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: January 19, 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 January 16, 1998:
MEDIMMUNE FINALIZES VACCINE AGREEMENT WITH SMITHKLINE BEECHAM
Gaithersburg, MD, January 16, 1998 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced that it has finalized its agreement with SmithKline Beecham (SB)
(NYSE:SBH) to develop and commercialize human papillomavirus (HPV) vaccines
for prevention of cervical cancer and genital warts. The companies
previously announced, in a press release dated December 11, 1997, that
closing of the agreement was subject to expiration of the waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act, which has occurred.
Under the terms of the agreement, SB receives exclusive worldwide rights to
MedImmune's HPV vaccine technology in exchange for an up-front payment,
future funding and potential developmental and sales milestones which
together could total over $85 million. In addition, MedImmune will receive
royalties on any product sales should a vaccine be successfully
commercialized.
Currently, MedImmune is conducting a Phase 1 clinical trial with its first
HPV vaccine candidate, HPV-11. MedImmune expects to begin clinical
evaluation of HPV-18 and HPV-16 vaccine candidates this year. Following
Phase 1 studies, the components will be combined into multi-valent vaccines
for Phase 2 and Phase 3 clinical trials. SB is responsible for the final
development of the product, regulatory, manufacturing, and marketing.
HPVs are responsible for the development of genital warts and cervical
cancer. There are over 75 different types of HPV associated with a variety of
clinical disorders ranging from benign lesions to potentially lethal cancers.
Four types of HPV cause the majority of genital warts and cervical cancer
cases: HPV-6, HPV-11, HPV-16 and HPV-18. There are currently no vaccines to
prevent these common sexually transmitted diseases that affect 24 to 40
million men and women in the United States.
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.
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. Commercialization of an HPV vaccine will require prior
approval from regulatory authorities, including the Food and Drug
Administration in the U.S. There can be no assurance that such approvals
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) January 19, 1998
