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NEW YORK (MarketWatch) -- Chiron Corp. said the U.S. Food and Drug Administration is conducting a full inspection of its facility in Liverpool, England, that makes the Fluvirin flu vaccine.
The Emeryville, Calif., biotech company (CHIR: news, chart, profile) said the outcome of the inspection may not be communicated for several weeks after the inspections are completed.
Chiron expects to produce 18 million to 26 million Fluvirin doses for the 2005-06 influenza season.
Separately, Chiron cut its expectations for its Begrivac flu vaccine for the 2005-06 flu season by two-thirds, to 4 million doses from 12 million.
In addition, the shipment of the vaccine may be delayed until early October.
The company said it discovered several flu-vaccine lots didn't meet sterility guidelines, and it is working with German regulators to complete additional testing.
While Chiron doesn't expect any Begrivac sales in the third quarter, the company continues to expect 2005 earnings to be within previous forecasts.
Chiron also said the FDA determined the company's New Drug Application for Pulminiq, designed to prevent rejection of lung transplants, is approvable. But the FDA has asked for more information to confirm the drug's efficacy. The company is evaluating its response for Pulminiq.
source: http://www.marketwatch.com/news/print_story.asp?print=1&guid={C9D44BCE-EC51-470B-AA98-89C13A77BF57}&siteid=google 15jul2005
EMERYVILLE, CA — The company is working to cover BEGRIVAC vaccine shortfall with other non-U.S. influenza virus vaccines. There is no change to financial guidance
Chiron Corporation (Nasdaq:CHIR) today announced that it has reduced its supply expectations for its BEGRIVAC(TM) influenza virus vaccine for the 2005-2006 influenza season by approximately 8 million doses and may delay shipments until early October. Chiron had expected to supply approximately 12 million doses of BEGRIVAC vaccine to customers outside of the United States. Chiron now expects to supply approximately 4 million doses of BEGRIVAC vaccine in these markets. BEGRIVAC vaccine is manufactured at Chiron's facility in Marburg, Germany.
In conducting its regular internal quality assurance tests, Chiron identified a small number of lots of the BEGRIVAC vaccine that did not meet product sterility specifications. Chiron has taken presumptive corrective action, and is working closely with the German regulatory agency, the Paul Ehrlich Institute (PEI), to complete additional testing in order to determine the full extent of the issue. Chiron will not release any BEGRIVAC vaccine until those tests are complete. It is possible that the timing or results of such additional tests, or any additional manufacturing or regulatory developments, may result in Chiron being unable to supply any BEGRIVAC vaccine doses to non-U.S. markets this season.
Chiron manufactures influenza vaccine in two facilities for Europe and other non-U.S. markets. Chiron's facility in Marburg produces BEGRIVAC vaccine predominantly for the German and UK markets, and Chiron's facility in Siena/Rosia, Italy, produces AGRIPPAL(R) S1 influenza virus vaccine and FLUAD(R) influenza virus vaccine. Chiron is working to mitigate the impact of the reduced supply of BEGRIVAC vaccine by reallocating non-U.S. vaccine doses among affected markets, and by allocating the shipment of the company's non-U.S. influenza virus vaccines from extra production in Siena.
Chiron does not expect to record any sales of BEGRIVAC vaccine in the third quarter of 2005. However, Chiron still expects to be within the range of its updated 2005 financial guidance of income from continuing operations of between $1.20 and $1.45 per share on an adjusted (pro forma) basis and between $0.86 and $1.11 per share on a GAAP basis. Chiron management uses adjusted financial statements to gain an understanding of the company's operating performance on a comparative basis. Adjusted guidance excludes amortization expense on acquired intangible assets related to the acquisitions of PathoGenesis, Chiron Behring, Pulmopharm and PowderJect Pharmaceuticals, totaling approximately $0.34 per share.
About Chiron
Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information, please visit www.chiron.com.
This news release contains forward-looking statements, including statements regarding supply of BEGRIVAC(TM) influenza virus vaccine and other influenza virus vaccines that Chiron expects to deliver to non-U.S. markets, and assumptions regarding supply of FLUVIRIN(R) influenza virus vaccine that Chiron expects to deliver to the U.S. market, in future influenza seasons, sales and earnings expectations and improvements to manufacturing facilities, that involve risks and uncertainties and are subject to change. A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended March 31, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including, among others, additional adverse developments resulting from the suspension of Chiron's UK license to manufacture FLUVIRIN vaccine from October 5, 2004, through March 2, 2005, the announcement of such suspension and the litigation and investigations relating to those matters, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, litigation, stock-price and interest-rate volatility, marketing effectiveness, and the severity of the 2005-2006 influenza season. In particular, there can be no assurance that additional issues with respect to the BEGRIVAC or FLUVIRIN vaccines or Chiron's manufacturing generally will not arise in the future or that Chiron will be able to sell BEGRIVAC for the 2005-2006 influenza season, will be able to cover vaccine shortfalls, or will successfully address matters raised in a warning letter from the FDA with respect to its FLUVIRIN vaccine manufacturing facility or resume sale of FLUVIRIN vaccine for the 2005-2006 influenza season. In addition, the company may face additional competition in the influenza market in the future and challenges in distribution arrangements as a result of the recent BEGRIVAC and FLUVIRIN vaccine developments. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, shareholder and regulatory approvals, and the integration of operations.
Chiron does not undertake an obligation to update the forward-looking information the company is giving today.
NOTE: AGRIPPAL, BEGRIVAC, FLUAD and FLUVIRIN are trademarks of Chiron Corporation.
source: http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20050715005151&newsLang=en 15jul2005
Nine months after a contamination at its England plant interrupted supplies of influenza vaccine to the U.S. market, Chiron Corp. reported that some lots of a different flu vaccine didn't meet sterility specifications, causing Chiron to reduce sharply its supply forecast for non-U.S. markets.
The Emeryville, CA, company backed its 2005 earnings guidance despite the manufacturing glitch at a German plant, which may delay shipments of the Begrivac flu vaccine until early October. Chiron had expected to supply about 12 million doses of Begrivac vaccine to customers outside of the U.S., but now expects to supply just four million doses in those markets.
Separately, Chiron said the U.S. Food and Drug Administration is inspecting the company's Liverpool, England, plant, which was shut down in October after U.K. regulators found a bacterial contamination.
Chiron made Fluvirin flu vaccine at the plant, and needs the go-ahead from the FDA and U.K. regulators before it can resume production. Assuming approval, Chiron said it plans to produce 18 million to 26 million doses of Fluvirin for the 2005-2006 flu season.
Separately, the FDA wants an additional study before it would consider approving a proposed lung-transplant drug by Chiron, the company said Friday. The company said it received an "approvable" letter from the FDA for its lung-transplant drug, known as Pulminiq, that requested additional study.
"We will carefully review our options before making any decisions regarding the product," said Craig Wheeler, the president of Chiron BioPharmaceuticals. In morning trading Friday on the Nasdaq Stock Market, Chiron shares fell 92 cents, or 2.5%, to $36.35.
Sterility Problems
The reduction in Begrivac vaccine comes after quality-assurance tests at the company's Marburg, Germany, plant found "a small number of lots" of Begrivac flu vaccine didn't meet sterility specifications.
The Marburg plant makes Begrivac primarily for the U.K. and German markets. Chiron is trying to mitigate any negative impact from the reduced supply by shifting doses among the affected markets and utilizing extra production at the company's Sienna, Italy, plant.
Chiron won't release any Begrivac vaccine until additional tests have been run.
The company doesn't expect any sales of the vaccine in the third quarter, but said full-year company operating income from continuing operations will still come in within its previously issued guidance range of $86 cents to $1.11 a share. Adjusted operating earnings from continuing operations are expected between $1.20 and $1.45 a share. Analysts expect, on average, earnings of $1.31 a share, according to a Thomson First Call survey.
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