Follow the Money: Intercept Pharmaceuticals, Inc.
Follow the Money highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.
Intercept Pharmaceuticals, Inc. is a U.S. public pharmaceutical company that develops small molecule drugs for the treatment of chronic liver and metabolic diseases. As reported in the April 9, 2015 issue of the PharmSource Lead Sheet, Intercept raised $366.8 million in the completion of a secondary public offering.
- Intercept was incorporated in Delaware on September 4, 2002.
- Corporate Headquarters: New York, NY – approximately 20,626 square feet of office space.
- Facility: San Diego, CA – approximately 47,000 square feet of laboratory space.
- As of December 31, 2014, Intercept had 136 employees, of whom 92 were engaged in drug development operations.
- Intercept plans to use the proceeds to support:
- Expansion of clinical, regulatory, medical affairs, and commercial infrastructure in the US and Europe
- Clinical development program for obeticholic acid (OCA)
- Expansion of OCA manufacturing activities
- Advancement of INT-767 and other preclinical programs
- Preparation for a potential 2016 launch of OCA in primary biliary cirrhosis in the US and certain European countries.
- The company contracts with Contract Research Organizations to conduct clinical trials.
- Intercept does not own or operate manufacturing facilities and has no plans to develop them. The company relies on contract manufacturers for all required raw materials, API, and finished product for clinical trials and preclinical studies. However, Intercept does not have long-term or commercial agreements with any of its third-party providers.
- The company currently intends to qualify a back-up API manufacturer.
- Intercept has no sales, marketing or distribution experience.
- In March 2011, Intercept and Sumitomo Dainippon entered into an agreement for the development and commercialization of Intercept’s obeticholic acid (OCA) in Japan and China as a treatment for chronic liver diseases, with an initial focus on primary biliary cirrhosis and nonalcoholic steatohepatitis. Intercept received a $15 million initial payment and is eligible for $300 million in milestones and royalties. Dainippon will fund development and commercialization in its territory. Dainippon also has the exclusive option to add other Asian countries and to pursue additional indications.
- In August 2011, Intercept and Servier entered into a worldwide agreement, excluding Japan and the US, for the discovery and development of novel TGR5 agonists for the treatment of type 2 diabetes and other metabolic indications. The collaboration uses Intercept’s drug discovery platform and Servier is responsible for all costs associated with the global development, regulatory approval and commercialization of selected compounds. Intercept retains all rights in the US and Japan.
|Product Candidate||Indication||Dosage Form||Status||Next Anticipated Step|
|Type 2 Diabetes||Oral||Preclinical||TBA|
|Fibrosis||Oral||Preclinical||Plans to initiate Phase I trial by end of 2015.|
|OCA (FXR Agonist)||Biliary Atresia||Oral||Preclinical||Plans to initiate Phase II trials in H2 2015.|
|OCA (FXR Agonist)||Primary Sclerosing Cholangitis (PSC)||Capsule||Phase II||TBA|
|OCA (FXR Agonist)||Nonalcoholic Steatohepatitis (NASH)||Capsule||Phase II||Plans to initiate Phase III trials in H1 2015.|
|OCA (FXR Agonist)||Primary Biliary Cirrhosis (PBC)||Capsule||NDA Filed||TBA|
|(In $ thousands)||2014||2013|
|General & Administrative Expenditures||34,601||13,132|
|Total Operating Expenses||114,912||41,073|
|Intercept Pharmaceuticals, Inc.||Key Officers|
|450 W 15th Street, Suite 505||Mark Pruzanski, MD, President & CEO|
|New York, NY 10011, USA||David A. Shapiro, MD, CMO & EVP, Development|
|Phone: 646-747-1000||Luciano Adorini, MD, CSO|
|Fax: 646-747-1001||Barbara Duncan, CFO & Secretary|
|Web: www.interceptpharma.com||Pia Lindström PhD, VP, Regulatory Affairs & Quality Assurance|