AGCM

DRUGS: ANTITRUST LAUNCHES AN INVESTIGATION TO CHECK A POSSIBLE ABUSE OF DOMINANT POSITION BY THE COMPANY INDUSTRIA CHIMICA EMILIANA AND ITS SUBSIDIARY PRODOTTI CHIMICI E ALIMENTARI, ENGAGED IN THE PRODUCTION OF CHOLIC ACID AND OF AN ACTIVE INGREDIENT INTENDED FOR PHARMACEUTICAL PURPOSES

Cholic acid is a basic element for the production of ursodeoxycholic acid, an active ingredient used in drugs (including generic drugs) prescribed for the treatment of severe and widespread liver diseases. Possible negative effects on pharmaceutical companies and final consumers of drugs. The measure was notified today in the course of inspections that were carried out in collaboration with the Antitrust Group of the Special Market Protection Market Unit of the Guardia di Finanza (Italian Tax Police)

At its meeting held on 10^th December 2013 the Autorità Garante della Concorrenza e del Mercato decided to launch an investigation into whether the company Industria Chimica Emiliana S.p.A. (ICE), also through its subsidiary Prodotti Chimici e Alimentari S.p.A. (PCA), had abused of its dominant position in the production and sale of cholic acid, a semi-finished product of bovine bile extract that is required for the production of ursodeoxycholic acid, an active ingredient used as the basis of drugs that are utilized for the treatment of severe and widespread liver diseases.

The decision to launch an investigation was notified today to the parties during inspections that were carried out in collaboration with the Antitrust Group of the Special Market Protection Unit of the Guardia di Finanza (Italian Tax Police).

According to a complaint by a competitor in the market for the production of the active ingredient ursodeoxycholic acid, the company ICE was abusing its dominant position in the production of cholic acid by the application of substantial price increases for the supply of this product and generally making its supply more difficult. ICE, through its subsidiary PCA, had also resorted to selective offers of ursodeoxycholic acid, i.e. sales that were particularly convenient and that were reserved to clients of the complainant company.

According to preliminary market estimates, ICE is the leader in the world market of cholic acid with a share of 70% while the subsidiary PCA has a world market share of 46% of the production and sale of ursodeoxycholic acid.

The investigation will establish whether the conduct of ICE and PCA constitutes an abusive strategy meant to alter the competitive structure of the market by means of the elimination of one of the main competitors in the production of the active ingredient to the detriment of intermediate consumers – pharmaceutical companies engaged in the production of drugs that are based on ursodeoxycholic acid, deprived of the availability of one of their suppliers – and the final consumers of these drugs.

Proceedings must be concluded by 30^th November 2014.

Rome, 17^th December 2013