH. The PBC data is impressive, but NASH approval seems unlikely.
NASH (non-alcoholic steatohepatitis) represents a major unmet medical need in hepatology. It is a progressive form of fatty liver disease that is estimated to affect 19 million Americans. It involves fat accumulation in the liver, with additional histological findings of inflammation and ballooning. It can progress to fibrosis, cirrhosis and hepatocellular carcinoma. There are no approved FDA therapies for NASH, though many patients receive Vitamin E or pioglitazone based on results of the PIVENS trial last decade. NASH is expected to soon become the leading indication for liver transplant, ahead of Hepatitis C and alcoholic liver disease.

There are many drugs under development for NASH, and various parameters, including insulin resistance, inflammation and fibrosis, are being targeted. A beneficial therapeutic regimen may ultimately include a combination of agents. Regarding Intercept's (NASDAQ:ICPT) OCA, results from the phase 2b FLINT trial demonstrated an improvement in NAS (NAFLD Activity Score) of at least 2 points in 45% of patients versus 21% who received placebo, thereby achieving the primary histological endpoint. Statistical significance for the secondary endpoint of NASH resolution was not met. My concerns regarding this study relate to the concomitant use of Vitamin E or pioglitazone, the vanguard analysis design and to a lesser extent, the side effect profile of pruritis and higher serum lipids. As previously stated, I do expect Intercept to receive approval of OCA for the Primary Biliary Cirrhosis indication, which has fast track and orphan drug designations in the US. Positive Phase 3 results were presented last year. It should be noted that the OCA dose in PBC is less than half that used in NASH. Intercept's market capitalization currently approximates $6 billion, and the prevailing expectation is that it will be successful in its efforts in NASH. Insiders have been sellers of the stock.

Durect Corporation (NASDAQ:DRRX), by contrast, has a market capitalization of $335 million. It was originally a spinout from Alza, and has proprietary drug delivery platforms. It has been focusing on chronic pain, ADHD and schizophrenia. The analysts who follow DRRX have yet to assess the potential for its early-stage compound, DUR-928. This drug was licensed from VCU Medical Center, and has potential use in NASH and acute kidney injury, both of which represent significant opportunities. Phase 1 trial results in a small cohort of 30 subjects showed that the drug was well tolerated with no treatment-related adverse events. Additional phase 1 trials are planned, with the expectation of entering phase 2 in 2016. DUR-928 appears to have a beneficial effect on organ inflammation and fibrosis, as well as on glucose tolerance. In an oral formulation, it could have applicability in treating NASH, while as an injection, it could be used in acute organ injury. In animal models, which are not necessarily very relevant to human fibrotic disease, the drug has demonstrated reduced inflammation and fibrosis and a lowering of NAS, while improving insulin sensitivity. Insiders have been buyers of the stock.

I believe there is a stark contrast between my assessment of Intercept's prospect in NASH, Wall Street expectations, its market capitalization and recent insider activity and that of Durect Corporation. DRRX's effort in NASH is nascent, but safety and tolerability of the compound are favorable. Animal data is supportive, but phase 2 clinical trial results will be required for an understanding as to efficacy. In the meantime, the market capitalization is very low compared to most companies in the NASH space and insiders have been accumulating the stock. From a risk-reward standpoint, I find DRRX preferable. The upside potential is quite significant.

[Spike5]

Sorry that is not true ... U don't get put on the fast track by the FDA if your product is failing .

[osaffer]

ICPT is the failure, not GFT505.

Ok OCA goes to Phase 3, but it will have to reply on the end-points of results from GFT505

GFT505 molecule is really safety and efficient.

There is toxicity issue with OCA, there is also an increase of LDL. To decrease, ICPT has used Statine ... Statine is very bad for health following a recent research by danish laboratory.

Also, to success their PHASE2B, ICPT lies, there are some pursuits for that.

CEO of ICPT sold a lot of shares ...

Unfortunately, GFT505 results have been misundertood, or even manipulated by some analysts.

[oldsport]

what the hell happened ?

[DewDiligence]

More musings on NASH phase-3 risk: #msg-113821732.