Talk:Intercept Pharmaceuticals

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My name is Amanda Coren. I am with Twist Mktg, a communications agency working with Intercept Pharmaceuticals. On behalf of Intercept, I would like to open a conversation and suggest edits to this page that reflect Intercept’s recent milestones. I welcome feedback from any editor and thank you for your guidance. I am aware of Wikipedia's policies and guidelines, including those on WP:COI, WP:IRS, WP:V and WP:NPOV, and I will abide by them. My edit suggestions will be restricted to Talk pages, and I will not engage in directly editing any Intercept-related article. On any pages where I may suggest changes, I will be sure to disclose my relationship to Intercept in the interest of transparency. If you have any questions about my editing activities, please leave me a message on my User Talk page.

Revisions to Intercept Pharmaceuticals page

Please update the overview/key information box to include the following update to key people: Mark Pruzanski, M.D. (President and CEO) and Paolo Fundarò (Chairman of the Board of Directors)

Current:

Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC), non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary sclerosing cholangitis and also the intestinal disorder, bile acid diarrhea.

Revised:

Updated company description to include specific disease areas Intercept is researching
Added new section on Intercept’s global presence, including the company’s international headquarters in Europe and North America
Updated total number of employees

Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, such as primary biliary cholangitis (PBC, formerly primary biliary cirrhosis), non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia.

World presence

Intercept Pharmaceuticals has corporate operations in the United States, Europe, Canada and Australia.

North America

Intercept Pharmaceuticals’ corporate headquarters is located in New York, New York, and its research and development headquarters is located in San Diego, California.

Europe

The company’s international headquarters is located in London and its drug discovery headquarters is in Perugia, Italy.

As of December 31, 2015, the company had 405 employees worldwide.^[1]

Products

Current:

The company's lead product is Obeticholic acid, OCA, also known as 6-ethyl-chenodeoxycholic acid or INT-747. OCA is a potent first-in-class farnesoid X receptor (FXR) agonist. It is currently in phase III studies for primary biliary cirrhosis, and phase II studies for other diseases including NASH.

Other products in the development pipeline include INT-767, a dual FXR/TGR5 agonist, and INT-777, a TGR5 agonist.

Revised:

Added additional information on OCA, including its recent approval by the U.S. Food and Drug Administration to treat PBC, the status of its European Medicines Agency marketing authorization application, as well as additional clinical updates

The company's lead product is obeticholic acid, OCA, also known as 6-ethyl-chenodeoxycholic acid or INT-747 and branded as Ocaliva ® (obeticholic acid) in the United States. OCA is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. On May 27, 2016, the FDA granted accelerated approval for OCA (obeticholic acid) for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.^[2] Ocaliva is currently in a Phase 4 trial to establish whether it provides an improvement in survival, progression to cirrhosis, or other disease-related symptoms.

A marketing authorization application for Ocaliva for the treatment of PBC was accepted by the European Medicines Authority (EMA) in June 2015 and is currently under review. The brand name Ocaliva has been provisionally approved by the EMA.

Intercept Pharmaceuticals has a partnership with Sumitomo Dainippon Pharmaceuticals to out-licensed the rights of OCA in Japan, China and Korea.^[3]

OCA is also currently being studied in a Phase 3 study for NASH, and Phase 2 studies for other diseases including primary sclerosing cholangitis and biliary atresia.^[4]

Intercept’s development pipeline also includes INT-767, a dual FXR/TGR5 agonist for the treatment of organ damage due to fibrosis. INT-767 is currently in a Phase 1 trial with an anticipated completion date by the end of 2016.

History

Added new section discussing Intercept’s founding

Intercept was founded by CEO Mark Pruzanski, M.D., in 2002 in his apartment in New York City’s West Village.^[5]

Initial public offering and stock history

Current:

Intercept trades on the NASDAQ exchange under the ticker symbol ICPT. The initial public offering of the stock on October 16, 2012 was at $15. A follow-on public offering at $33 took place on June 24, 2013.

On January 9, 2014, the stock skyrocketed from $72.39 to $275.49, or about 280%, after a planned interim analysis by the independent data safety monitoring board showed that Obeticholic acid met the main goal (improvement of liver histology) at the mid-stage in the FLINT trial in NASH, sponsored by NIDDK. The stock continued to climb to $497 over the next few days before falling back to around $317 on March 29, 2014, giving a market capitalization of around $6.2 billion.

In March 2014, the company released the results of the POISE study of Obeticholic acid in PBC, which showed the drug met the trial's primary endpoint of a reduction in serum alkaline phosphatase, a biomarker for the disease. These results were presented at an international liver meeting in April 2014.

As of 31 December 2014, the company had 136 employees.

Revised:

Removed outdated company information as well as information that does not pertain to stock history

Intercept trades on the NASDAQ exchange under the ticker symbol ICPT. The initial public offering of the stock on October 16, 2012 was at $15.^[6] A follow-on public offering at $33 took place on June 24, 2013.

On January 9, 2014, the stock skyrocketed from $72.39 to $275.49, or about 280%, after a planned interim analysis by the independent data safety monitoring board showed that obeticholic acid met the main goal (improvement of liver histology) at the mid-stage in the FLINT trial in NASH, sponsored by NIDDK.^[7]^[8] The stock continued to climb to $497 over the next few days before falling back to around $317 on March 29, 2014, giving a market capitalization of around $6.2 billion.

References

^ Intercept Pharmaceuticals. "Form 10-k: Annual report 2015". Retrieved July 19, 2016.
^ FDA (May 31, 2016). "FDA Approves Ocaliva For Rare, Chronic Liver Disease". Retrieved July 19, 2016.
^ Sumitomo Dainippon Pharmaceuticals Co., Ltd (March 30, 2011). "Dainippon Sumitomo Pharma And Intercept Pharmaceuticals Announce Agreement To Develop And Commercialize Obeticholic Acid (INT-747) For Chronic Liver Disease". Retrieved July 19, 2016.
^ ClinicalTrials.gov. "Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)". Retrieved July 19, 2016.
^ The Wall Street Journal (January 14, 2014). "Hot New Biotech Knows Roller-Coaster Feeling". Retrieved July 19, 2016.
^ "Intercept Pharmaceuticals: Strong Biopharmaceutical IPO". Seeking Alpha. October 14, 2012. Retrieved 2014-03-21.
^ "The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)".
^ Intercept Pharmaceuticals. "Press release: Intercept Announces NASH Primary Endpoint Met: FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology". Retrieved January 9, 2014.

Acoren (talk) 17:56, 11 October 2016 (UTC)[reply]

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Revisions to Summary Box - Edit Suggestions

Please update the overview/key information box to include the following updates: Current: Key people: Mark Pruzanski (President and CEO) Paolo Fundarò (Chairman of the Board of Directors)

Revenue

$250.2 Million(2019)

Revise: Key People: Jerome Durso (President and CEO) Mark Pruzanski (Founder, Strategic Advisor & Board Member) Paolo Fundarò (Chairman of the Board of Directors)

Revenue $100.4 million (Q2/2022)https://ir.interceptpharma.com/news-releases/news-release-details/intercept-pharmaceuticals-reports-second-quarter-2022-financial InterceptCA (talk) 15:18, 8 August 2022 (UTC)[reply]

[1] Intercept Pharmaceuticals. "Form 10-k: Annual report 2015". Retrieved July 19, 2016.

[2] FDA (May 31, 2016). "FDA Approves Ocaliva For Rare, Chronic Liver Disease". Retrieved July 19, 2016.

[3] Sumitomo Dainippon Pharmaceuticals Co., Ltd (March 30, 2011). "Dainippon Sumitomo Pharma And Intercept Pharmaceuticals Announce Agreement To Develop And Commercialize Obeticholic Acid (INT-747) For Chronic Liver Disease". Retrieved July 19, 2016.

[4] ClinicalTrials.gov. "Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)". Retrieved July 19, 2016.

[5] The Wall Street Journal (January 14, 2014). "Hot New Biotech Knows Roller-Coaster Feeling". Retrieved July 19, 2016.

[6] "Intercept Pharmaceuticals: Strong Biopharmaceutical IPO". Seeking Alpha. October 14, 2012. Retrieved 2014-03-21.

[7] "The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)".

[8] Intercept Pharmaceuticals. "Press release: Intercept Announces NASH Primary Endpoint Met: FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology". Retrieved January 9, 2014.

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