Holly Springs plant licensed for cell-culture flu vaccines

Jun. 16, 2014 @ 06:54 PM

The U.S. Food and Drug Administration has licensed Novartis’ Holly Springs vaccine production plant to make cell-culture influenza vaccines, the company announced Monday.

With the licensure, the company’s flu virus vaccine Flucelvax will be produced in the United States for the first time.  Flucelvax has been produced in Marburg, Germany, a spokeswoman said in an email.

The Holly Springs facility is a result of a joint partnership between Novartis and the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority.

Novartis spokeswoman Liz Power said Novartis was awarded multiple contracts for the construction of the Holly Springs site, as well as for the development of flu cell culture for the Flucelvax vaccine and for pandemic influenza vaccines. Novartis also has contracts to develop and test vaccines and manufacture bulk stockpiles of antigens and adjuvants for pandemic threats.

The Swiss pharmaceutical firm is looking to sell its flu vaccine business part of a major overhaul of its business, however.

Earlier this year the company announced that it has agreed to buy GlaxoSmithKline’s cancer-drug business for $14.5 billion, plus up to $1.5 billion more if certain milestones are met. To GlaxoSmithKline, Novartis agreed to sell most of its vaccines business for $7.1 billion, plus royalties. The sale would not include its influenza vaccine portfolio.

Separately, the company had planned to invite bids for a sale of its flu business.

Power said the company has opened a competitive bidding process to find a new owner of the business, including the partnership with the U.S. government for the plant.  About 800 people work at the site, including 240 contractors.

“We cannot speculate on the process or its outcome,” she said.