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: February 6, 1998
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 offices) (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.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following press
release dated February 9, 1998:
MEDIMMUNE EXPANDS INTERNATIONAL COMMERCIALIZATION OF CYTOGAM
Gaithersburg, MD, February 9, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced it has been granted marketing authorization for CytoGam
(Cytomegalovirus Immune Globulin Intravenous (Human)) from the Secretary of
Health in Mexico and the Drug Institute Bureau of Drug and Medical Materials
Registration in Poland. The Company also announced that it has signed an
exclusive agreement with Genesis Bio-Pharmaceuticals, Inc. for national
distribution of CytoGam in Canada. In August 1997 MedImmune announced that
it received marketing approval for CytoGam from Canadian authorities.
"We have made significant progress in breaking new ground with CytoGam in
international markets," commented Eric Richman, Director, International
Commercialization at MedImmune. "During 1997, international sales increased
six fold to $1.8 million from $0.3 million in 1996. We will continue to
expand our global commercialization efforts in order to provide important
products like CytoGam to transplant patients worldwide."
MedImmune will market CytoGam in Poland and Mexico for the attenuation of
primary cytomegalovirus (CMV) disease associated with kidney transplantation.
The Company has filed marketing applications and is awaiting clearance in
several countries including, Hong Kong, South Korea, Argentina, Hungary and
France. Additionally, MedImmune has been working with the French authorities
to file a summary application seeking "Authorisations Temporaires
d'Utilisation" in order to provide CytoGam on a named patient basis.
"Our agreement with Genesis Bio-Pharmaceuticals provides us with immediate
access to the Canadian market," added Mr. Richman. "They have extensive
experience with the Canadian Red Cross and have successfully launched several
plasma-derived products in Canada over the last 15 years." Genesis Bio-
Pharmaceuticals is an organization that specializes in the marketing, sales
and distribution of plasma derived products and vaccines.
CytoGam is an intravenous immune globulin enriched in antibodies against CMV
and is marketed by MedImmune in the United States for the attenuation of
primary CMV disease in donor-positive / recipient-negative kidney transplant
patients (please see full prescribing information). The Company currently
sells CytoGam through distributors in certain Eastern European countries and
intends to file for marketing approval in other European and Latin American
countries during 1998.
CMV is the most important cause of infection occurring after transplantation
and contributes to significant morbidity and mortality. In transplant
patients, CMV can cause severe pneumonia, increased bacterial and fungal
infections and other organ complications related to CMV tissue invasive
disease which, if not successfully treated, can lead to organ failure. CMV
has also been associated with an increased risk of rejection of the
transplanted organ.
MedImmune, Inc. is a biotechnology company focused on developing and
marketing products for the prevention and treatment of infectious diseases
and for use in transplantation medicine. The Company currently markets two
products through its hospital-based sales force and has five new product
candidates in clinical trials. CytoGam is manufactured by Massachusetts
Biologic Laboratories. MedImmune is located in Gaithersburg, MD.
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 the Company's filings with the U.S. Securities and
Exchange Commission. MedImmune cautions that sale of CytoGam outside of the
U.S. will require marketing clearance by regulatory authorities; there can be
no assurances that such clearance will be obtained.
(REGISTRANT) MEDIMMUNE, INC.
BY (SIGNATURE) /s/ David M. Mott
(NAME AND TITLE) David M. Mott, President and Chief Operating Officer
(Principal financial and accounting officer)
(DATE) February 11, 1998
