GAITHERSBURG, Md., May 21 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that the Federal Trade Commission has
terminated the review period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 for the company's reacquisition of FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal) and related technology from Wyeth
(NYSE: WYE). MedImmune expects to close the termination of the collaboration
in the near future.
As announced on April 26, 2004, MedImmune and Wyeth agreed that MedImmune
would reacquire the rights to the FluMist franchise and all related
technology, including the next generation, liquid formulation known as CAIV-T
(Cold Adapted Influenza Vaccine-Trivalent) now in Phase 3 development.
David M. Mott, MedImmune's president and chief executive officer, stated:
"Now that governmental clearance has been granted, we can finalize the
termination of our collaboration for FluMist with Wyeth and assume full
responsibility for the commercialization of FluMist and the development of
CAIV-T. Over the next three years we plan to educate physicians and
healthcare professionals, particularly pediatricians, on the benefits of
influenza vaccinations, as well as work to develop CAIV-T into a superior
vaccine for children."
CAIV-T is an investigational intranasal, cold-adapted trivalent influenza
vaccine. It is the next generation, refrigerator-stable formulation of
FluMist, which is a frozen, live attenuated cold-adapted trivalent influenza
vaccine. To date, the safety, tolerability and efficacy of CAIV-T has been
studied in both healthy and at-risk populations between the ages of 6 weeks
and 98 years. Some of these data were presented in October 2003 at the Fifth
Annual Options for the Control of Influenza Conference in Okinawa, Japan as
well as at the Pediatric Academic Societies' annual meeting earlier this
FluMist is the first live, attenuated influenza vaccine indicated for
active immunization for the prevention of disease caused by influenza A and B
viruses in healthy children and adolescents, 5 to 17 years of age, and healthy
adults, 18 to 49 years of age.
There are risks associated with all vaccines, including FluMist. FluMist
does not protect 100 percent of individuals vaccinated. FluMist is not
indicated for immunization of individuals less than 5 years of age, or 50
years of age and older.
FluMist is contraindicated in persons with hypersensitivity to any
component of the vaccine, including eggs; in children and adolescents
receiving aspirin therapy or aspirin-containing therapy; in individuals with a
history of Guillain-Barre syndrome; and in individuals with known or suspected
immune deficiency. The safety and efficacy of FluMist have not been
established in pregnant women or for patients with chronic underlying medical
conditions, including asthma or reactive airways disease; the vaccine should
not be administered to these patients. In placebo-controlled clinical trials,
the most common solicited adverse events in healthy children (n=214) included
runny nose/nasal congestion, cough, irritability, headache, decreased
activity, sore throat, fever (oral temperature>100 F), muscle aches, chills,
and vomiting. The most common adverse events in healthy adults (n=2,548)
included runny nose, headache, sore throat, tiredness/weakness, muscle aches,
cough, and chills. See Prescribing Information for indications and usage,
dosage and administration, and safety information.
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 four
products, Synagis(R) (palivizumab), Ethyol(R) (amifostine), FluMist(TM)
(Influenza Virus Vaccine Live, Intranasal), and CytoGam(R) (cytomegalovirus
immune globulin intravenous (human)), and has additional products in clinical
testing. MedImmune employs approximately 1,800 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 its products, visit the company's
website at www.medimmune.com.
DISCLOSURE NOTICE: The information contained in this document is as of
May 20, 2004 and will not be updated as a result of new information or future
events. This document contains forward-looking statements regarding
MedImmune's future financial performance and business prospects. Those
statements involve substantial risks and uncertainties. You can identify
those statements by the fact that they contain words such as "anticipate,"
"believe," "estimate," "expect," "intend," "project" or other terms of similar
meaning. Those statements reflect management's current beliefs and are based
on numerous assumptions, which MedImmune cannot control and which may not
develop as MedImmune expects. Consequently, actual results may differ
materially from those projected in the forward-looking statements. Among the
factors that could cause actual results to differ materially are: seasonal
demand for and continued supply of our principal product, Synagis; whether
FluMist receives clearance by the Food and Drug Administration and, if it
does, whether it will be successfully launched at a favorable price;
availability of competitive products in the market; availability of third-
party reimbursement for the cost of our products; effectiveness and safety of
our products; exposure to product liability, intellectual property or other
types of litigation; foreign currency exchange rate fluctuations; changes in
generally accepted accounting principles; growth in costs and expenses; the
impact of acquisitions, divestitures and other unusual items; and the risks,
uncertainties and other matters discussed in MedImmune's Annual Report on Form
10-K for the year ended December 31, 2003, its quarterly reports on Form 10-Q
and its current reports on Form 8-K filed with the U.S. Securities and
Exchange Commission. MedImmune cautions that RSV disease occurs primarily
during the winter months; MedImmune believes its operating results will
reflect that seasonality for the foreseeable future. MedImmune is also
developing several products (including FluMist) 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.
SOURCE MedImmune, Inc.
CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358, or John Filler, +1-301-398-4086, all of MedImmune, Inc.
Web site: http://www.medimmune.com