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: November 5, 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 Letter
to Shareholders dated August 29, 1997:
August 29, 1997
To Our Shareholders:
The last few months have been a truly exciting time for MedImmune. During
the second quarter, we concluded a Phase 3 clinical trial of MEDI-493
(palivizumab), our new monoclonal antibody product for prevention of
respiratory syncytial virus (RSV) disease. In July, all the months of hard
work appear to have paid off with the announcement that MEDI-493
significantly reduced the rate of RSV hospitalization in the patients
studied. We plan to file a Biologic License Application (BLA) by the end
of the year with the United States Food and Drug Administration (FDA)
requesting licensure of the product. We would like to take this
opportunity to share with you the history of MEDI-493 and our future plans
for the product. We hope the smooth progress to date of MEDI-493
development gives you a sense of the broad capabilities we've established
in the areas of applied research, manufacturing scale-up and clinical trial
execution.
RSV DISEASE
RSV, discovered in 1956, has been shown in many studies to be the most
common cause of serious lower respiratory tract disease (e.g., pneumonia
and bronchiolitis) in infants and small children. In otherwise healthy
children, an RSV infection can be mild and may often be mistaken for a
chest cold. In certain high-risk children, however, RSV infection can
quickly lead to breathing difficulties which can result in hospitalization,
mechanical ventilation and sometimes death. RSV causes an estimated 91,000
hospitalizations and 4,500 deaths in the United States each year.
Outbreaks of RSV infection around the world occur at various times every
year. In the Northern hemisphere, RSV infections tend to occur most often
from November through April. Most children become infected with RSV by two
to three years of age confirming its highly contagious nature and infection
can occur more than once in the same individual during the same RSV season.
RSV exacts a great cost in terms of infant illness and utilization of
health care resources. One study showed that hospitalization of an infant
for RSV disease costs over $70,000 for 15 days of treatment. In addition
to direct hospital costs, the economic burden of RSV also includes costs
associated with follow-up care, the management of long-term effects and
time lost from work by parents and other caregivers. Prematurity is one of
the greatest risk factors for severe RSV disease. Other major risk factors
in infants include a lung condition called bronchopulmonary dysplasia (BPD)
and congenital heart disease (CHD). Each year in the United States alone,
there are approximately 300,000 children at highest risk for developing
severe RSV disease, including approximately 280,000 infants born at 35
weeks or less gestation.
MedImmune began its commitment to RSV disease in 1989 when early research
results suggested that antibodies might be useful for preventing this
severe disease in the high-risk populations. The Company developed two
strategies to exploit these initial observations. One was focused on the
development of a polyclonal antibody preparation to neutralize RSV. This
effort, done in partnership with academic and public health collaborators,
resulted in a product called RespiGam (Respiratory Syncytial Virus Immune
Globulin Intravenous (Human)) which was licensed by the FDA in 1996 (please
see full prescribing information). RespiGam is manufactured by
Massachusetts Biologic Laboratories and sold by MedImmune. It is the first
product demonstrated to be safe and effective in reducing the incidence of
RSV hospitalization and the severity of RSV disease in these high risk
infants. The Company's second strategy was focused on the identification
of a potent monoclonal antibody which, if successfully developed, might be
safer, more efficacious and easier to administer than RespiGam.
MEDI-493: THE SECOND GENERATION
The development of MEDI-493 is testament to the hard work and dedication of
many individuals at MedImmune as well as our collaborators. Early in 1989,
our research team set about trying to identify and develop RSV monoclonal
antibodies (MAbs) that would have the ability to neutralize RSV. MedImmune
researchers believed a MAb would provide a much more potent way to deliver
RSV anti-viral activity compared with a polyclonal antibody preparation
such as RespiGam. Their research efforts included a worldwide survey of
available RSV MAbs including several murine MAbs from the National
Institutes of Health and the Centers for Disease Control and Prevention.
The scientists narrowed their search to those RSV MAbs that had excellent
neutralizing activity in vitro and in vivo and bound to sites on the virus
that did not vary. Of the hundreds of RSV MAbs available to the Company,
only two passed our screen. By 1991, MedImmune research scientists began
humanizing these RSV MAbs by replacing non-critical murine segments with
human sequences to reduce the risk of causing an immune reaction to the
antibody itself when given to people. Moreover, the humanization process
actually improved the ability of one of these antibodies to neutralize RSV.
This antibody, later named MEDI-493, was found to be 50 to 100 times more
potent on a weight basis than RespiGam. It also neutralized all strains of
RSV tested.
Over the next three years, progress was rapid. The development team
improved small-scale production levels by five-fold, optimized the process
and produced multiple consecutive batches of MEDI-493 with exceptionally
high yield and purity, the regulatory staff established clear communication
with the FDA to support human clinical trial activities, and the clinical
research group executed a massive clinical program including 13 trials in 8
countries in over 1,800 subjects. The rapid pace of this development
effort could not have been successful without a deep understanding of the
RSV field as well as the full dedication and many long hours committed by
all those involved.
The most recent clinical trial, IMpact-RSV, was a Phase 3, double-blind,
placebo-controlled trial conducted at 139 clinical centers in the United
States, Canada and the United Kingdom in 1,502 high-risk infants. Patients
received a dose of either 15 mg/kg MEDI-493 (n = 1002) or placebo (n = 500)
by intramuscular injection each month for up to five doses during the RSV
season, November 1996 through April 1997. In July 1997, MedImmune
announced the positive preliminary results of the IMpact-RSV clinical
trial. Initial analysis of results showed that MEDI-493 reduced the
incidence of RSV-associated hospitalizations by 55% (p=0.00004; Fisher's
exact test). In addition, certain of the secondary endpoints also reached
statistical significance, including reduced RSV hospital days, RSV ICU
admissions and RSV hospital days with increased supplemental oxygen. The
safety profile was similar between the MEDI-493 and placebo groups.
MEDI-493: FUTURE PLANS
Near year end, the Company plans to submit a Biologic License Application
(BLA) to the FDA requesting licensure of MEDI-493. We expect that
submission to include over 15,000 pages of clinical and manufacturing
information. We also plan to submit regulatory applications to Canadian
and European authorities in 1998. Data are subject to full review by
regulatory authorities which can take at least 12 months.
Commercialization is, of course, subject to approval by regulatory
authorities and there can be no assurance such approval will be obtained.
As part of the initial BLA, the manufacturing staff is now working to
produce multiple lots of MEDI-493 in our expanded Gaithersburg
Manufacturing and Development Facility (GMDF). These are produced to show
consistency at a larger scale. We also expect mechanical completion of our
Frederick Manufacturing Center (FMC) in the fourth quarter and the
beginning of validation in 1998. We believe we'll need to supplement our
own manufacturing capacity to meet the worldwide needs for MEDI-493 and are
currently in discussions with a contract manufacturer to provide that
additional capacity.
While MEDI-493 clinical and manufacturing data have not yet been submitted
or reviewed by the FDA, we are moving forward with certain additional
activities in advance of regulatory action. The Company is conducting
extensive market research to assess the potential usage profile of MEDI-
493. The Company has, for the past year, been carefully assessing its best
strategy for international commercialization. MedImmune expects to select
a partner to commercialize MEDI-493 in markets outside of North America and
plans to market MEDI-493 in the United States with our own sales and
marketing team. We believe the market experience already gained with
RespiGam in the United States provides a strong foundation to apply to the
launch of MEDI-493.
CONCLUSION
In this letter, we have tried to share with you a brief history of the
exceptional efforts of many individuals in the development of MEDI-493.
This product is one of our most exciting near-term opportunities which we
believe, if licensed by regulatory authorities, will help take MedImmune to
a new level of success. In lieu of detailing all of the other activities
of MedImmune, we can say in summary that progress is being made in all
areas of the Company's operations. The Company announced approval of
CytoGam and RespiGam in Canada supporting our strategy to expand to markets
outside the United States. The research, development and clinical research
teams continue to make progress in identifying new product candidates and
moving existing candidates forward in human clinical evaluation. As always,
we thank you for your continued support and hope that you share our
optimism and enthusiasm for the future.
/s/David M. Mott /s/Wayne T. Hockmeyer, Ph.D.
President and Chief Operating Chairman and Chief Executive
Officer Officer
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 United States
Securities and Exchange Commission. Successful development and
commercialization of any of the Company's product candidates will require
thorough clinical evaluation and will be subject to regulatory approval
from authorities such as the FDA in the United States. There can be no
assurance that such approvals will be obtained.
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) November 5, 1997
