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 6, 1996
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Commission File Number: 0-19131
Delaware 51-1555759
(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 on the following
press release dated June 6, 1996.
MEDIMMUNE SECURES BROAD PATENT COVERAGE
FOR HUMAN B19 PARVOVIRUS VACCINE
Gaithersburg, MD, June 6, 1996 -- MedImmune, Inc. (Nasdaq:MEDI)
today announced it has obtained through a cross-licensing agreement
exclusive rights to commercialize certain intellectual properties
held by a licensing arm of the University of Leiden, The Netherlands,
pertaining to the treatment and prevention of human B19 parvovirus
infections. These intellectual properties include technology
described in European patent number 0491824 issued to scientists at
the University of Leiden in October 1995 titled, "Human Parvovirus
B19 Proteins and Virus-Like Particles, Their Production and Their Use
in Diagnostic Assays and Vaccines." The license significantly
strengthens MedImmune's intellectual property position in this area
and enhances the geographic scope of the commercial opportunity for
MEDI-491, a human B19 parvovirus vaccine candidate currently being
developed by MedImmune. In addition, as part of the cross-licensing
agreement, MedImmune has granted exclusive rights to the University
of Leiden to commercialize B19 parvovirus diagnostic test kits.
Separately, MedImmune today announced that the United States Patent
and Trademark Office has issued patent number 5,508,186, titled "B19
Parvovirus Capsids" to scientists at the National Heart, Lung, and
Blood Institute (NHLBI) for isolated empty B19 parvovirus capsids
which form the basis of MEDI-491. This patent is licensed on an
exclusive, worldwide basis to MedImmune as part of a previous
agreement with NHLBI.
"The University of Leiden license, together with the issuance of the
Capsid patent previously licensed from the National Institutes of
Health strengthens MedImmune's proprietary position for MEDI-491, our
vaccine for human B19 parvovirus," commented David M. Mott, President
and Chief Operating Officer of MedImmune. "We believe that our human
B19 parvovirus is the leading vaccine development effort worldwide
for this important pathogen. Our efforts to secure broad worldwide
patent coverage for a B19 parvovirus vaccine are indicative of our
strategy to seek important intellectual properties in key areas of
our business."
MEDI-491 is a virus-like particle (VLP) based vaccine intended to
prevent human B19 parvovirus infection and was developed by MedImmune
and the NHLBI under a Cooperative Research and Development Agreement
(CRADA). MedImmune has completed a Phase 1 clinical trial evaluating
the safety and immunogenicity of MEDI-491 and plans to commence
additional clinical testing during 1996. A similar VLP vaccine
approach, taken by Dr. Caroline Brown, Dr. Willy Spaan and colleagues
at the University of Leiden Department of Virology, University
Hospital, has formed the basis of European patent number 0491824
which was licensed to MedImmune.
Discovered in 1975, B19 parvovirus has been linked to a number of
serious conditions including miscarriages in pregnant women, life-
threatening sudden reduction of red blood cells (transient aplastic
crisis) in sickle cell anemia patients, chronic anemia in AIDS and
chemotherapy patients, and persistent or acute arthritis in some
adults. The United States Center for Disease Control estimates that
the chances of miscarriage are as high as one in 40 if exposed to B19
parvovirus. In children, B19 parvovirus infection can cause erythema
infectiosum (or "Fifth Disease"), a condition distinguished by a
characteristic "slapped cheek" rash as well as benign flu-like
symptoms. It has been estimated that up to 60% of the population in
the United States has been infected with B19 parvovirus. There are
no agents available for the prevention of B19 parvovirus infection.
The Company believes a successful B19 parvovirus vaccine could be
used both to immunize women entering their child-bearing years to
protect them from experiencing B19 parvovirus-induced miscarriages
and to vaccinate children with sickle cell anemia to protect them
against transient aplastic crisis. In addition, a successful B19
parvovirus vaccine could be incorporated into routine childhood
immunization programs to reduce the prevalence of this virus, a
similar strategy to that applied to vaccines for rubella, a virus
which causes miscarriages and fetal abnormalities.
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 products in clinical trials. MedImmune is located in
Gaithersburg, MD.
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: June 6, 1996 David M. Mott
President and Chief Operating Officer
(Principal financial and accounting
officer)