INTERCEPT (ICPT) mit Potenzial USD 64.46 (27.9.19)

eröffnet am 28.09.19 23:46:35 von
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28.09.19 23:46:35
Intercept hat den Zulassungsantrag (NDA) von Ocaliva zur Behandlung von durch NASH verursachte Fibrose, wie angekündigt im 3q19, bei der FDA eingereicht und kündigt bereits an, im 4q19 den Zulassungsantrag auch bei der EMA einzureichen. Gleichzeitig wurde bei der FDA eine beschleunigte Bearbeitung des Zulassungsantrages (Priority Review) beantragt. Falls dies genehmigt wird, und davon ist auszugehen, könnte eine Zulassungsentscheidung Ende März 2020 realistisch sein.
Bin mit 500 Stück am Freitag eingestiegen.

Sep 27, 2019
Intercept Submits New Drug Application to the U.S. FDA for Obeticholic Acid in Patients with Fibrosis Due to NASH
PDF Version
NDA supported by positive interim analysis results from REGENERATE Phase 3 study demonstrating OCA’s improvement of liver fibrosis without worsening of NASH

NEW YORK, Sept. 27, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Adminstration (FDA) for obeticholic acid (OCA) for the treatment of patients with fibrosis due to nonalcoholic steatohepatitis (NASH).
OCA is the only investigational therapy to meet the primary endpoint of a Phase 3 study in patients with NASH and is the only such therapy that the FDA has designated a Breakthrough Therapy for NASH with fibrosis. As such, Intercept has requested a Priority Review for the NDA, which, if granted, would result in an anticipated six-month review period.
The submission is based on positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH. In the study, OCA 25 mg achieved its primary endpoint by demonstrating robust improvement in liver fibrosis (by ≥1 stage) without worsening of NASH at 18 months (p=0.0002 vs placebo).
“Our submission of the first NDA for the treatment of fibrosis due to NASH is a very important milestone for the field and the culmination of more than a decade of hard work,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “I am grateful to the thousands of NASH patients participating in our clinical studies, the investigators and study personnel at our study sites around the globe, and the entire Intercept team for bringing us to this point. We look forward to continuing to work with the FDA through the NDA review period and believe that, if approved, OCA has the potential to become an essential treatment for people living with advanced fibrosis due to NASH.”
Intercept also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the fourth quarter of this year.


ir.interceptpharma.com/news-releases/news-release-details/in…
Intercept Pharmaceuticals | 64,12 $
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01.10.19 09:00:15
Antwort auf Beitrag Nr.: 61.591.119 von Cyberhexe am 28.09.19 23:46:35aus dem letzten Quartalsbericht (2q19 auf Ende Juni) über die Vereinbarung mit Sumitomo zur Vermarktung von Ocaliva in Asien:

- Sumitomo Dainippon hat die Rechte zur Vermarktung in Japan und Korea zurückgegeben
- falls bestimmte Meilensteine in der Klinik in China bis zum 31.12.2020 nicht erreicht werden, kann auch dieser Vertrag gekündigt werden
- ursprünglich vereinbart wurden gestaffelte Lizenzzahlungen bis zu "mid-twenties" % vom Nettoumsatz





4. Significant Agreements
Sumitomo Dainippon Pharma Co., Ltd

in percentage terms based on net sales of OCA products in China (excluding Taiwan). Sumitomo Dainippon is responsible for the costs of developing and commercializing OCA in its territory.
The Company has concluded that Sumitomo Dainippon does not represent a customer of the Company, and therefore the Sumitomo Agreement is outside of the scope of ASC 606. The Company has accounted, and continues to account, for the Sumitomo Agreement under the legacy accounting guidance. The Company’s substantive performance obligations under this agreement include an exclusive license to its technology, technical and scientific support to the development plan and
participation on a joint steering committee. The Company determined that these performance obligations represent a single unit of accounting, since, initially, the license does not have stand-alone value to Sumitomo Dainippon without the Company’s technical expertise and steering committee participation during the development of OCA. The development period is currently estimated as continuing through June 2020 and, as such, the $15.0 million upfront payment is being
recognized ratably over this period. The Company recognized licensing revenue of $0.4 million and $0.4 million for the three months ended June 30, 2019 and 2018, respectively, and $0.8 million and $1.2 million for the six months ended June 30, 2019 and 2018, respectively, under the Sumitomo Agreement. Included in licensing revenue for the six months ended June 30, 2018 is $0.4 million related to the accelerated recognition, as a result of the Sumitomo Amendment, of the
remaining portion of deferred revenue associated with the $1.0 million upfront payment that the Company received under the Original Sumitomo Agreement in connection with Sumitomo Dainippon’s exercise of the Country Option with respect to Korea.
The Company recognizes milestone payments when the associated milestones are achieved. As of June 30, 2019, and December 31, 2018, the Company had recorded deferred revenues of $1.6 million and $2.4 million, respectively, under this agreement.
...
The Company may be eligible to receive additional milestone payments under
the Sumitomo Agreement in an aggregate amount of up to approximately $23.0 million based on the occurrence of certain clinical trial and regulatory-related events and tiered royalty payments up to the mid-twenties in percentage terms based on net sales of OCA products in China (excluding Taiwan). Sumitomo Dainippon is responsible for the costs of developing and commercializing OCA in its territory.


http://ir.interceptpharma.com/static-files/ff11140a-262c-4bf…
Intercept Pharmaceuticals | 60,84 €
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21.10.19 08:53:05
Antwort auf Beitrag Nr.: 61.603.048 von Cyberhexe am 01.10.19 09:00:15innerhalb der nächsten 5 Wochen hat die FDA darüber zu entscheiden, ob der von Intercept eingereichte Zulassungsantrag von Ocaliva zur Behandlung einer durch NASH verursachten Fibrose formal angenommen wird - formal heisst, dass der Zulassungsantrag auf Vollständigkeit geprüft wird. Sollte der Antrag angenommen werden, dürfte der Kurs auf über $70 anziehen.
Intercept Pharmaceuticals | 58,30 €
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21.10.19 14:26:09
Antwort auf Beitrag Nr.: 61.732.429 von Cyberhexe am 21.10.19 08:53:05
Zitat von Cyberhexe: innerhalb der nächsten 5 Wochen hat die FDA darüber zu entscheiden, ob der von Intercept eingereichte Zulassungsantrag von Ocaliva zur Behandlung einer durch NASH verursachten Fibrose formal angenommen wird - formal heisst, dass der Zulassungsantrag auf Vollständigkeit geprüft wird. Sollte der Antrag angenommen werden, dürfte der Kurs auf über $70 anziehen.


Falls kein AC einberufen und Priority Review zugestanden wird, dürfte der Kurs relativ scghnell $80 überschreiten.

Time will tell!
Intercept Pharmaceuticals | 58,30 €
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22.10.19 21:07:36
Antwort auf Beitrag Nr.: 61.734.982 von Cyberhexe am 21.10.19 14:26:09interessante Aussagen in nachfolgendem Artikel veröffentlicht am 8.9.19 im Journal "Hepatology Research"

- das NASH-Marktvolumen in den 7 wichtigsten Märkten wird in 2026 auf über 25 Milliarden USD geschätzt

- ein NASH-Medi wird frühestens 2021 am Markt sein

--> ich glaube allerdings, dass Ocaliva noch in 2020 von der FDA die Marktzulassung erhalten wird. Bis zum 26.11. hat die FDA formal über die Antragsannahme zu entscheiden und wird dann sehr wahrscheinlich bekanntgeben, ob Priority Review gewährt wird....womit eigentlich zu rechnen ist. PDUFA könnte dann Ende 1q2020 sein. Das ist der frühestmögliche Zeitpunkt für die Zulassungsentscheidung. Falls positiv - ich rechne damit-, dürfte der Kurs dreistellig sein!





Phase 3 drug pipelines in the treatment of NASH
Yoshio Sumida Takeshi Okanoue Atsushi Nakajima Japan Study Group of NAFLD (JSG‐NAFLD)
First published: 08 September 2019

Abstract
Nonalcoholic steatohepatitis (NASH) which is a more severe form of nonalcoholic fatty liver disease (NAFLD) can at least partly lead to cirrhosis, hepatocellular carcinoma (HCC), and hepatic failure. Liver transplantation is the only option for NASH cirrhosis at this time. By 2020, NASH is projected to overtake hepatitis C as the leading cause of liver transplants in the U.S. There are still no approved drugs for treating NASH. Although there are about 196 agents of investigational NASH therapies in various stages of development, we here mainly review phase 3 drug candidates in the pipeline for NASH. The NASH space across the seven major markets of the U.S., France, Germany, Italy, Spain, the UK, and Japan, is set to rise from $618 million in 2016 to around $25.3 billion by 2026. However, the fact that the race to develop an effective drug against NASH has reached the home stretch, with five drug candidates (obeticholic acid, elafibranor, selonsertib, cenicriviroc, and resmetirom) in phase 3 stage of the trial, is welcome news for patients. The very earliest a NASH drug could hit the market is 2021, assuming all goes well as planned.





https://onlinelibrary.wiley.com/doi/abs/10.1111/hepr.13425" target="_blank" rel="nofollow ugc noopener">https://onlinelibrary.wiley.com/doi/abs/10.1111/hepr.13425
Intercept Pharmaceuticals | 68,40 $
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26.10.19 09:24:27
Antwort auf Beitrag Nr.: 61.732.429 von Cyberhexe am 21.10.19 08:53:05
Zitat von Cyberhexe: innerhalb der nächsten 5 Wochen hat die FDA darüber zu entscheiden, ob der von Intercept eingereichte Zulassungsantrag von Ocaliva zur Behandlung einer durch NASH verursachten Fibrose formal angenommen wird - formal heisst, dass der Zulassungsantrag auf Vollständigkeit geprüft wird. Sollte der Antrag angenommen werden, dürfte der Kurs auf über $70 anziehen.


...der "Zug" scheint langsam Fahrt aufzunehmen. Gestern +$5.10 auf $73.49.
Intercept Pharmaceuticals | 66,40 €
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05.11.19 13:19:49
Antwort auf Beitrag Nr.: 61.770.947 von Cyberhexe am 26.10.19 09:24:27Intercept Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update


Worldwide Ocaliva net sales of $61.5 million in the third quarter of 2019 representing 32% growth versus the prior year quarter; increasing full year 2019 worldwide Ocaliva net sales guidance range to between $245 million and $250 million

U.S. NDA for NASH submitted; EU MAA submission for NASH planned for fourth quarter of 2019

New NASH and PBC clinical data to be presented at The Liver Meeting® 2019

Conference call scheduled for 8:30 a.m. ET today

http://ir.interceptpharma.com/news-releases/news-release-det…
Intercept Pharmaceuticals | 68,42 €
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05.11.19 14:31:36
Antwort auf Beitrag Nr.: 61.840.350 von Cyberhexe am 05.11.19 13:19:49nicht gerade beeindruckendes Quartal, Ocaliva net sales im Vergleich zu Q2 rückläufig (65.9 -> 61.5), Geld ist noch genug vorhanden, alles hängt von der Zulassung für NASH nächstes Jahr ab
Intercept Pharmaceuticals | 68,00 €
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05.11.19 20:29:31
Antwort auf Beitrag Nr.: 61.840.920 von paul81 am 05.11.19 14:31:36Intercept Pharmaceuticals (NASDAQ:ICPT)‘s stock had its “buy” rating reiterated by analysts at Needham & Company LLC in a research report issued to clients and investors on Tuesday, AnalystRatings.com reports. They presently have a $150.00 price target on the biopharmaceutical company’s stock.


...Needham hat das Kursziel von $150 bestätigt - nit too bad!
Intercept Pharmaceuticals | 75,45 $
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05.11.19 20:42:29
Antwort auf Beitrag Nr.: 61.845.066 von Cyberhexe am 05.11.19 20:29:31...von der Quartalspressekonferenz von heute:

- interessanter Hinweis auf das Treffen der "American Association for the study of Liver Diseases" --> AASLD, welches vom 8. bis 12. November in Boston, Massachusetts, stattfinden wird. Mehr als 20 "Abstracts" und "late breaking abstracts" werden angekündigt. Vora allem der Hinweis, dass "...demonstrating OCA's durable therapeutic benefit with no new long-term safety findings in PBC patients on treatment for up to six years"
kein neues Signal bei der Langzeittherapie (5 Jahre !) festgestellt wurde, erhöht die Zulassungswahrscheinlichkeit auch in der Indikation "NASH mit Fibrose".

In addition to the execution of our regulatory filings, we've continued to be laser focused on ensuring commercial readiness for the first-ever NASH launch. With more than 15 years of experience focused on the development of novel therapies to treat progressive non-viral liver diseases, Intercept remains the only company to have demonstrated a therapeutic anti-fibrotic benefit in large placebo-controlled Phase II and III trials with our first-in-class FXR agonist OCA that we believe to be crucial for the effective treatment of patients with advanced fibrosis due to NASH.
As the leader in this space, we've proven time and again, there simply are no shortcuts. Developing effective new treatments for these indications is a marathon, not a sprint, and we remain well positioned for continued success with the anticipated first-approved NASH therapy on the horizon. We are in the fortunate position to be building on our established strong standing within the liver community globally. Based on the foundation we've built and ongoing commercial success of our PBC business worldwide, we have great confidence in our ability to execute a successful first-to-market launch of OCA in NASH, which provided FDA grants us priority review and approval, could be as early as the spring of 2020.
I mentioned PBC and I'm pleased to point out the continued strong momentum in our business globally. We've continued to see steady demand growth versus the prior year quarter, based on solid execution of our commercial organization worldwide. Given our performance to date, we've now increased our 2019 full year net sales guidance for Ocaliva to between $245 million and $250 million.
We believe our established medical and commercial infrastructure supporting the PBC business uniquely positions us for success in NASH. We've developed strong relationships with hepatologists and gastroenterologists, the specialists treating patients with advanced fibrosis due to NASH, many of whom have already gained valuable experience prescribing Ocaliva to PBC patients. As we've previously stated, we are flexing up our existing infrastructure and capabilities, while building on our relationships within the community in preparation for our NASH launch.
Following its anticipated approval, OCA is positioned to become the foundational therapy in patients with advanced fibrosis due to NASH. We continue to have productive interactions with physicians, payers and patient groups, which Jerry will discuss in more detail shortly. These stakeholders all recognize the critical importance of a therapy with a robust anti-fibrotic benefit, underscoring what we believe to be OCA's key advantage.


I now want to pivot and spend some time discussing the upcoming Annual Meeting of the American Association for the study of liver diseases, the AASLD Liver meeting, where we will have a significant presence and more than 20 abstracts being presented in the general and late-breaker sessions. Our team is dedicated to our customers in the hepatology community and we're excited about the posters and presentations that will be showcased at the liver meeting.
Some highlights, on the PBC side, we're presenting the final results from our Phase III poised 5-year open-label phase, demonstrating OCA's durable therapeutic benefit with no new long-term safety findings in PBC patients on treatment for up to six years. On the NASH side, we'll have an oral presentation of the REGENERATE interim analysis results in the expanded intent-to-treat population, which reinforces the consistent benefit that OCA provides across the broader patient population. There are also two important patient-reported outcome or PRO abstracts from REGENERATE, including one demonstrating that patient-reported quality of life scores are substantially below population norms, indicating that NASH with established fibrosis is not an asymptomatic disease. And that effective anti-fibrotic treatment can improve PRO scores.
Intercept Pharmaceuticals | 75,44 $


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