Intercept Pharmaceuticals

In today's world, Intercept Pharmaceuticals is an issue that is becoming increasingly relevant in society. Over time, Intercept Pharmaceuticals has become a fundamental aspect in people's daily lives, influencing their decisions and actions. Since Intercept Pharmaceuticals it has evolved and adapted to new trends and technologies, becoming a topic of common interest for a wide variety of people. In this article, we will thoroughly explore the impact of Intercept Pharmaceuticals on today's society and how it has gained importance over the years.

40°40′43″N 78°14′35″W / 40.678631°N 78.243038°W / 40.678631; -78.243038

Intercept Pharmaceuticals, Inc.
Company typeSubsidiary
Nasdaq: ICPT (2012-23)
IndustryBiotechnology
Founded2002 (2002)
FateAcquired by Alfasigma
Headquarters
Morristown, New Jersey
,
United States[1]
Key people
Jerome Durso (president and CEO)
Paolo Fundarò
(chairman of the Board of Directors)
RevenueIncrease $250.2 Million (2019)[2]
Websitewww.interceptpharma.com

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) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary sclerosing cholangitis and also the intestinal disorder, bile acid diarrhea.

Products

The company's lead product is Ocaliva (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. In 2016, the U.S. Food and Drug Administration (FDA) approved Ocaliva for use in primary biliary cholangitis.[3]

In June 2024, the European Medicines Agency (EMA) recommended revoking the conditional marketing authorization for Ocaliva. The decision followed a review by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the benefits of Ocaliva no longer outweigh its risks. The European Commission officially revoked Ocaliva's marketing authorization on August 30, 2024.[4]

In November 2024, the U.S. Food and Drug Administration (FDA) declined to grant full approval for Ocaliva as a treatment for primary biliary cholangitis (PBC), a rare autoimmune liver disease. This decision followed a September 2024 advisory committee meeting where 13 out of 14 panel members concluded that Intercept's data did not adequately demonstrate Ocaliva's clinical benefit. Consequently, the FDA issued a complete response letter, indicating that the supplemental new drug application could not be approved in its current form. Despite this setback, Ocaliva remains available in the U.S. under the accelerated approval granted in 2016, which requires ongoing post-marketing studies to confirm its clinical benefits. The FDA is continuing to review data from these studies, including trial 747-302 (NCT02308111), and has noted concerns about serious liver injury in some patients without severe scarring.[5]

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

On June 29, 2020, the company released a statement announcing that FDA had rejected its lead product obeticholic acid, OCA, because FDA officials had determined that "the predicted benefit of the drug does not sufficiently outweigh the predicted risks".[6]

Initial public offering and stock history

Intercept traded on the NASDAQ exchange under the ticker symbol ICPT. The initial public offering of the stock on October 16, 2012 was at $15.[7] 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.[8][9] 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.[10] These results were presented at an international liver meeting in April 2014.[11]

As of 31 December 2014, the company has 136 employees.[12]

In 2023, Intercept Pharmaceuticals was acquired by Italian Alfasigma S.p.A for $19.00 per share in cash (approximately $800 million).[13][14][15]

References

  1. ^ "Contact Us". Intercept Pharmaceuticals. Retrieved 13 April 2022.
  2. ^ "Intercept Pharmaceuticals Revenue 2011-2021 | ICPT".
  3. ^ Research, Center for Drug Evaluation and (2020-07-09). "Drug Trials Snapshots: OCALIVA". FDA.
  4. ^ "EMA recommends revoking conditional marketing authorisation for Ocaliva | European Medicines Agency (EMA)". www.ema.europa.eu. 2024-06-28. Retrieved 2025-02-06.
  5. ^ Barrie, Robert (2024-11-13). "Intercept loses Ocaliva FDA full approval bid in rare liver disease". Pharmaceutical Technology. Retrieved 2025-02-06.
  6. ^ "FDA rejects Intercept Pharma's drug for fatty liver disease". 29 June 2020.
  7. ^ "Intercept Pharmaceuticals: Strong Biopharmaceutical IPO". Seeking Alpha. October 14, 2012. Retrieved 2014-03-21.
  8. ^ "The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)". Archived from the original on 2014-01-10.
  9. ^ Intercept Pharma. "Press release: Intercept Announces NASH Primary Endpoint Met: FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology". Archived from the original on November 29, 2014. Retrieved January 9, 2014.
  10. ^ Intercept Pharma. "Press release: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results". Archived from the original on March 26, 2014. Retrieved March 27, 2014.
  11. ^ "Intercept's liver disease drug proves highly effective in study". Reuters. April 12, 2014. Retrieved April 14, 2014.
  12. ^ Intercept Pharmaceuticals. "Form 10-k: Annual report 2014". Retrieved October 2, 2015.
  13. ^ "Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases". Yahoo Finance. 2023-09-26. Retrieved 2023-09-26.
  14. ^ "Madrigal Pursues $500M Public Offering with NASH Market Up for Grabs". On Tuesday, still reeling from the rejection and left with no other advanced assets, Intercept agreed to be acquired by Italian pharma Alfasigma S.p.A for $800 million.
  15. ^ "Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc". Yahoo! Finance. Retrieved 2024-01-07.