J&J says large study of coronavirus vaccine could begin in September

By Manas Mishra and Carl O'Donnell

(Reuters) - Johnson & Johnson said on Thursday it is aiming to begin in September a late-stage study of its experimental vaccine for the novel coronavirus, as researchers work at break-neck speed to develop a shot to combat the fast-spreading pathogen.

The New Brunswick, New Jersey-based healthcare conglomerate, which expects to start human trials of its vaccine this month, lags other companies that also are developing coronavirus vaccines, with Moderna Inc expected to begin a late-stage study on July 27.

"Our initial data on the phase I will be available second half of September, which will become the basis for a phase III study. And that will start mid-to-end September," J&J Chief Scientific Officer Paul Stoffels said during a post-earnings conference call.

Phase I clinical trials test a drug's safety in people. Phase II trials establish more about how safe a drug is and how well it works. Larger phase III trials are the last stage before seeking regulatory approval if a drug proves safe and effective.

Researchers reported on Tuesday that Moderna's experimental vaccine showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study.

Early-stage human trial data on a vaccine being developed by AstraZeneca and Oxford University will be published on July 20.

J&J on Thursday also reported better-than-expected quarterly earnings and raised its full-year profit forecast, helped by strength in its pharmaceuticals unit.

Sales of J&J's devices used in medical procedures dropped nearly 34% as hospitals delayed non-urgent surgeries such as hip and knee replacement due to the coronavirus pandemic. But the company said that some economies had started to open up earlier than expected, helping sales of $4.39 billion beat analysts' consensus of $3.43 billion, according to Wells Fargo.

Sales in J&J's large pharmaceuticals unit rose 2.1% to $10.75 billion, helped by demand for Stelara, used to treat Crohn's disease, and the company's cancer treatments.

J&J raised its full-year adjusted profit forecast to $7.75 to $7.95 per share, from its prior estimate of $7.50 to $7.90 per share.

The company reported net earnings of $3.63 billion, or $1.36 per share, in the second quarter, down from $5.61 billion, or $2.08 per share, a year earlier.

Excluding items, J&J earned $1.67 per share, beating the average analyst estimate of $1.49, according to Refinitiv estimate.

Shares of the company were flat at $147.99.

(Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Will Dunham)