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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (13312)	10/5/2004 1:08:00 PM
From: fred hayes	Read Replies (1) \| Respond to of 52153

Peter: Agreed that this makes MEDI look more attractive, but a simpler approach may be CHIR at a 20 percent discount. I don't follow the company closely, but I can't see it being worth 20 percent less today than yesterday because of a one-year flu vaccine problem. And I'm wondering whether the problem could still be resolved for this year. I wonder if this could be some kind of brinkmanship play to put on pressure to resolve the issues rather than a final decision that precludes vaccine for this season. I stress that I have no idea of the answer... fred

To: Biomaven who wrote (13312)	10/6/2004 9:31:59 AM
From: rkrw	Read Replies (1) \| Respond to of 52153

Bank of America out with est that medi benefit from chiron debacle could be 2-6 cents/share in 04 eps. Base this on mfg 2M doses, but guiding pre chir to selling 450K. Now likely to sell out.

To: Biomaven who wrote (13312)	10/7/2004 7:14:34 AM
From: Doc Bones	Read Replies (1) \| Respond to of 52153

Chiron shares, credibility suffer BIOTECH FIRM'S STOCK VALUE DECLINES 16% In the GLIA debacle it was the [continental] Europeans who were too lackadaisical, not realizing that the FDA was dead serious. The roles seem reversed here. Perhaps the mad cow, hoof and mouth, etc. problems have stiffened the upper lips and standards. Doc Posted on Wed, Oct. 06, 2004 By Paul Jacobs Mercury News Chiron's share price dipped and its credibility suffered a devastating blow Tuesday when the British government blocked the company's plans to deliver up to 48 million doses of flu vaccine to the United States just as the nation's flu season is starting. The decision comes just days after the Emeryville company's chief executive assured Congress that it had resolved problems at its Liverpool, England, plant that had delayed distribution of its Fluviron vaccine. Chiron Chief Executive Officer Howard Pien said he and others at the company were surprised early Tuesday to learn that British regulators would deny a license to the vaccine. He said earnings for 2004 would drop sharply as a result, prompting a 16 percent drop in Chiron shares. In separate news conferences, Chiron executives and U.S. public health officials made it clear that the British regulators had been much more aggressive than their U.S. counterparts in identifying problems at the manufacturing facility. That plant, acquired by Chiron a year ago, is the only source of the company's vaccine for the United States; it produced almost half of the flu vaccine U.S. officials were expecting for the coming flu season. ``This is a painful event for Chiron,'' Pien said. ``We profoundly regret we will be unable to meet public health needs this influenza season.'' Pien said he thought the company had identified the ``root cause'' of the contamination when the problem was first disclosed in August, and that it had affected only a small number of batches of vaccine. The problem, he said, was ``human error'' -- a problem in handling the vaccine in one of the roughly 12 steps involved in making it. Chiron has not said what the problem was, but Dr. Jesse L. Goodman, a U.S. Food and Drug Administration official, said Tuesday that Serratia, a disease-causing bacteria, was the contaminant. On Sept. 28, in testimony before a Senate committee, Pien said he was confident the problem had been corrected and that the company was on target to release the vaccine early this month, in time for the flu season. But the United Kingdom's Medicines and Health Care Products Regulatory Agency refused to issue a license to export the vaccine. Most of Chiron's Fluviron vaccine remains in England. ``The products will be destroyed in due course,'' Pien said. However, U.S. Health and Human Services Secretary Tommy Thompson said Tuesday at a government news conference that he is dispatching a team to meet with British regulators and inspect the Chiron plant. He and other U.S. public health officials left open the possibility that some or all of the vaccine might still be released. What became clear Tuesday was the difference in how regulators in the United States and the United Kingdom view their role in regulating vaccine production. From the start, the FDA relied on the company to identify the contamination problem and correct it, while the British agency inspected the facility to do its own analysis. The FDA's Goodman said his agency had an inspection team at the plant ``for other purposes'' in the summer when the problems first surfaced, but that the agency was waiting for ``a complete analysis of the root cause'' from Chiron before determining whether the vaccine could be released. In contrast, Chiron's Pien said British regulators inspected the plant twice in the past several weeks before concluding that problems remained and that the vaccine couldn't be exported. Pien did not explain in detail what British officials found in their inspections. But he said he was hopeful all the issues could be resolved in time to begin producing vaccine for next year's flu season. He said he and other Chiron executives kept in close touch with regulators and public health officials in both countries as the company pinned down what it believed to be the source of contamination. Without the Chiron vaccine, the United States is left with 54 million doses from Aventis Pasteur and 1 million to 2 million doses of FluMist, a nasal vaccine from MedImmune Vaccines in Mountain View. But FluMist has been approved only for flu prevention in healthy individuals between 5 and 49, a group at relatively low risk of the sometimes deadly complications of the flu. Chiron had been expecting earnings of $1.50 to $1.60 a share for 2004. But with the loss of Fluviron sales, the range would dip to 35 to 45 cents -- a loss of more than 70 percent. Trading in Chiron stock on the Nasdaq Stock Market was suspended Tuesday morning until after the company made its announcement. Chiron shares closed at $37.98, down $7.44 after a shortened trading day. Several analysts said this was a one-time event, as long as the company is able to satisfy regulators before production begins on next year's vaccine. But, says Robert W. Baird & Co. analyst Aaron Geist: ``Some management credibility issues have to be addressed. Management has to rebuild investor confidence.'' Geist owns no Chiron shares, but his company hopes to do investment-banking business with the company in the future. mercurynews.com [free reg.]