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Emergent hopes to answer U.S. FDA on Baltimore plant within days

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By Michael Erman and Trisha Roy

(Reuters) - Contract drugmaker Emergent BioSolutions Inc said on Thursday it hopes to respond to U.S. regulators within days on how to resolve the problems at its Baltimore plant, which have forced Johnson & Johnson to largely halt U.S. manufacturing of their COVID-19 vaccine.

The U.S. Food and Drug Administration stopped J&J's vaccine production at the plant earlier this month while it investigates an error that led to millions of doses being ruined last month.

Emergent had to toss a batch of the J&J vaccine in March after it became contaminated with part of AstraZeneca Plc's COVID-19 vaccine, which it was also making at the plant.

The United States has put J&J in charge of the plant and has stopped the British drugmaker from using it.

Emergent Chief Executive Robert Kramer said he is hopeful the company's response to the FDA will meet or exceed their standards.

"We appreciate constructive, ongoing dialogue with Johnson & Johnson and their support as we work on a path forward," Kramer said on a conference call with investors. "If the FDA is comfortable with the approach we propose, I am hopeful that we can soon return to producing tens of millions of doses per month."

Kramer said he does not expect that the FDA will have to re-inspect the plant after the company submits its response, but conceded that it was still a possibility.

The company also disclosed that Sean Kirk, one of the executives in charge of the company's manufacturing operations, was taking a leave of absence. Another executive, Syed Husain, who runs the company's contract development and manufacturing unit, is leaving Emergent.

Despite the issues, Emergent beat first-quarter profit estimates, helped by U.S. government funding for vaccine production. It trimmed its full-year forecast, though, due to the issues at the plant.

Emergent lowered its 2021 revenue forecast to a range of $1.7 billion to $1.95 billion from its previous forecast of $1.95 billion to $2.05 billion. It also lowered its net income forecast for the year to $395 million to $470 million, from $475 million to $525 million previously.

In the first quarter, Emergent's net income was $69.7 million, or $1.28 per share, for the quarter, versus a loss of $12.5 million, or 24 cents per share, a year earlier.

Excluding items, Emergent earned $1.53 per share, ahead of estimates of $1.12 per share. Quarterly revenue rose 78.2% to $343 million.

(Reporting by Trisha Roy in Bengaluru and Michael Erman in New York; Additional reporting by Carl O'Donnell in New York; Editing by Bill Berkrot and Matthew Lewis)

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