EU Regulators Scrutinize Novo Holdings' Catalent Acquisition

Earlier this year, the FTC requested additional information regarding Novo Holdings’ proposed acquisition of Catalent, but now, the EU antitrust regulators have announced they are probing the deal for anti-competitiveness impacts surrounding injectables, pre-filled syringes, orally dissolved pills and soft gels.

The focus will investigate how Novo Nordisk plans to use Catalent's capabilities to boost production of Wegovy, with the EU Commission's review expected by December 6th.

The following article originally appeared in Reuters.

EU antitrust regulators have asked pharma rivals and customers for feedback in four business areas in light of Novo Holdings' planned $16.5 billion takeover of Catalent (CTLT.N), people familiar with the matter said.

Novo Holdings is the controlling shareholder of Danish drugmaker Novo Nordisk (NOVOb.CO), whose profits from blockbuster weight-loss drug Wegovy propelled it to become Europe's most valuable company by market value.

While the questionnaire shows the European Commission seeking to understand the market, it could allow rivals and customers to flag potential anti-competitive concerns.

The questionnaire seeks feedback on vertical links in parts of the contract development and manufacturing organisation (CDMO) industry, including injectables, pre-filled syringes orally dissolved pills, and soft gels, the sources said.

The regulator distributed it to big pharma and CDMO companies, the sources said. This came after Novo Holdings put in a request for EU approval for the deal on Oct. 31.

The EU watchdog has set a Dec. 6 deadline for its preliminary review. Novo Holdings has until Nov. 29 to offer remedies during this phase, if any are required.

European Union regulators can either clear the deal with or without remedies, or open a full-scale, four-month investigation if they have serious concerns.

The $16.5 billion deal, announced in February, underscores Novo Nordisk's drive to boost output of Wegovy, a once-weekly injection.

After the deal closes, Novo Holdings will sell three of Catalent's fill-finish sites - in Italy, Belgium and the United States - onto Novo Nordisk for $11 billion. The sites will then by fully used by Novo Nordisk for filling its injection pens.

Novo Holdings, Novo Nordisk and Catalent all recently reiterated their expectations that the transaction will close towards the end of this year.

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