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 22, 1996
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 is a registered trademark and
RespiGam is a trademark of the Company.
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained on the following
press releases dated November 12, 20 and 21, 1996 and the Letter to
Shareholders dated November 22, 1996.
MEDIMMUNE PROMOTES WILLIAM I. BRADEN TO VICE PRESIDENT, ENGINEERING,
FACILITIES AND VALIDATION
Gaithersburg, MD, November 12, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced the promotion of William I. Braden, P.E., to the newly-
created position of Vice President, Engineering, Facilities and
Validation.
"Bill Braden has been a valuable contributor to MedImmune's growth during
his six years at the Company," commented Wayne T. Hockmeyer, Ph.D.,
Chairman and Chief Executive Officer. "We are fortunate to have someone
with Mr. Braden's talent, experience and tenacity to lead our efforts in
the design, construction and start-up of commercial manufacturing
operations at MedImmune."
Mr. Braden, 44, has over 21 years of experience in engineering,
validation, process scale-up and manufacturing in the pharmaceutical
industry. He has been involved with the construction, validation and
engineering of 12 biopharmaceutical manufacturing facilities in
compliance with FDA Current Good Manufacturing Practice (cGMP)
guidelines. At MedImmune, Mr. Braden has been Director of Manufacturing
since 1990 where he has held various responsibilities including raw
material supplies procurement, vendor contracting, facilities
validation, construction management and engineering management. Most
recently, Mr. Braden has served as MedImmune's project director for two
new construction projects, a 68,000 square foot manufacturing facility
in Frederick, Maryland and a 12,000 square foot pilot plant in
Gaithersburg, Maryland.
Prior to joining MedImmune, Mr. Braden was Manufacturing Project Manager
at Alcon Laboratories, Inc. in Fort Worth, Texas where he led a
manufacturing team to improve the production efficiency of certain eye
care products. From 1984 to 1988, Mr. Braden was Director of
Manufacturing at Praxis Biologics in Sanford, North Carolina where he
established the manufacturing department and developed the manufacturing
process and facility for the production of Haemophilus influenzae type B
(Hib) vaccines. From 1982 to 1984, Mr. Braden was Director of
Engineering at Damon Biotech, Inc. where he led the construction and
validation of a number of biotechnology manufacturing facilities
including one for monoclonal antibody production. Mr. Braden began his
pharmaceutical career at Schering-Plough Corporation in 1977 where he
was project leader for the process design scale-up and production of
alpha interferon. Mr. Braden is a graduate of Iowa State University in
civil engineering and a cum laude graduate of the New Jersey Institute
of Technology in chemical engineering. He holds an MBA in production
management. Mr. Braden is a Registered Professional Engineer in Texas,
North Carolina, Massachusetts, New Jersey and New York and holds several
patents for the purification of pharmaceutical products.
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. MedImmune currently
markets two products through its hospital-based sales force and has six
new product candidates in clinical trials. MedImmune is located in
Gaithersburg, MD.
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. MedImmune cannot predict the timing
or outcome of regulatory approval processes.
MEDIMMUNE COMMENCES PHASE 3 TRIAL TO EVALUATE RESPIRATORY SYNCYTIAL
VIRUS MONOCLONAL ANTIBODY
Gaithersburg, MD, November 20, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it has commenced a randomized, double-blind, placebo-
controlled Phase 3 clinical trial to evaluate the safety and efficacy
of MEDI-493, a humanized monoclonal antibody, for the prevention of
serious respiratory syncytial virus (RSV) disease in high-risk infants.
The clinical trial, known as IMpact-RSV, is being conducted at more
than 130 clinical centers in the United States, Canada and the United
Kingdom and is expected to include approximately 1,200 premature
infants and children with bronchopulmonary dysplasia (BPD). The
Company believes IMpact-RSV is the largest prospective clinical trial
ever conducted in this patient population. Patient enrollment is
expected to be completed later this year and results should be
available in the third quarter of 1997. RSV is the leading cause of
pneumonia and bronchiolitis in infants and small children. MedImmune
has retained exclusive worldwide marketing and manufacturing rights to
MEDI-493.
MEDI-493 is a humanized monoclonal antibody which binds to the fusion
protein of the RSV virus. In laboratory experiments, MEDI-493 has been
shown to neutralize the RSV virus and to reduce infection in an animal
model. MedImmune has previously tested MEDI-493 in Phase 1 and Phase 2
clinical trials involving approximately 300 patients for both the
prevention and treatment of RSV disease. MEDI-493 is administered by
intramuscular injection and, consequently, if successfully developed,
could be easier to use than MedImmune's first generation product for
RSV, RespiGam (Respiratory Syncytial Virus Immune Globulin Intravenous
(Human)) which requires a two to four hour intravenous infusion.
"MEDI-493 provides an opportunity for MedImmune to build on the
business which we have begun to establish with our first generation
product for RSV, RespiGam," commented David M. Mott, President and
Chief Operating Officer. "Because MEDI-493 is given by intramuscular
injection rather than by intravenous infusion, we believe 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, these benefits provide the potential to reach
a broader population of children with MEDI-493 than with our first
generation product for RSV."
The IMpact-RSV trial is designed to evaluate the safety and efficacy of
MEDI-493 for the prevention of serious RSV disease in high-risk
infants. Children will be enrolled in the trial who are 24 months of
age or younger with a diagnosis of BPD, or who were 35 weeks gestation
or less at birth and are six months of age or younger at the time of
enrollment. Children will be randomized in a 2:1 ratio to receive MEDI-
493 (15mg/kg) or placebo by intramuscular injection every 30 days from
November to April for a total of up to five injections. The primary
endpoint of the clinical trial is the incidence of RSV hospitalization
(confirmed by RSV antigen test).
RSV is the most common cause of lower respiratory infections in infants
and children worldwide. In the Northern Hemisphere, RSV outbreaks
typically occur during the late fall, winter and early spring. Normal
children and individuals with adequate immune systems often acquire a
benign chest cold when infected with RSV. In contrast, premature
infants and children with BPD are at increased risk for acquiring
severe RSV disease, often requiring hospitalization. In the United
States alone, over 90,000 children are hospitalized and 4,500 die from
RSV disease annually. The cost of treating a child hospitalized for
RSV can be over $70,000.
RespiGam is a polyclonal antibody licensed by the FDA on January 18,
1996 for the prevention of serious lower respiratory tract infection
caused by RSV in children under 24 months of age with BPD or a history
of premature birth (less than or equal to 35 weeks gestation). RespiGam
is the only product demonstrated to be safe and effective in reducing
the incidence and duration of RSV hospitalization and the severity of
RSV illness in these high-risk infants (Please see full prescribing
information). RespiGam is currently being launched by MedImmune in
partnership with the Wyeth-Lederle Vaccines and Pediatrics sales force
of American Home Products Corporation (NYSE:AHP). MedImmune has
established a collaboration with Baxter Healthcare Corporation
(NYSE:BAX) for commercialization of RespiGam outside of North America.
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. MedImmune markets two
products through its hospital-based sales force and has six new product
candidates in clinical trials. RespiGam is manufactured by
Massachusetts Public Health Biologic Laboratories. MedImmune is
located in Gaithersburg, MD.
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. MedImmune
cautions that the safety and effectiveness of MEDI-493 have not been
demonstrated and the outcome of the IMpact-RSV trial cannot be
predicted. Substantial risk and uncertainty remain until the trial is
concluded and data are known.
MEDIMMUNE APPOINTS FORMER CHIRON EXECUTIVE TO
VICE PRESIDENT OF BUSINESS DEVELOPMENT
Gaithersburg, MD, November 21, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced that former Chiron Corporation executive, Michael S.
Richman, has been appointed to the newly created position of Vice
President, Business Development. Mr. Richman will report to David M.
Mott, President and Chief Operating Officer, and will be responsible
for business development, licensing and intellectual property.
"Business development will be a critical component of MedImmune's
future growth as a vertically integrated biotechnology business,"
commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive
Officer. "We are fortunate to have someone with Mike's breadth of
experience, talent and commitment to lead our business development
activities."
Mr. Richman, 35, joins MedImmune with over 13 years of experience in
the biotechnology industry. Since 1985, he has held various positions
at Chiron where he most recently served as Director, Corporate Business
Development. His responsibilities included negotiating licensing and
strategic alliance agreements, coordinating partnering strategies, and
identifying, evaluating, and acquiring new technologies for multiple
business units at Chiron. In particular, Mr. Richman was instrumental
in formalizing collaborations and relationships with NABI, Progenitor,
GalaGen, Virus Research Institute, and Focal on behalf of Chiron
Vaccines and Chiron Technologies. In 1993, Mr. Richman received his
MBA from San Francisco State University in International Business.
Prior to serving as Director, Mr. Richman held the position of Manager,
Business Development (1990-1992). From 1988-1990 he served as Manager,
Intellectual Property, where he coordinated and managed the filing and
prosecution of U.S. and foreign patent applications, including Chiron's
hepatitis C virus patent application. Mr. Richman started at Chiron as
a Research Associate, where he developed yeast expression systems for
therapeutics and food industrial enzymes. Prior to joining Chiron, Mr.
Richman began his career as a Research Associate at Microgenics
Corporation, where he participated in building a start-up diagnostics
company. Mr. Richman holds a B.S. degree from the University of
California at Davis in genetics and molecular biology.
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. MedImmune currently
markets two products through its hospital-based sales force and has six
new product candidates in clinical trials. MedImmune is located in
Gaithersburg, MD.
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.
November 22, 1996
To Our Shareholders:
During the third quarter 1996, MedImmune continued with steady progress
in several key areas. Preclinical studies and clinical lot production
of MedImmune's first human papillomavirus (HPV-11) vaccine candidate
neared completion. Plans for commencing what we believe is the first
human clinical trial of a prophylactic HPV vaccine are underway. These
studies should commence late this year or early next year. As
previously reported, the Company broke ground on an approximately $50
million manufacturing facility in Frederick, Maryland. Construction
progress at the site to date has been steady.
One of our research programs, focused on the development of a vaccine
for the prevention of recurrent urinary tract infections in women, has
been making considerable strides. Urinary tract infections are
responsible for over eight million office visits each year in the
United States with an estimated annual health care cost of
approximately $4 billion. A recent publication in the New England
Journal of Medicine by investigators at the University of Washington
has highlighted the magnitude of this problem by showing that many
college-age women will have a urinary tract infection almost once a
year. Studies at MedImmune have demonstrated that immunization with a
protein which promotes adhesion of the most common urinary tract
pathogen, Escherichia coli, to bladder cells can prevent bacterial
colonization in a small animal model. This is an important
demonstration of protection against infection with a bacterial
"adhesin" protein. MedImmune will be conducting further studies in
primates in the fourth quarter, and expects completion of preclinical
development of the vaccine in 1997.
During the quarter, MedImmune continued to increase sales of CytoGam.
As shown in the accompanying earnings press release, product sales this
year to date of $18.1 million were 63% greater than total product sales
during the same period last year, largely due to CytoGam sales growth.
During the third quarter, CytoGam was placed on 41 new protocols in
U.S. transplant centers. While we are focused on achieving growth in
CytoGam sales over time, competition from antiviral agents is
significant and increasing.
In the rest of this report, we will focus on what may be the Company's
most visible near-term milestones. This includes the full launch of
RespiGam this fall and the commencement of a large Phase 3 clinical
trial for MEDI-493.
Launch of RespiGam
As the winter and the respiratory syncytial virus (RSV) season
approaches, MedImmune has begun the full launch of RespiGam. RSV is
the leading cause of pneumonia and bronchiolitis in infants and small
children. In the United States, it is estimated to cause over 90,000
hospitalizations and 4,500 deaths each year. RespiGam, approved
January 18, 1996 by the FDA, is the only product demonstrated to be
safe and effective in reducing the incidence and duration of RSV-caused
hospitalizations in certain high-risk infants including infants with
bronchopulmonary dysplasia and prematurity (less than or equal to 35
weeks gestation).
In preparation for the launch of RespiGam, MedImmune has focused on
obtaining third party payor approvals for reimbursement as well as
working to achieve managed care and hospital acceptance. To date, 50
of 51 Medicaid plans have approved the use of RespiGam for in-patient
and out-patient infusions and the majority of Medicaid plans also now
cover it in the home health care setting. In addition, 88 of the
largest managed care organizations have approved RespiGam for
reimbursement. Also, a significant number of the largest neonatal and
pediatric hospitals have added RespiGam to their formularies and
developed protocols for its use.
We believe the primary marketing challenges during this first season
will center around pharmacoeconomics and patient compliance. Although
evaluation of the pharmacoeconomics, or cost-effectiveness, of RespiGam
will continue to be refined as a greater number of patients use the
drug, two recent journal articles have been published regarding this
subject. An article in The American Journal of Managed Care (Vol. 2,
No. 7, pp. 851-861) by Dr. Joel Hay from the Department of
Pharmaceutical Economics and Policy, University of Southern California,
et al, estimates that at $4,500 per average cost of a full course of
RespiGam, the cost per year of life saved is in the range of $10,000 to
$32,000 and compares favorably with other medical interventions.
Another article published in The Journal of Pediatrics (Vol. 129, No.
2, pp. 214-219) suggests that the ancillary ability of RespiGam to
decrease the incidence of middle ear infections enhances the cost-
benefit of RespiGam. In the PREVENT study, RespiGam was also shown to
reduce the incidence of all respiratory hospitalizations, not only
those related to RSV. Certainly, additional studies will be conducted
to further evaluate the cost-effectiveness of RespiGam as additional
data are available.
The length of RespiGam administration - a two to four hour intravenous
infusion -presents particular challenges in assuring proper compliance
and appropriate use of RespiGam. Accordingly, MedImmune has developed
an innovative parental support and educational program called REACH
(RSV Education And Counseling Helpline) designed to address this
challenge. REACH provides hospital physicians and nurses with
educational tools to inform parents about RespiGam therapy and the
dangers of RSV disease, reminds parents about infusion appointments,
provides access to professional nurses for questions, supplies
reimbursement information, and notifies the patients' pediatricians
about infusion compliance. As part of the REACH program, nurses from
the Visiting Nurse Association (VNA) call parents of RespiGam
recipients pre- and post-infusion to answer questions and remind
parents of infusion appointments. REACH also provides a powerful
market monitoring tool for the Company; REACH participants are entered
into a national database, managed and regulated by the VNA, which will
enable MedImmune to monitor selected RespiGam summary statistics such
as infusion compliance and patient demographics. To date, 246
hospitals have confirmed their intent to participate in the REACH
program.
MEDI-493 RSV Monoclonal Antibody
The Company has recently begun an approximately 1,200 patient, 130
center, double-blinded, placebo-controlled, Phase 3 clinical trial of
MEDI-493, an RSV monoclonal antibody which is delivered by an
intramuscular injection, rather than by an intravenous infusion. If
MEDI-493 is shown to be safe and efficacious and subsequently approved
by the FDA, it could possess certain advantages over RespiGam. The
most important, perhaps, involves ease of use. All factors being
equal, market research indicates that a parent of a premature infant is
more likely to employ RSV preventative therapy and comply with its full
course if protection could be provided by a rapid, convenient injection
in the pediatrician's office rather than a two to four hour infusion in
the hospital.
MEDI-493 has completed preclinical studies and Phase 1 and 2 clinical
trials in adults, children and infants. These clinical studies were
primarily conducted to evaluate the safety of the agent at various
doses. Based on results from all of these studies, the Company has now
begun the Phase 3 clinical trial to assess the safety and efficacy of
MEDI-493. Despite all the studies completed to date which MedImmune
believes warrant conducting this trial, the Company believes it is
important to recognize that substantial risk and uncertainty remains
until the study is concluded and the data are known.
Conclusion
This is an exciting and challenging time for MedImmune. We look
forward to keeping you apprised of the Company's progress and, as
always, very much appreciate your continued support.
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.
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: November 22, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
