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[Moneymaker75]

Others called for head-to-head comparisons to the traditional flu shot.

Panel chairman Dr. Robert S. Daum urged the FDA to require annual monitoring of the vaccine if approved but overall said the additional information submitted since the last panel meeting was convincing.

"A great majority of the things we would like to see done have been addressed, " said Dr. Daum, professor of pediatrics at the University of Chicago Children`s Hospital.

Consumers are expected to flock to the easier-to-use vaccine in favor of the painful needle despite a price tag of at least twice the cost of the $15 for the shot, according to analyst Philip Nadeau of SG Cowen, an investment bank that makes a market in MedImmune securities.

If FDA grants approval, in 2006 Nadeau projects the vaccine will have reached $390 million in sales. Nadeau cut $50 million off of his projection because the panel didn`t recommend the vaccine for older Americans.

Like the shot, FluMist is to be given yearly to prompt the body`s immune system develop weapons to fight off constantly changing strains of the virus. For those unfortunate enough to become infected, fever, headache, body aches, cough, sore throat and congestion usually follows. In severe cases, especially among people who don`t have strong immune systems, more serious illness or death can result. The Centers for Disease Control and Prevention blames the flu for more than 20,000 deaths each year.

MedImmune inherited FluMist when it purchased Aviron Inc. Aviron submitted the FluMist application in 2000. Since then, Aviron and MedImmune have furnished FDA with more than 13,000 pages of additional information to address the agency`s concerns about the product.

MedImmune`s marketing partner Wyeth, a leading vaccine manufacturer, announced last month it will no longer make the flu shot and instead focus on FluMist. Also, CDC now recommends more Americans get an annual flu vaccination.

- Otesa Middleton; 202-862-6654; [e-mail]

[Moneymaker75]

FDA Advisory Committee Recommends Approval for MedImmune`s FluMist(TM) to Prevent Influenza

GAITHERSBURG, Md., and RADNOR, Pa., Dec. 17 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration`s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended that the FDA approve FluMist(TM) (Influenza Virus Vaccine Live, Intranasal) to prevent influenza in healthy children, adolescents and adults ages 5 through 49.

If approved by the FDA, FluMist would be the first and only intranasal influenza vaccine in the United States.

The VRBPAC panel voted in favor of the product`s safety in the 50-to-64- year age group, but indicated that they believed the data set on efficacy in the 50-to-64-year age group was inadequate at this time.

Advisory committees provide the FDA with independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies. Advisory committees consist of individuals who are recognized as experts in their field from many different sectors including medical professionals, scientists and researchers, industry leaders, and consumer representatives and patient representatives. While advisory committee recommendations are valuable, all final decisions related to a regulated product are made by the FDA. There can be no assurance that the FDA will follow the advisory committee`s recommendation.

Dr. Edward M. Connor, MedImmune`s senior vice president, clinical development, said, "We are very pleased with the outcome of today`s VRBPAC meeting and believe that the results move us closer to our goal of bringing FluMist to market by the 2003-2004 flu season. We look forward to continuing to work with the FDA to answer any additional questions that remain in the agency`s review of our application."

A total of 20,228 children, adolescents and adults received 28,979 doses of FluMist in 20 clinical trials structured to evaluate the safety and efficacy of the vaccine to prevent influenza in healthy people. In the trials, the most common adverse event attributable to FluMist was runny nose/nasal congestion.

"FluMist is cutting-edge technology in influenza vaccine delivery in the U.S. aimed at protecting the health of children and adults," says Bernard Poussot, president, Wyeth Pharmaceuticals. "FluMist, with its intranasal administration, may help reduce disease burden on the health care system by increasing influenza vaccination rates."

Influenza is the most common cause of medically attended acute respiratory illness in the U.S. often involving fever, chills, muscle weakness, cough, sore throat, nasal congestion, headache and general malaise. According to the Centers for Disease Control and Prevention and the American Lung Association, 20 to 50 million people are infected annually in the U.S., causing 70 million lost work days(1), 38 million lost school days(2), and 20,000 to 50,000 deaths per year (primarily in the elderly)(3). The annual burden of the disease to society has been estimated at $15 billion.

If and when FluMist is approved for marketing by the FDA, it would be marketed by MedImmune and Wyeth Pharmaceuticals, a division of Wyeth, as part of an ongoing global collaboration agreement.

MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets three products, Synagis(R) (palivizumab), Ethyol(R) (amifostine) and CytoGam(R) (cytomegalovirus immune globulin intravenous (human)), and has 10 products in clinical testing. MedImmune employs approximately 1,600 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on MedImmune and full prescribing information for the company`s marketed products, visit the company`s website at http://www.medimmune.com.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women`s health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world`s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company`s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, including risks and uncertainties surrounding the potential approval, launch and successful acceptance of FluMist in the marketplace. Such statements reflect management`s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the company`s filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.

(1) Adams PF, Hendershot GE, Marano MA. Current estimates from the
National Health Interview Survey, 1996 National Center for Health
Statistics. Vital Health Stat. 10(200) 1999
(2) Adams PF, Hendershot GE, Marano MA. Current estimates from the
National Health Interview Survey, 1996 National Center for Health
Statistics. Vital Health Stat. 10(200) 1999
(3) CDC. ACIP/MMWR. 2002; 51 (no, RR-3):1-31

[Hurricanfighterplane4]

Wieso ist denn der Kurs ausgesetzt?

[kraxlhuber]

Das Problem ist die Altersbeschränkung 5 - 49.

Andererseits war die Begründung für diese
Beschränkung fehlende Studien.

Die Studien kann man ja nachholen während man einstweilen
an die Altersgruppe 5 - 49 verkauft.

kraxl

[jetti]

881477

[puhvogel]

Bei den Senioren ist Medimmune/Aviron auch selber schuld.
500 Partizipanten dieser Altersklasse über 50 von insgesamt 20000 getesteten Personen.
Mein Tip: Ein Plus von 1,5 $, bestimmt aber keine Verdopplung.

[puhvogel]

PS: Ich möchte mich bei allen in der Altersklasse zwischen 50 bis 64 entschuldigen, da ich sie als Senioren bezeichnet habe.

[SteelyDan]

Frage an die Experten:

Heute morgen habe ich noch mal 60 000 OS 640666 nachgetankt , kurz bevor der Handel ausgesetzt wurde.
Heute morgen hat der OS Rechner bei comdirect mir noch eine
Vola von über 70 angezeigt, jetzt sinds gerade noch 50.
WAS SOLL DAS???
Hat die Citibank keine Interesse, ein paar Euros rauszurücken?
Für Tips bin ich dankbar!

Gruß

SD

[puhvogel]

Du hast einen Schein zu weit aus dem Geld gekauft, da kann der Emittent nach Gutdünken die Vola rauf oder runter schrauben.
Das hätte sich erst dann gelohnt , wenn die Aktie adhoc auf 38 $ gesprungen wäre. Das das nicht klappt hätte ich dir vorher sagen können.
Aber selbst bei meinem Schein im Geld sind die auf einer historisch niedrigen Vola, die wieder höher werden muss.

[puhvogel]

Ein wunderschönes Beispiel, ich meine den Montag:

Blau ist die Basis, schwarz der Put aus dem Geld.

[SteelyDan]

@puhvogel

Danke - genau das hatte ich befürchtet

[puhvogel]

Aber nicht alles auf die Citibank schieben, der Markt wusste natürlich auch von dem hohen Risiko. Insofern haben die Wave-Papiere schon ihren Vorteil.
http://finance.yahoo.com/q?s=medi&d=o
Vergleich mal Gewinne der Calls zu den Verlusten der Puts.
Da werden gerade ein paar Shorties gebraten.