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EU has set Dec. 6 deadline for preliminary review of deal

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Novo, Catalent ( CTLT ) expect deal to close towards year-end

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US regulators have also sought information on the deal

By Foo Yun Chee and Maggie Fick

BRUSSELS/LONDON, Nov 13 (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 ), people familiar with the

matter said.

Novo Holdings is the controlling shareholder of Danish

drugmaker Novo Nordisk, 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 ( CTLT ) 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 ( CTLT ) all recently

reiterated their expectations that the transaction will close

towards the end of this year.

In May, the companies said they had received a second

request from the U.S. Federal Trade Commission (FTC) for more

information on the deal. There has been no update from the FTC

on its review of the deal since then.

Novo Nordisk faces competition from U.S. rival Eli Lilly's ( LLY )

injection Zepbound in the fast-growing obesity drug race. Some

analysts have estimated the market could be worth as much as

$150 billion by the early 2030s.

U.S-based Catalent ( CTLT ), one of the world's largest contract

manufacturers, made a huge windfall during the COVID-19 pandemic

as it was contracted to help make vaccines by several companies.

But the company faced a range of problems in the pandemic's

aftermath, as COVID-vaccine revenue fell and its costs increased

due to actions to address quality control lapses identified

during inspections by U.S. drug regulators at three plants.