SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: September 2, 1999
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 52-1555759
(State of Incorporation) (I.R.S. Employer
Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive office (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
No Exhibits are being filed with this report
CytoGam and RespiGam are registered trademarks of the Company and Synagis is a
trademark.
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MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated September 1, 1999:
ABBOTT ANNOUNCES APPROVAL OF BREAKTHROUGH PREVENTION
FOR RSV IN EUROPE
- Synagis Now Available In Europe -
Abbott Park, IL and Gaithersburg, MD, September 1, 1999 -- Abbott Laboratories
(NYSE:ABT) and MedImmune, Inc. (Nasdaq:MEDI) today announced the European
Commission granted a marketing authorization for Synagis (palivizumab) for the
prevention of serious lower respiratory tract disease requiring hospitalization
caused by respiratory syncytial virus (RSV) in high-risk infants. Synagis is
indicated for use in infants born prematurely (less than or equal to 35 weeks
gestational age), and infants and children with chronic bronchopulmonary
dysplasia (BPD), a chronic lung disease.
Synagis, the first monoclonal antibody to be licensed in the United States for
any infectious disease, is also the first product to deliver safe and effective
RSV protection with a simple intramuscular (IM) injection. The injection can be
administered in the primary health-care provider's office once a month during
the RSV season -- typically November to April in Europe.
RSV is the most common cause of lower respiratory infections in infants and
children worldwide. In fact, half of all children around the world develop RSV
infections by the age of one year, and by the age of two, virtually all children
have been infected. In high-risk children infected with RSV, 70 percent may
require hospitalization, 25 percent may require mechanical ventilation and some
may die as a result of RSV infection.
"RSV can be a life-threatening disease for premature babies and young children
with BPD," says David Goffredo, Vice President, European Operations, Abbott.
"Synagis has the potential to enhance patient care, reduce costs associated with
prolonged hospital stays and reassure parents that they are taking an important
step to help improve their child's health and well-being."
The U.S. Food and Drug Administration (FDA) approved Synagis for marketing in
June 1998.
RSV Studies
A placebo-controlled, randomized study -- one of the largest studies ever
conducted in premature infants- showed Synagis reduced the risk of
hospitalization due to RSV by 55 percent. Studies were conducted in premature
infants, including those with BPD. The most frequently reported adverse
reactions were fever, nervousness and injection site reaction, however these
rates were similar in the treatment versus placebo groups.
In addition to its success in preventing RSV, Synagis does not interfere with
normal childhood vaccines including the measles-mumps-rubella vaccine and the
varicella virus vaccine.
About RSV
Common symptoms of RSV include a low-grade fever, runny nose and cough. The
cough may be accompanied by wheezing and difficulty in breathing, which can
indicate that the virus has moved to the lower respiratory tract. RSV spreads
easily from person to person via sneezing or coughing, or from hands touching
the nose or eyes and then coming in contact with another person or object. The
chance of spreading the virus within a family is very high; many times,
school-aged children introduce the virus into the family. Despite strict
infection control procedures, hospital nursery units, day care centers, and
other similar institutions are also at high-risk for RSV outbreaks.
"Synagis represents a major breakthrough in RSV prevention," said William
Dempsey, Senior Vice President, International Operations, Abbott Laboratories.
"Abbott believes Synagis will provide high-risk children with even greater
protection against this disease."
"We are pleased with the European Commission's decision to approve Synagis
for marketing in Europe," commented Melvin D. Booth, President and Chief
Operating Officer at MedImmune. "RSV is a worldwide problem, and we, with
our colleagues at Abbott, want to make Synagis globally available."
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In December 1997, Abbott Laboratories and MedImmune, Inc. formed an exclusive
worldwide marketing alliance to commercialize Synagis. Abbott has the exclusive
right to market and distribute Synagis outside the United States. In the U.S.,
where Synagis was approved for marketing in June 1998, MedImmune and Abbott have
an agreement to co-promote the product.
Abbott Laboratories is a global, diversified health care company devoted to the
discovery, development, manufacturing and marketing of pharmaceutical,
diagnostic, nutritional and hospital products. Abbott Laboratories is located in
Abbott Park, Ill. The company employs 56,000 people and markets its products in
more than 130 countries.
MedImmune, Inc., located in Gaithersburg, Md., is a biotechnology company
focused on developing and marketing products that address medical needs in areas
such as infectious disease, transplantation medicine, autoimmune disorders and
cancer. MedImmune markets three products through its hospital-based sales force
and has five new product candidates in clinical trials.
This announcement may contain, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties. 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 both
companies' filings with the U.S. Securities and Exchange Commission.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
MEDIMMUNE,INC.
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(Registrant)
September 2, 1999 /s/ David M. Mott
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David M. Mott, Vice Chairman and
Chief Financial Officer
