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


To: Biomaven who wrote (8011)3/12/2003 6:12:24 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
FDA gets serious about Reg FD:

Reuters
UPDATE - Schering-Plough, Kogan may face SEC charges
Wednesday March 12, 5:20 pm ET
By Ransdell Pierson

NEW YORK, March 12 (Reuters) - Schering-Plough Corp. (NYSE:SGP - News) on Wednesday said the U.S. Securities and Exchange Commission (News - Websites) will likely charge the company and its chief executive, Richard Kogan, with improperly releasing material information to select investors.

Schering-Plough said the likely civil charges concern violations of a federal law called Regulation FD, which prohibits companies from making selective disclosures of important information. The SEC has only infrequently taken action for violations of the 2-year-old regulation.
"I think it's fairly serious stuff," said Henry Astarjian, an analyst for Norwich Union Investment Management.
Kogan met with select investors and analysts on at least two occasions over three days in October 2002, during which the company's shares fell 20 percent.
The reasons for the decline have never been explained. Kogan met with portfolio managers of Putnam Investments in Boston, one of its biggest shareholders, only minutes before the sell-off began at 2:45 p.m. on Tuesday, Oct. 1. More than 19 million shares exchanged hands by the end of that day, three times the stock's normal daily volume.
Although investors and industry analysts marveled at the huge trading volumes on all three days of the sell-off, the company declined to comment.
On Thursday of that period, as shares continued to slump, the company held an invitation-only meeting with about 24 analysts and fund managers at its headquarters in Kenilworth, New Jersey. The news media was not allowed to attend.
Analysts later told Reuters they were shocked that Kogan had told them earnings in 2003 would be "terrible," although the company had never before given public earnings forecasts for that year.
PRIVATE MEETING, THEN BOMBSHELL
Late in the evening, 10 hours after the private meeting broke up, the company said its earnings in 2003 and 2004 would be far below Wall Street expectations due to the looming patent expiration on its top allergy drug Claritin. The bombshell warning sent shares to depths not seen since late 1996.
On Oct. 7 Schering-Plough said the SEC was investigating the private meetings. Kogan announced the following month he would give up his CEO post by April.
"The day Kogan was in Boston I knew he was meeting with certain large shareholders," said David Sobell, an analyst at Pioneer Investment Management Inc. who was not on the select list. "It was all very suspicious from the beginning."
"The fact that the SEC is serving a Wells notice obviously suggests they found enough information to move forward."
Norwich Union's Astarjian said he is looking forward to a change of management at Schering-Plough.
"We're looking for strong and honest leadership. Their management hasn't been very open over the past few years and that's what investors are looking for," the analyst said.
Schering-Plough on Wednesday said it has "an opportunity to file a legal brief setting forth its views on the matter under investigation."
Neither Kogan nor Putnam were immediately available for comment. SEC officials declined to comment.
The only SEC actions taken under Regulation FD have consisted of cease-and-desist orders against three companies: Secure Computing Corp., Raytheon Co. and Siebel Systems Inc. The three companies did not admit or deny the allegations. Only Siebel was fined, for $250,000.
All three investigations were prompted by what the SEC considered improper private communications with analysts. Motorola Inc. was also investigated by the SEC, but not sanctioned.
Schering-Plough shares closed down 13 cents to $15.75 Wednesday on the New York Stock Exchange (News - Websites), after hitting a new 6-year low of $15.35 earlier in the session.
The stock has plunged almost 70 percent since early 2001, when the company disclosed quality control problems at its plants that have delayed approvals of new medicines. Analysts and consumer groups have accused Kogan of ignoring the problems until U.S. regulators demanded they be fixed.
Shares have also been hurt by the recent U.S. patent expiration on Schering-Plough's popular allergy drug Claritin, which is now sold without a prescription for barely a third the pill's original price. Moreover, the company's hepatitis drugs are facing new competition from products sold by Swiss drugmaker Roche Holding AG (ROCZg.VX). (Additional reporting by Toni Clarke and Jed Seltzer)


Peter



To: Biomaven who wrote (8011)3/13/2003 12:36:36 AM
From: Robohogs  Respond to of 52153
 
Aww man - just as I get ready to move to Hong Kong. Ouch! Bad news just keeps following me around (seriously, I hope this outbreak shuts off). As for your SGP notice, you meant SEC not FDA (I think). I am ever so thankful I sold this one at $23 when the Merck/SGP drug approval/rumors came out. Ouch!!!

Jon



To: Biomaven who wrote (8011)3/15/2003 4:55:18 PM
From: Doc Bones  Read Replies (1) | Respond to of 52153
 
World Health Alert Issued After Man With Symptoms of Killer Pneumonia Quarantined in Germany

By Margie Mason Associated Press Writer
Published: Mar 15, 2003


The World Health Organization warned a mysterious form of pneumonia was becoming a "worldwide health threat" Saturday, as a case of the illness was suspected in Europe for the first time.
In a rare "emergency travel advisory," the health agency said it has received more than 150 reports of acute respiratory syndrome in the past week.

On Saturday, a doctor believed to have the atypical form of pneumonia was taken off a New York to Singapore flight during a stopover in Germany and quarantined in a Frankfurt hospital. His two travel companions also were hospitalized.

Another 155 passengers aboard his flight were quarantined at the Frankfurt airport but some of them were released.

Most cases of the illness involve medical workers in east Asia but the illness has shown signs of spreading. Three people are confirmed to have died from it, including an American businessman. Five other people died recently of similar symptoms in southern China but it was not clear if the illness was the same.

"Until we can get a grip on it, I don't see how it will slow down," WHO spokesman Dick Thompson said in Geneva. "People are not responding to antibiotics or antivirals, it's a highly contagious disease and it's moving around by jet. It's bad."

The unidentified doctor, who is from Singapore, had treated a patient with the illness before traveling to New York to attend a conference, said Dr. Angela Wirtz, a health official in the German state of Hessen. He began to suffer symptoms while in New York, she said in a statement.

Two people, his wife and another doctor, were still being held for observation the Wolfgang Goethe University Clinic in Frankfurt.

There was concern the doctor may have infected others on board.

Another 155 passengers who deplaned in Frankfurt were held in quarantine at the airport. German nationals were released while passengers from other nations in transit to other cities in Europe were awaiting travel permission from those countries, German health officials said. They did not give a breakdown of number of travelers or destinations.

Eighty-five people bound for Singapore and the plane's 20-member crew continued their journey, but they will be quarantined on their arrival in Singapore, health officials said.

In an advisory sent to airlines, the WHO urged travelers who may have come in contact with someone infected to watch for symptoms such as high fever, coughing and shortness of breath.

The advisory did not call for restrictions on travel to any destination but said people who suspect they may have the illness should seek medical attention and not travel until they recover.

Thompson said he could not remember the WHO issuing such a travel advisory before.

The illness is a "worldwide health threat," said Dr. Gro Harlem Brundtland, WHO's director general. "The world needs to work together to find its cause, cure the sick, and stop its spread."

Outbreaks of the disease have been reported in southern China, Hong Kong and Singapore. Unconfirmed new cases have been reported in Vietnam and Taiwan.

A team of epidemiologists from the U.S. Centers for Disease Control and Prevention arrived in Hanoi, Vietnam on Saturday and gathered samples from people who may be infected. The samples were immediately sent to the agency's laboratories in Atlanta for tests.

The Hanoi outbreak started after an American businessman traveling from Shanghai via Hong Kong apparently infected up to 30 hospital workers, five of them listed in critical condition. The unidentified U.S. citizen was evacuated and died in Hong Kong.

"What is very important is infection control, which needs to be put in place," said Pascale Brudon, the World Health Organization's representative in Vietnam. "We need to understand much more about what this disease is and how patients are reacting to different treatment."

In southern China's Guangdong province, an illness has in recent months killed five people and sickened more than 300 with pneumonia. The public health bureau there had no comment Saturday while calls went unanswered at the same agency in the city of Guangzhou.

In Canada, Toronto Public Health officials said a woman died March 5 and her adult son died March 13 after arriving recently from Hong Kong. Four of their relatives have been hospitalized.

The pneumonia might have also emerged in British Columbia, where one person was in intensive care at a Vancouver hospital and another person has recovered, Toronto health officials said.

Health officials have set up a hot line in Toronto for people who fear they have the illness.

AP-ES-03-15-03 1449EST

ap.tbo.com