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: August 7, 1997
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 August 6, 1997:
MEDIMMUNE RECEIVES MARKETING APPROVAL FOR CYTOGAM IN CANADA
- Launch Planned for September -
Gaithersburg, MD, August 6, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced it has received a notice of compliance for CytoGam
(Cytomegalovirus Immune Globulin Intravenous (Human)) from the Therapeutic
Products Directorate of the Health Protection Branch (HPB) of Health Canada.
The notice, granted for the attenuation of primary cytomegalovirus (CMV)
disease associated with kidney transplantation, allows MedImmune to market
CytoGam for that indication in Canada. CytoGam is currently marketed by
MedImmune in the United States (please see full prescribing information).
"With Canadian approval, MedImmune continues to carry out its strategy of
expanding the use of CytoGam into markets outside of the United States,"
commented David M. Mott, President and Chief Operating Officer. MedImmune
plans to market CytoGam through a national distributor in Canada and expects
to launch the product to the Canadian Transplantation Society during the
66th Annual Meeting of the Royal College of Physicians and Surgeons of
Canada on September 25 through 28, 1997 in Vancouver, British Columbia.
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.
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. 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.
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 six 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. Launch of CytoGam in Canada is subject to certain
regulatory requirements and reimbursement approvals.
SIGNATURE
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 thereunto duly authorized.
MEDIMMUNE, INC.
Registrant)
Date: August 7, 1997 /s/ David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
