Crucell’s Plant Shutdown to Be Reviewed by Korean FDA, Crucell
Release Date: 2010-11-02
The Korea Food & Drug Administration will review Crucell NV’s investigation into possible contamination at a vaccine plant before deciding whether to undertake its own probe of the situation.
Crucell told the South Korean regulator on Oct. 28 that the company had discovered “problems” at the Shingal facility and was investigating, Nam Tae Kyun, an official at the KFDA’s biopharmaceuticals policy division, said in a telephone interview yesterday. He didn’t provide details on the nature of the problem, nor has the Leiden, Netherlands-based company.
The agency expects to receive Crucell’s report this month, Nam said. The World Health Organization also is looking into the matter, a spokeswoman for the Geneva-based group said. Only two batches of vaccine may have been affected, and it isn’t yet known how they became “compromised,” said Alison Brunier, the WHO spokeswoman. The Korean regulator will inspect the facility sometime this month, she said, declining to give an exact date.
“I don’t have the impression there is much concern about supply of pentavalent vaccines in general at this point,” Brunier said today in a telephone interview. The agency, a unit of the United Nations, in 2006 “pre-qualified” the Quinvaxem vaccine, a prerequisite for sales to supranational organizations such as the United Nations Children’s Fund.
Crucell, which agreed last month to be acquired by Johnson & Johnson for about 1.75 billion euros ($2.4 billion), said Oct. 28 that it halted production and shipments of two vaccines because sterile operation of the Shingal facility “may have been compromised.” Shipments of the Quinvaxem shot for five childhood infectious diseases and the hepatitis B vaccine Hepavax-Gene should resume before the end of November, after the investigation, Crucell said Oct. 28.
J&J Response
J&J “is working with Crucell to understand the circumstances surrounding these events and to assess the situation,” the two companies said in a separate statement Oct. 29.
There are no safety concerns with vaccines that have already been distributed, Crucell has said. Crucell declined to comment about the nature of the problem at the plant while the internal investigation continues.
Unicef ordered $110 million of Crucell’s Quinvaxem vaccine in May to supply the developing world. Unicef distributes so- called pentavalent vaccines -- which provide inoculation against five childhood illnesses in one shot -- in 65 countries, and Crucell is one of four suppliers, Joan Howe, a spokeswoman for Unicef in Copenhagen, said by e-mail yesterday.
The others are GlaxoSmithKline Plc, Panacea Biotech Ltd., and the Serum Institute of India Ltd., she said.
Limited Shipments
Shipments may be limited through the end of January because of the production shutdown, Crucell said last week. The company withdrew its 2010 financial forecast. Crucell said it’s “positive” it can resume manufacturing as early as this month.
J&J, which owns 18 percent of Crucell, said Oct. 6 it would buy the rest of the company for 24.75 euros a share. Crucell shares closed down 1 cent at 23.06 euros in Amsterdam. The stock has surged 66 percent this year, compared with a 2.6 percent return for the Bloomberg Europe Pharmaceutical Index including reinvested dividends.
Quinvaxem protects children against diphtheria, tetanus, whooping cough, hepatitis B and the pathogen that causes meningitis and pneumonia.
To contact the reporters on this story: Frances Yoon in Seoul at fyoon2@bloomberg.net; Phil Serafino in Paris at pserafino@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net
| Type: | NORMAL |
| Company: | Crucell |
| Country: | 荷兰 |
| Url: | http://www.bloomberg.com/news/2010-11-02/crucell-s-report-on-plant-shutdown-to-be-reviewed-by-korean-fda.html |