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: May 19, 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 May 16, 1997:
May 16, 1997
To Our Shareholders:
The successful launch of RespiGam (Respiratory Syncytial Virus Immune
Globulin Intravenous (Human)) during 1996 further expanded MedImmune=s
commercial base. As shown in the accompanying earnings press release,
product sales increased 53 percent in first quarter 1997 compared to first
quarter 1996. With two products on the market, a strong cash position and
a fully integrated business, we approached the year of 1997 with great
enthusiasm.
While our Sales and Marketing team has focused on bringing RespiGam to
market and increasing sales of CytoGam (Cytomegalovirus Immune Globulin
Intravenous (Human)), the Research and Development group has made important
progress building our pipeline for the future. We currently have six
product candidates in clinical trials and several discovery programs
ongoing. In this letter, we would like to focus on some of the exciting
developments in the clinical and discovery areas at MedImmune.
<TABLE>
<S> <C> <C>
Product Indication Status(1)
- -------------------------------------------------------------------
Infectious Disease Products
- ---------------------------
RespiGam(2) Prevention of serious RSV disease in Marketed
RSV-IGIV infants with prematurity or lung Phase 3 (Baxter
disease sponsored)
MEDI-493 RSV Prevention of RSV disease in infants Phase 3
Monoclonal Treatment of RSV disease Phase 2
Antibody
MEDI-491 B19 Prevention of B19 parvovirus Phase 1
Parvovirus infection
Vaccine
HPV Vaccine Prevention of genital warts Phase 1
Prevention of cervical cancer Pre-clinical
development
Second Prevention of Lyme disease Pre-clinical
Generation development
Disease Vaccine
E. coli Vaccine Prevention of urinary tract Pre-clinical
infections development
H. influenzae Prevention of otitis media (middle Research
Vaccine ear
infections)
S. aureus Prevention of staphylococcus Research
Vaccine/ infections
Immunotherapy
S. pneumoniae Prevention and treatment of Research
Vaccine streptococcus pneumoniae infection
RSV Vaccine(3) Prevention of RSV disease Phase 2 (AHP
sponsored)
Transplantation Products
- ------------------------
CytoGam Attenuation of primary CMV disease in Marketed
kidney transplant patients
Prevention of CMV disease in all PLA amendment
solid organ transplant patients submitted
MEDI-500 (T10B9) Prevention of GvHD in bone marrow Phase 3 (NHLBI
Monoclonal transplant patients sponsored)
Antibody Treatment of acute kidney Phase 1/2
rejection
BTI-322 Prevention of kidney rejection Phase 1/2
Monoclonal Treatment of GvHD in bone marrow Phase 2
Antibody transplant patients
Treatment of acute kidney rejection Phase 1
MEDI-507 Prevention of kidney rejection Phase 1
Monoclonal Treatment of autoimmune diseases Pre-clinical
Antibody development
</TABLE>
(1) "Phase 1" and "Phase 2" clinical trials generally involve
administration of a product to a limited number of patients to
evaluate safety, dosage and, to some extent, efficacy. "Phase 3"
clinical trials generally examine the efficacy and safety of a product
in an expanded patient population at multiple clinical sites.
(2) AHP co-promotes RespiGam in the United States. Baxter holds a license
to commercialize RespiGam outside North America, and the Company would
receive a royalty on any sales by Baxter.
(3) This product is being developed by AHP. The Company is entitled to a
royalty on any sales, if and when licensed for marketing by the FDA.
Clinical Progress
MEDI-493 is MedImmune=s second generation product for the prevention of
respiratory syncytial disease (RSV) in high-risk infants. RSV is the
leading cause of pneumonia and bronchiolitis in infants and small children
and results in approximately 90,000 hospitalizations and 4,500 deaths each
year. Currently, MEDI-493 is being evaluated in a Phase 3 clinical trial,
known as AIMpact-RSV@. The trial includes 1,502 infants and is being
conducted at 139 medical centers in the United States, Canada and the
United Kingdom. It is being concluded this month and we expect to announce
results in the third quarter.
MEDI-493, if successfully commercialized, would build on MedImmune=s RSV
sales and marketing presence already established with RespiGam7. MEDI-493
is administered by an intramuscular injection rather than the two to four
hour intravenous infusion required with RespiGam. Consequently, MEDI-493
has the potential to enhance patient care, reduce costs associated with
drug administration and improve convenience for parents, physicians and
nurses. Taken together, the Company believes these benefits may provide
the potential to reach a broader population of children with MEDI-493 than
with RespiGam.
During the first quarter, the Company presented results from Phase 1 and
Phase 1/2 clinical trials, in both adults and children which were conducted
to evaluate the safety and pharmacokinetics of MEDI-493 for the prevention
of serious RSV disease. The table below summarizes the data analyzed to
date as well as clinical trials which are currently in progress. We are
continuing to analyze data from ongoing and recently concluded clinical
trials and will report on those results as they become available.
<TABLE>
MEDI-493 Clinical Development
<S> <C> <C> <C> <C> <C>
PROTOCOL DESIGN PHASE PATIENTS STATUS RESULTS
- -------------------------------------------------------------------------
- --
MAb- Open-Label 1 4 Healthy Complete Well tolerated at
9401a Adult all doses tested
(IV) Volunteers ranging from 1 to 15
mg/kg with no drug
related serious
adverse events;
MAb- Open- 1 12 Healthy Complete No significant
9401b Label, Adult differences in the
(IV) Dose Volunteers safety profile were
Escalation observed
MAb- Open- 1 12 Healthy Complete between different
9401c Label, Adult formulations (liquid
(IV) Dose Volunteers or lyophilized) or
Escalation routes of
CP007 Open-Label 1 4 Healthy Complete administration (IV
(IM) Adult or IM); Half-life
Volunteers data supports
monthly dosing;
CP017 Open- 1 6 Healthy Complete supports 15 mg/kg
(IV) Label, Adult dose
Lyophilized Volunteers
Product
CP005 Double- 1/2 62 High-risk Complete Generally safe and
(IV) Blind, Infants well tolerated; Half-
Placebo- life data supports
Controlled, monthly dosing;
Dose incidence of all
Escalation; respiratory
Prevention hospitalizations
(3/20 - placebo;
5/10, 1/10, 3/22 in
3, 10, 15 mg/kg,
respectively); RSV-
associated
hospitalizations
(2/20 - placebo;
2/10, 0/10, 0/22 in
3, 10, 15 mg/kg,
respectively)
CP011 Open- 1/2 65 High-risk Complete Generally safe and
(IM) Label, Infants well tolerated; Half-
Dose life data supports
Escalation; monthly dosing; data
Prevention supports 15 mg/kg
dose; incidence of
RSV-associated
hospitalizations
(2/11, 0/6, 0/48 in
5, 10, 15 mg/kg,
respectively)
CP012 Open- 1/2 59 High-risk Complete Generally safe and
(IM) Label, Infants well tolerated;
Dose RSV-associated
Escalation; hospitalizations
Prevention (1/10, 0/49 in 5, 15
mg/kg, respectively)
CP018 Double- 3 1,502 High- Closed Trial in progress;
(IM) Blind, risk Infants Completion date
Placebo- 5/15/97; Results
Controlled, unblinded and
Randomized; announced 3Q97
Prevention
IV = Intravenous; IM = Intramuscular
</TABLE>
During and subsequent to the first quarter, two of MedImmune=s product
candidates have advanced into human clinical study. In February 1997, we
began clinical evaluation of the first vaccine intended to prevent human
papillomavirus (HPV) infection. HPV causes cervical cancer in women which
accounts for some 500,000 cases worldwide and 4,800 deaths in the U.S.
annually. Development of an effective HPV vaccine is one of the most
important R&D objectives at MedImmune.
This month, the Company began the first human clinical trial with MEDI-507,
a humanized monoclonal antibody being evaluated for potential application
in transplantation medicine and autoimmune disease. MEDI-507 binds
specifically to a receptor found on T cells and natural killer (NK) cells.
Despite significant improvements in the transplantation arena, life-
threatening complications such as graft-vs-host disease (GvHD) and
rejection remain serious medical problems. MEDI-507 could be an antibody
capable of blocking the actions of cells responsible for these problems
thereby improving the chances for successful transplantation. MEDI-507 may
also be potentially useful in the treatment of autoimmune disorders such as
psoriasis, inflammatory bowel disease and rheumatoid arthritis.
Research and Development Progress
In April 1997, MedImmune scientists and collaborators published results
from important studies on our urinary tract infection (UTI) vaccine
candidate in the journal Science. Results of animal studies demonstrated
the effectiveness of our lead vaccine candidate in preventing infection by
the disease-causing bacteria, E. coli. UTIs are a significant medical
problem which affect over 7 million people annually, particularly women,
and cost a total of over $1 billion each year to treat.
Due to the medical burden created by UTIs, the progress in vaccine
development generated worldwide news coverage. An interview with Dr.
Solomon Langermann, Director of Immunology and Molecular Genetics at
MedImmune and lead author on the publication, appeared on CNN, BBC and
MSNBC. Journalists from newspapers, women=s magazines, and U.S., European
and Canadian news services, reported on the encouraging findings. The
Company is currently conducting vaccination studies in non-human primates
and hopes to move forward into clinical evaluation during 1998.
Conclusion
In addition to the programs outlined above, the Company has ongoing efforts
in place to develop vaccines for other viral and bacterial diseases
including Lyme disease, B19 parvovirus, Streptococcus pneumoniae,
Haemophilus influenzae and Staphylococcus aureus. 1997 will be an exciting
time for MedImmune as our focus turns towards the results of the Phase 3
trial for MEDI-493. As always, we thank you for your continued support and
hope that you share our optimism and enthusiasm for the future.
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 U.S. 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 U.S. 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.
MEDIMMUNE, INC.
Registrant)
Date: May 19, 1997 David M. Mott
President and Chief Operating Officer
(Principal financial and
accounting officer)
