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 17, 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
MEDIMMUNE, INC.
Current Report on Form 8-K
ITEM 5. OTHER EVENTS
MedImmune, Inc. reported the information contained in the following
press releases dated December 13 and 16, 1996.
MEDIMMUNE ANNOUNCES SECOND U.S. PATENT ISSUED FOR RESPIGAM
Gaithersburg, MD December 13, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced the United States Patent and Trademark Office has
issued patent No. 5,582,827 for RespiGam(Respiratory Syncytial Virus
Immune Globulin (Human)). The patent, which covers the material
composition of RespiGam is the second U.S. patent issued for the
product. The patent is owned by Massachusetts Health Research
Institute, Inc. and is exclusively licensed to MedImmune. MedImmune
also today announced the Commonwealth of Australia Patent Office has
granted patent No. 668,092 for the material composition of RespiGam.
"The issuance of this composition of matter patent for RespiGam
strengthens MedImmune's proprietary position established both by the
previously issued process patent and by Orphan Drug exclusivity granted
by the FDA," commented David M. Mott, President and Chief Operating
Officer of MedImmune.
RespiGam a polyclonal antibody preparation, is currently being launched
in the United States by MedImmune and its partner, American Home
Products Corporation (NYSE:AHP), to prevent serious illness caused by
respiratory syncytial virus (RSV) in certain high-risk infants.
MedImmune has established a collaboration with Baxter Healthcare
Corporation (NYSE:BAX) for commercialization of RespiGam outside of
North America. RSV is the leading cause of pneumonia and bronchiolitis
in infants and children.
Both the U.S. and Australian patents are titled Process of Screening
Plasma for Effective Antibody Titers Against Respiratory Syncytial
Virus and claim the composition of RespiGam which is an antibody
preparation containing an elevated level of neutralizing antibodies
against RSV. The first U.S. RespiGam patent No. 5,412,077 issued in
1995 describes a critical component of the process required to produce
the antibody preparation from pooled human plasma.
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. 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 COMPLETES PATIENT ENROLLMENT IN PHASE 3 TRIAL OF MONOCLONAL
ANTIBODY FOR RESPIRATORY SYNCYTIAL VIRUS
Gaithersburg, MD, December 16, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it has completed enrollment of 1,503 patients in a
randomized, double-blind, placebo-controlled Phase 3 clinical trial,
called IMpact-RSV. The trial is being conducted at 139 medical centers
in the United States, Canada and the United Kingdom to evaluate a
monoclonal antibody known as MEDI-493 for the prevention of serious
respiratory syncytial virus (RSV) disease in certain high-risk infants.
The trial began November 15, 1996 and is expected to be completed in
May 1997. Results should be available in third quarter 1997. RSV is
the leading cause of pneumonia and bronchiolitis in infants and small
children.
"We are pleased to have completed patient enrollment ahead of schedule
and to have exceeded our targeted total enrollment. These
accomplishments are a testament to the diligence and professionalism of
the many investigators involved in the trial and to the importance of
this potential new therapy for the parents of the 1,503 infants
enrolled in the IMpact-RSV trial," commented Wayne T. Hockmeyer, Ph.D.,
Chairman and Chief Executive Officer.
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. 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 a chronic lung condition called
bronchopulmonary dysplasia (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 high-risk child
hospitalized for RSV can be over $70,000.
MEDI-493 is a humanized monoclonal antibody which binds to a target on
the surface of the RSV virus, called the fusion or "F" protein, which
is necessary for the virus to infect cells. 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.
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 enrolled in the trial were 24 months of age or
younger with a diagnosis of BPD, or were 35 weeks gestation or less at
birth and six months of age or younger at the time of enrollment.
Children were randomized in a 2:1 ratio to receive MEDI-493 (15mg/kg)
or placebo by intramuscular injection approximately every 30 days from
November to April for a total of up to five injections. The primary
endpoint of the trial is the incidence of RSV hospitalization
(confirmed by RSV antigen test).
"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," added Dr. Hockmeyer. "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."
RespiGam is a polyclonal antibody licensed by the FDA in January 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.
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: December 17, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)
