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 3, 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 1, 1997:
MEDIMMUNE AND ABBOTT LABORATORIES SIGN GLOBAL ALLIANCE TO MARKET MEDI-493
Gaithersburg, MD and Abbott Park, IL, December 1, 1997 -- MedImmune, Inc.
(Nasdaq:MEDI) and Abbott Laboratories (NYSE:ABT) today announced that they
have formed an exclusive worldwide marketing alliance for MEDI-493
(palivizumab), a humanized respiratory syncytial virus (RSV) monoclonal
antibody being developed for the prevention of serious RSV disease in infants
and children. Two separate agreements were signed, a distribution agreement
outside the U.S. and a threshold-based co-promotion agreement within the U.S.
Outside the U.S., Abbott's international division will have the exclusive
right to market and distribute MEDI-493. MedImmune will manufacture and sell
MEDI-493 to Abbott. MedImmune has received a $15 million payment, would
receive an additional $30 million if and when MEDI-493 receives U.S. and
European marketing approvals, and would receive an additional $15 million
upon the achievement of certain sales levels by Abbott.
Within the U.S., Abbott's Ross Products division will co-promote MEDI-493
with MedImmune. MedImmune will be credited with all U.S. sales and Abbott
will receive a commission on sales above pre-determined thresholds. Each
Company is responsible for its own selling expenses.
"Abbott has a long-established commitment to pediatric health care," said
Duane L. Burnham, Chairman and Chief Executive Officer of Abbott
Laboratories. "We believe MEDI-493 has the potential to positively impact the
lives of many infants and children worldwide and we are pleased to have the
opportunity to add it to our portfolio of novel pediatric and infectious
disease products."
"Abbott is one of the most respected health care companies worldwide,"
commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer of
MedImmune. "We believe Abbott's leadership within the pediatric marketplace
together with its global reach will accelerate and broaden our ability to
deliver MEDI-493 to the children who could benefit." Dr. Hockmeyer added
that, "This alliance represents a great synergy of common commitment and
interest in pediatric healthcare."
RSV is the most common cause of lower respiratory infections in infants and
children worldwide. Healthy children and individuals with adequate immune
systems often acquire a benign chest cold when infected with RSV. In
contrast, premature infants and children with bronchopulmonary dysplasia
(BPD) are at increased risk for acquiring severe RSV disease (pneumonia and
bronchiolitis), often requiring hospitalization. In the U.S. alone, over
90,000 children are hospitalized and 4,500 die from RSV disease annually.
There are approximately 325,000 infants at risk of acquiring severe RSV
disease in the U.S. and the Companies believe that the number of infants at
risk outside the U.S. is at least as large. MEDI-493 is a humanized
monoclonal antibody that has been evaluated in a Phase 3 double-blind,
placebo-controlled clinical trial for its ability to prevent RSV disease in
high-risk infants.
"The partnership we have formed with Abbott represents a new model in the
biotechnology industry to commercialize products," commented David M. Mott,
President and Chief Operating Officer of MedImmune. "Access to the Ross
Products division pediatric sales force provides MedImmune with a cost-
effective way to reach the office-based pediatrician. Clearly, Abbott's
successful track record, their extensive customer base and their strong
presence in pediatrics will complement our own sales efforts in the U.S."
"Selecting Abbott as our distributor outside the U.S. gives MedImmune access
to an experienced and capable international sales and marketing organization
which will help accelerate the commercialization of MEDI-493 globally," added
Mr. Mott.
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.
Abbott Laboratories is a global, diversified health care company devoted to
the discovery, development, manufacture and marketing of pharmaceutical,
diagnostic, nutritional and hospital products. The company employs 54,000
people and markets its products in more than 130 countries. In 1996, the
company's sales and net earnings were $11.0 billion and $1.9 billion,
respectively, with earnings per share of $2.41.
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. Commercialization of MEDI-493 will require prior
approval from regulatory authorities. There can be no assurance that such
approvals will be obtained.
Abbott's news releases and other information are available on the Company's
web site at http://www.abbott.com.
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 3, 1997
