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: December 15, 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 December 11, 1997:
MEDIMMUNE AND SMITHKLINE BEECHAM FORM WORLDWIDE HUMAN PAPILLOMAVIRUS VACCINE
ALLIANCE
Gaithersburg, MD, and Philadelphia, PA, December 11, 1997 -- MedImmune, Inc.
(Nasdaq:MEDI) and SmithKline Beecham ("SB") (NYSE:SBH) today announced that
they have entered into a strategic alliance to develop and commercialize
human papillomavirus (HPV) vaccines for prevention of cervical cancer and
genital warts. In exchange for exclusive worldwide rights to MedImmune's HPV
vaccine technology, SB has agreed to provide MedImmune with an up-front
payment, future funding and potential developmental and sales milestones
which together could total over $85 million, as well as royalties on any
product sales. 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 in 1998.
"As one of the most successful vaccine companies worldwide, SmithKline
Beecham is an excellent partner for development and commercialization of our
HPV vaccine," commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief
Executive Officer of MedImmune. "HPV is one of the most important medical
problems and one of the most significant commercial opportunities being
targeted in the vaccine field today. We believe that the alliance between
SmithKline Beecham and MedImmune solidifies a leadership position for our
companies in the HPV field and enhances our opportunity together to
successfully develop vaccines against cervical cancer and genital warts."
Under the terms of the agreement, the companies will collaborate on research
and development activities. MedImmune will conduct Phase 1 and Phase 2
clinical trials and manufacture clinical material for those studies. SB is
responsible for the final development of the product, regulatory,
manufacturing, and marketing. Consummation of the transactions contemplated
by the agreement is subject to expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act.
"MedImmune's leadership position in virus-like particle technology for HPV
strengthens SB Biological's vaccine development program for the prevention
and treatment of HPV and complements SB Biological's unique vaccine adjuvant
expertise," said Jean Stephenne, Senior Vice President of SB Biologicals, the
vaccines division of SmithKline Beecham. "By working together we can
accelerate our efforts and increase our chances to successfully develop
vaccines against HPV."
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's first HPV vaccine candidate, MEDI-501, is currently in a Phase 1
clinical trial to evaluate safety, tolerance and immunogenicity. MedImmune's
strategy for vaccine development relies on a virus-like particle (VLP)
technology for producing a structurally identical, non-infectious form of the
virus in vitro. The potential effectiveness of a VLP vaccine candidate has
been demonstrated utilizing an animal model for papillomavirus infection.
MedImmune expects to begin Phase 1 studies with MEDI-504 and MEDI-503, its
HPV-18 and HPV-16 vaccine candidates in 1998. Following Phase 1 studies, the
components will be combined into multi-valent vaccines for Phase 2 and Phase
3 clinical trials.
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.
SmithKline Beecham Biologicals is located in Rixensart, Belgium, and is the
center of all SB's activities in the field of vaccine research, development
and production. SB Biologicals employs over 500 research scientists who are
devoted to discovering and developing cost-effective and more convenient
combination vaccine products to prevent infections which cause serious
medical problems worldwide. SB Biologicals produces well over 750 million
doses of vaccines per year. Every second, 25 doses of SB Biologicals'
vaccines are distributed around the world. SmithKline Beecham, one of the
world's leading healthcare companies, discovers, develops, manufactures and
markets human pharmaceuticals, health-related consumer products and clinical
laboratory testing services.
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 Companies' 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
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.
(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) December 15, 1997
