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BioMarin / Amicus Merger Approved Under EU Regulation

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Summary

The European Commission approved BioMarin Pharmaceutical Inc.'s acquisition of sole control over Amicus Therapeutics Inc. under Article 6(1)(b) of Council Regulation (EC) No 139/2004. The Commission determined the transaction qualifies for simplified treatment and declared it compatible with the internal market and the EEA Agreement. BioMarin and Amicus are both US-based global biotechnology companies specialising in therapies for rare genetic diseases.

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What changed

The European Commission issued a clearance decision for BioMarin Pharmaceutical Inc.'s proposed acquisition of Amicus Therapeutics Inc., both US-based biotechnology companies. The Commission determined the transaction falls within the scope of the simplified treatment procedure under Article 6(1)(b) of the EU Merger Regulation and declared it compatible with the internal market and the EEA Agreement.

Affected parties (the merging biotechnology companies and their investors) may proceed with the transaction as approved. This decision represents a routine merger clearance under the EU's simplified procedure, which applies to concentrations that do not raise competition concerns. No new compliance obligations are imposed beyond standard post-merger reporting requirements.

Archived snapshot

Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Case M.12314 - BIOMARIN PHARMACEUTICAL /

AMICUS THERAPEUTICS

Only the English text is available and authentic. REGULATION (EC) No 139/2004

MERGER PROCEDURE

Article 6(1)(b)

Date: 01/04/2026 In electronic form on the EUR-Lex website under document number 32026M12314

EUROPEAN COMMISSION

DG Competition

Brussels, 1.4.2026 C(2026) 2356 final

PUBLIC VERSION

BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 United States

Subject: Case M.12314 - BIOMARIN PHARMACEUTICAL / AMICUS THERAPEUTICS Commission decision pursuant to Article 6(1)(b) of Council Regulation (EC) No 139/2004 ( ) and Article 57 of the Agreement on the European 1 Economic Area ( ) 2

Dear Sir or Madam, (1) On 10 March 2026, the European Commission received notification of a proposed concentration pursuant to Article 4 of the Merger Regulation following a referral pursuant to Article 4(5) of the Merger Regulation, by which BioMarin

Pharmaceutical Inc. ("BioMarin", United States), will acquire within the meaning

of Article 3(1)(b) of the Merger Regulation sole control over Amicus

Therapeutics Inc. ("Amicus", United States) by way of purchase of shares. ( ) 3

(2) The business activities of the undertakings concerned are the following:

  • BioMarin (Nasdaq: BMRN) is a global biotechnology company engaged in

the research, development, manufacturing and commercialisation of pharmaceutical products for the treatment of several rare genetic diseases such as CLN2 (Batten) disease and Morquio A syndrome,

  • Amicus (Nasdaq: FOLD) is a global biotechnology company specialising

in the development and commercialisation of therapies for rare diseases, including Fabry disease and Pompe disease. (3) After examination of the notification, the European Commission has concluded that the notified operation falls within the scope of the Merger Regulation and of

() OJ L 24, 29.1.2004, p. 1 (the 'Merger Regulation'). With effect from 1 December 2009, the Treaty 1

on the Functioning of the European Union ('TFEU') has introduced certain changes, such as the replacement of 'Community' by 'Union' and 'common market' by 'internal market'. The

terminology of the TFEU will be used throughout this decision. () OJ L 1, 3.1.1994, p. 3 (the 'EEA Agreement'). 2 () OJ C, C/2026/1745, 17.3.2026. 3

EUROPEAN COMMISSION

paragraph 5(c) of the Commission Notice on a simplified treatment for certain concentrations under Council Regulation (EC) No 139/2004. ( ) (4) For the reasons set out in the Notice on a simplified treatment, the European Commission has decided not to oppose the notified operation and to declare it compatible with the internal market and with the EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the Merger Regulation and Article 57 of the EEA Agreement.

For the Commission

(Signed)

Linsey MCCALLUM

Director-General (acting) Directorate-General for Competition

() OJ C 160, 5.5.2023, p. 1 (the 'Notice on a simplified treatment'). 4

Named provisions

Article 6(1)(b) Article 3(1)(b) Article 4 Article 57 of the EEA Agreement Notice on simplified treatment

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Last updated

Classification

Agency
EC
Published
April 1st, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
C(2026) 2356 final - Case M.12314
Docket
M.12314

Who this affects

Applies to
Pharmaceutical companies Investors Public companies
Industry sector
3254 Pharmaceutical Manufacturing 3254.1 Biotechnology
Activity scope
Merger review Concentration clearance Corporate acquisition
Geographic scope
European Union EU

Taxonomy

Primary area
Antitrust & Competition
Operational domain
Legal
Topics
Healthcare Intellectual Property

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