Intercept Pharmaceuticals Inc. became the third biotech in three weeks to file an S-1 registration statement with the SEC for a proposed initial public offering (IPO), following Regulus Therapeutics Inc. and OvaScience Inc. into the queue. (See BioWorld Today, Aug. 21, 2012.)

New York-based Intercept did not disclose the number of shares or price range for the offering but said it would seek to raise up to $75 million.

Intercept, which said shares would trade on Nasdaq under the symbol "ICPT," is seeking to qualify as an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012.

The S-1's timing was notable for another reason. Last month, Intercept picked up $30 million in a Series C preferred stock financing led by OrbiMed Advisors LLC, with participation from existing majority investor Genextra SpA.

Intercept isn't the first biotech this year to pursue an IPO on the heels of a private raise. In March, Tesaro Inc. filed an S-1 seeking to raise up to $86.3 million to advance rolapitant, its selective neurokinin-1 (NK1) receptor antagonist with an extended plasma half-life.

That filing indicated Tesaro had issued 26.9 million shares of Series B preferred stock the previous week, for net proceeds of about $58.3 million, with the shares slated to convert into common stock immediately prior to the IPO's closing. (See BioWorld Today, March 27, 2012.)

The Tesaro IPO priced in June, within the expected range, with the company selling 6 million shares at $13.50 apiece. (See BioWorld Today, June 29, 2012.)

Intercept, which is seeking to develop therapies for orphan and more common liver diseases using bile acid chemistry, likely seeks the same trajectory, noting that existing stockholders and affiliates indicated interest in participating in the IPO.

The company's lead product candidate, obeticholic acid (OCA), is a bile acid analogue and first-in-class agonist of the farnesoid X receptor (FXR). Initially, the compound is in development in second-line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol – the only approved therapy in the indication.

A chronic autoimmune liver disease, PBC may progress to cirrhosis and liver failure and currently is the fifth leading indication for liver transplant in the U.S. OCA has orphan drug designation in both the U.S. and Europe in PBC.

The company completed two randomized, placebo-controlled Phase II trials of OCA in PBC and is enrolling its Phase III POISE trial. Eligible PBC patients on a stable therapeutic dose of ursodiol will continue that treatment and be randomized into one of three trial arms of 60 patients each, adding either 10 mg of OCA, 5 mg of OCA increasing over the course of the trial to 10 mg of OCA or placebo.

The global, multicenter, double-blind phase of the trial is designed to last 12 months. Intercept expects enrollment to be completed in the first half of 2013, with results from the trial expected to report in the second half of 2014.

Provided POISE succeeds, the company plans to submit a new drug application (NDA) for OCA in PBC to the FDA, requesting accelerated approval, and a marketing authorization application to the European Medicines Agency.

In the S-1, Intercept acknowledged the likelihood the FDA will require a Phase III outcomes trial to confirm the clinical benefit predicted by the POISE study's biochemical therapeutic response. The company said it is already discussing trial design with the FDA and expects to have the trial "substantially under way at the time of the NDA submission" for completion after accelerated approval.

Intercept owns global rights to OCA except in Japan and China, where it out-licensed the compound to Dainippon Sumitomo Pharma Co. Ltd. (DSP) in a 2011 strategic partnership potentially worth $315 million in up-front and milestone payments, plus tiered double-digit royalties. DSP also holds an option to exclusively license OCA in certain other Asian countries. (See BioWorld Today, March 31, 2011.)

Beyond OCA, which also is under investigation in portal hypertension, nonalcoholic steatohepatitis and bile acid diarrhea, Intercept is developing a TGR5 agonist, INT-777, in diabetes and a dual FXR/TGR5 agonist, INT-767, in fibrosis.

Last year, the company inked a $163 million collaboration with Les Laboratoires Servier covering the discovery and clinical development stages of TGR5 agonists in Type II diabetes and other metabolic indications. Under the agreement, which included up-front, research support and milestone payments as well as royalties, Intercept and Servier are jointly supporting the discovery stage. Neuilly, France-based Servier will be responsible for costs associated with the global development, regulatory approval and commercialization of any compound selected as a lead candidate. (See BioWorld Today, Aug. 10, 2011.)

Intercept retained rights in Japan and the U.S., with Servier obtaining rights in the rest of the world.

In the S-1, the company reported 19.2 million shares of common stock outstanding on June 30. Intercept reported $39.7 million in cash and equivalents, on a pro forma basis, as of June 30.

BofA Merrill Lynch is acting as sole book-running manager for the IPO. BMO Capital Markets is acting as lead manager, with Needham & Co. LLC, Wedbush PacGrow Life Sciences and ThinkEquity LLC acting as co-managers.