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: June 9, 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 and Synagis is
a trademark.
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 May 29, 1998:
May 29, 1998
To Our Shareholders:
The past two quarters have been a remarkable period for the Company. During
fourth quarter 1997 and first quarter 1998, MedImmune reported combined
revenues of $113.1 million up from $28.1 million in the corresponding period
last year (see attached 1Q98 earnings release). We achieved combined profits
during this period of $16.5 million compared with a net loss of $25.1 million
in the corresponding period last year. During the same period, we closed
critical strategic alliances with Abbott Laboratories, SmithKline Beecham and
Boehringer Ingelheim to help commercialize some of our most important
products. We submitted a Biologic License Application (BLA) requesting FDA
marketing clearance for our monoclonal antibody Synagis (palivizumab;
previously identified as MEDI-493) and we raised $66.3 million in net
proceeds from a private placement of common stock. In April, we were chosen
High Technology Firm of the Year in Maryland.
Also during these quarters, important data became available from a number of
our clinical and pre-clinical programs. We'd like to take the remainder of
this letter to summarize these data and provide you with a sense of our near-
term objectives for these programs.
Synagis (palivizumab)
In May, MedImmune presented Synagis clinical data at the annual conference of
the American Pediatric Society and the Society for Pediatric Research (SPR)
in New Orleans. Synagis has been evaluated for its safety and efficacy in
preventing serious respiratory syncytial virus (RSV) disease in high-risk
infants and a Biologic License Application (BLA) submitted by the Company in
December, 1997 is currently under review by the FDA. RSV is the most common
cause of pneumonia and bronchiolitis in infants and children. If cleared for
marketing, Synagis would be the first monoclonal antibody for any infectious
disease and the Company's most promising product opportunity to date.
A portion of the abstract, presented at the SPR by Edward M. Connor, M.D.,
Vice President, Clinical Research at MedImmune, is provided below:
A randomized (2:1) double-blind, placebo-controlled trial (Impact-
RSV) was conducted to determine the efficacy and safety of Synagis
prophylaxis in premature infants with and without bronchopulmonary
dysplasia (BPD). Between November 15, 1996 and December 13, 1996,
1,502 children were randomized at 139 centers in the United States,
Canada and the United Kingdom. Children received monthly
intramuscular injections of 15 mg/kg of Synagis or placebo during
the RSV season (through April, 1997). Characteristics of groups
were balanced at entry; 99 percent completed the protocol, 93
percent received all 5 injections. Synagis prophylaxis was
associated with a 55 percent reduction in RSV hospitalization
(p<0.001). The direction of effect was consistent across
countries, through the respiratory season, and in subgroups by
gender, age, weight and infants with BPD (39 percent reduction,
p=0.038) and without BPD (78 percent reduction, p<0.001). No
significant differences were found in study drug-related adverse
events (AEs); 10.0 percent placebo versus 10.9 percent Synagis.
Related hepatic (liver) and renal (kidney) AEs were reported in 1
percent of each group. Site of injection reactions were uncommon
(1.8 percent placebo versus 2.7 percent Synagis). Permanent
discontinuation of study drug due to related AE was rare (0.3
percent). Fatalities were balanced: 1.0 percent placebo versus 0.4
percent Synagis.
We believe our most important near-term objective is to work effectively with
the FDA during the review process of Synagis. MedImmune has worked
diligently to answer all review questions and to provide the FDA with
thorough presentations of data, including data from our manufacturing
facilities. To date, the Company and our contract manufacturer, Boehringer
Ingelheim (BI), have completed and characterized three consistency lots of
Synagis and look forward to submitting a supplement to the BLA for production
of Synagis at the BI facility.
Urinary Tract Infection Vaccine
In April, 1997, the Company presented data in the journal Science which
described the successful results of the Company's urinary tract infection
(UTI) vaccine in mice. Since then, the Company has further characterized the
most promising vaccine candidates and has completed a vaccination study in
monkeys. The model developed for monkeys is thought to more closely resemble
what naturally occurs during human bladder infections and therefore serves as
a final check for the Company's vaccine strategy before beginning the
development process.
The results of the monkey vaccination study were very encouraging. All
animals immunized with our "FimH" vaccine developed high levels of antibodies
against the FimH protein which is normally used by bacteria to bind to
bladder cells. It was shown that this antibody could block the binding of
infection-causing bacteria to the surface of bladder cells in vitro. When
the monkeys' bladders were challenged with 100
million bacteria, only one animal in the group developed a mild bladder
infection which was cleared at four days. In contrast, all of the monkeys
who received a placebo vaccination experienced bladder infection, the
majority of which cleared naturally within a week:
Infected Animals
Day 2 Day 4 Day 7
Placebo 4/4 3/4 1/4
Vaccine 1/4 0/4 0/4
We believe these data combined with the more extensive mouse studies support
the concepts behind our UTI vaccine program. We intend to move forward with
pre-clinical development of a defined UTI vaccine candidate on which we hope
to begin clinical testing during 1999.
HPV Vaccine and BTI-322 in Graft-vs.-Host-Disease
During the quarter, data became available from the Phase 1 clinical trial of
our human papillomavirus (HPV) vaccine, MEDI-501. HPVs cause genital warts
and cervical cancer. A successful vaccine to prevent HPV could prevent the
second leading cause of cancer deaths in women. The results of our first
trial of MEDI-501 are encouraging - the vaccine was safe and generally well-
tolerated and all recipients developed HPV antibodies. Additionally, the
antibodies could neutralize HPV in vitro. These data provide the Company the
rationale to move its program forward.
During the quarter, results also became available from a clinical trial using
BTI-322 to treat graft-versus-host disease (GvHD) in bone marrow recipients.
GvHD is a frequent and often fatal outcome of bone marrow transplantation
currently treatable only by steroids. BTI-322 is a murine monoclonal
antibody licensed to MedImmune by BioTransplant Incorporated which has shown
potential to prevent and treat tissue graft rejection in several transplant
settings. In a Phase 1 clinical study at 6 hospitals, BTI-322 was given for
10 days to 20 patients with moderate to severe GvHD resistant to
corticosteroid treatment. GvHD grade measured on a scale of 1 (mild) to 4
(severe) was reduced from 2.95 to 1.80 (p=0.0005) in all patients and from
2.82 to 0.73 (p<0.00001) in the 14 patients who responded to therapy. When
therapy was stopped after 10 days, most of the patients relapsed. BTI-322
was considered generally well-tolerated in these patients. We are currently
enrolling patients into a clinical trial to evaluate MEDI-507, a humanized
form of BTI-322, with an extended dosing regimen to see if we can repeat and
extend the previous BTI-322 results. Data from this trial should be
available by year-end.
Conclusion
Our key objectives during 1998 include completing the review of Synagis by
the FDA, submitting with our partner Abbott Laboratories regulatory
applications of Synagis in Europe and Canada, and successfully launching
Synagis in the United States, if and when cleared for marketing by the FDA.
Additionally, we expect to gain further knowledge about our products in the
pipeline as they progress through clinical trials. We hope you share our
optimism and excitement as we advance through the year. As always, we thank
you for your continued support and look forward to keeping you apprised of
our progress in the months ahead.
/s/ David M. Mott /s/ Wayne T. Hockmeyer
David M. Mott 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.
(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) June 10, 1998
