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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: John F. Dowd who wrote (7830)	6/9/1999 3:26:00 PM
From: Stephen	Respond to of 9523

Anyone watching the blocks being dumped ..... ?? Jimminee .. looks like something is up to me .....

To: John F. Dowd who wrote (7830)	6/9/1999 3:27:00 PM
From: Anthony Wong	Respond to of 9523

Pfizer Relabels Antibiotic Trovan for Serious Infections PR Wire June 9, 1999, 12:16 p.m. PT NEW YORK, June 9 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) said today it will be notifying prescribing physicians to limit the use of Trovan(R) (trovafloxacin) tablets and intravenous formulation to certain serious infections. This action follows discussions with the U.S. Food and Drug Administration regarding the agency's interpretation of spontaneous adverse event reports of rare serious hepatic events associated with Trovan observed in post-marketing surveillance. More than 2.5 million prescriptions have been written for Trovan, which was introduced in February 1998. Pfizer has received reports of 140 cases of hepatic adverse events worldwide from February 1998 through early May, all of which have been submitted to regulatory authorities. "The spontaneous adverse event reporting system is helpful in identifying rare adverse events, but data derived from these reports cannot be used exclusively to draw conclusions about a product's risk-benefit profile," said Joe Feczko, M.D., Pfizer's senior vice president of worldwide medical operations and regulatory affairs. "We have a difference of opinion with the agency over the interpretation of these data and the regulatory action being taken," he said. "Pfizer believes that this risk assessment requires additional scientific evaluation and analysis in order to provide physicians with the proper clinical guidance to use Trovan safely and effectively. Trovan has unique therapeutic advantages that are not shared by other commonly used antibiotics, and the degree of risk associated with Trovan use is not markedly different when compared with other widely used antibiotics such as penicillins," Dr. Feczko said. "The decreased mortality seen with Trovan versus comparative agents in controlled clinical trials would have been expected to result in the savings of a substantial number of lives based on prescribing to date," he added. Pfizer is continuing to collect medical information and conduct additional analyses to further understand the incidence of these events. The company will continue to work collaboratively with the FDA to ensure Trovan's appropriate use. "While these analyses continue, Pfizer believes it prudent and responsible to voluntarily limit the use of Trovan to serious in-patient infections where Trovan has an important role," Dr. Feczko said. "We will be widely communicating this new information about Trovan to the medical community, wholesalers and pharmacists as quickly as possible." Pfizer noted that these serious hepatic events were too rare to be observed among the approximately 7,000 Trovan patients in the clinical trials, which were among the largest ever conducted for an anti-infective medicine. Many of the severe hepatic cases reported appear to be due to a hypersensitive (allergic) type reaction. Additional medical factors, such as underlying illnesses and the use of other medications, may also have contributed to the reported liver problems. Pfizer vigilantly monitors the safety and use of all its medicines and shares this information with regulators and prescribers worldwide. Pfizer is in discussion with regulators outside the U.S. regarding Trovan relabeling and product utilization. Pfizer Inc is a research-based global pharmaceutical company that discovers, develops, manufactures and markets innovative medicines for humans and animals. The company reported revenues of more than $13.5 billion in 1998 and expects to spend about $2.8 billion on research and development this year. In 1999, Pfizer celebrates its 150th anniversary. SOURCE Pfizer Inc -0- 06/09/99 /CONTACT: Andy McCormick, 212-573-1226, or Mariann Caprino, 212-733-5686, both of Pfizer/ /Company News On-Call: Pfizer's press releases are available at no charge through PR Newswire's Company News On-Call fax service and on PRN's Web Site. For a menu of Pfizer press releases or to retrieve a specific release, call 800-758-5804, extension 688250, or prnewswire.com on the Internet./ /Photo: A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom, PC or Macintosh, that can accept overhead transmissions. To retrieve a logo, please call 972-392-0888./ /Web site: pfizer.com

To: John F. Dowd who wrote (7830)	6/9/1999 3:33:00 PM
From: Anthony Wong	Respond to of 9523

John, Trovan is considered to be one of PFE's more promising drugs. In any case, overreactions to adverse news is nothing new in PFE trading. Would we see $100 again?

To: John F. Dowd who wrote (7830)	6/9/1999 3:35:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 9523

Update from Bloomberg: Pfizer's Trovan Use Should Be Limited, FDA Says (Update1) Bloomberg News June 9, 1999, 3:24 p.m. ET Pfizer's Trovan Use Should Be Limited, FDA Says (Update1) (Adds comments from Pfizer, details on the FDA advisory, background on Trovan. Updates share price.) Washington, June 9 (Bloomberg) -- Pfizer Inc.'s Trovan antibiotic should only be used to treat patients with serious or life-threatening illness because of concerns about liver problems, the U.S. Food and Drug Administration said. The FDA said the drug's use -- especially in its oral form -- should be restricted to limited group of patients whose infections are severe enough to outweigh the risk of liver damage. The notice to physicians comes after 14 reported cases of liver failure in patients taking the drug, the FDA said. Six patients died and four received liver transplants. Pfizer said it will work with doctors, pharmacists and wholesalers to limit distribution of the drug. ''Pfizer believes it is prudent and responsible to voluntarily limit the use of Trovan to serious patient infections where Trovan has an important role,'' said Joe Feczko, Pfizer's senior vice president for worldwide medical operations, in a statement. Trovan is an important product for Pfizer, the No. 2 U.S. drugmaker, and had sales of $160 million in 1998, its first year on the market after being approved in December 1997. Pfizer shares fell 5 1/2 to 105 1/2 in afternoon trading. Feczko said the company didn't believe that there was yet sufficient evidence of liver problems to merit the FDA's wraning to doctors, noting that none of 7,000 patients treated with the drug in clinical trials show evidence of liver problems. The FDA advised doctors to limit Trovan use to patients who meet a strict set of criteria. The agency said doctors should give the drug only to patients who have a serious or life threatening infection, begin treatment in a hospital or nursing care facility and start patients on the drug only when the benefit to the patient outweighs the risk of liver damage. Label Restrictions Last month, Pfizer, the U.S.'s No. 2 drugmaker, said Trovan would get stronger label restrictions in the U.S. and Europe. Last week, Public Citizen, a citizen's advocacy group, called on the FDA to withdraw the drug from the market, saying that the drug ''had no unique benefits and unquestionable unique life- threatening risks.''