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 3, 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 press
release dated December 1, 1997:
MEDIMMUNE ENTERS AGREEMENT WITH BOEHRINGER INGELHEIM TO SUPPLEMENT
MANUFACTURING CAPACITY FOR MEDI-493
Gaithersburg, MD, December 1, 1997 -- MedImmune, Inc. (Nasdaq:MEDI) today
announced that it has signed a manufacturing and supply agreement with Dr
Karl Thomae GmbH ("Thomae"), a fully-owned subsidiary of Boehringer Ingelheim
and a world-leading manufacturer of biopharmaceutical products for
therapeutic use. Under the agreement, Thomae will supplement MedImmune's own
production capacity for MEDI-493 (palivizumab), a humanized monoclonal
antibody being developed by MedImmune for prevention of respiratory syncytial
virus (RSV) disease in high risk infants.
"We are delighted to have the opportunity to work with one of the premier
manufacturers of recombinant proteins worldwide. We believe that Thomae's
experience and capability in this field will strengthen our own core
competencies in commercial manufacturing of MEDI-493 and will accelerate the
availability of large quantities of MEDI-493," commented Wayne T. Hockmeyer,
Ph.D., Chairman and Chief Executive Officer of MedImmune.
The Thomae facility, in Biberach, Germany, is fully licensed by both the U.S.
and European regulatory authorities for commercial biologics production for
third parties and provides state-of-the-art cell culture production
capabilities. Boehringer Ingelheim has successfully introduced several
biopharmaceutical products into the market including, Alveofact for the
treatment of infant distress syndrome (IRDS), Actilyse (tissue plasminogen
activator) for thromboembolic diseases and Imukin (interferon gamma) for
chronic granulocytomatosis. MEDI-493 produced by Thomae will initially
supplement product made in MedImmune's Gaithersburg, Maryland facility.
MedImmune has also recently completed construction of a manufacturing
facility in Frederick, Maryland, and following start-up and validation
procedures expects to seek licensure to produce MEDI-493 at that facility.
MedImmune and Thomae have been working together pursuant to an interim
agreement since April 1997. Scale-up and production are already underway and
MedImmune expects to make periodic payments to Thomae in connection with
these activities through 1998.
"MEDI-493 is an important pediatric product," commented Professor Dr. Rolf
Werner, Head of Biopharmaceutical Manufacturing at Thomae. "Our experience
in manufacturing recombinant products in accordance with high economic and
safety standards should be beneficial in expediting the commercialization of
MEDI-493."
MEDI-493 is a humanized monoclonal antibody which has been evaluated in a
Phase 3 double-blind, placebo-controlled clinical trial for its ability to
prevent respiratory syncytial virus (RSV) disease in high-risk infants. The
Company expects by year end to submit to the FDA a Biologic License
Application (BLA) requesting marketing clearance of MEDI-493 in the United
States. The Company also plans to submit applications in 1998 requesting
marketing clearance in Europe and Canada.
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. The Company currently markets two
products through its hospital-based sales force and has five new product
candidates in clinical trials.
Boehringer Ingelheim, an international corporation with headquarters in
Ingelheim (Germany), operates in the pharmaceutical, biological and chemical
sectors. The Boehringer Ingelheim Corporation is represented on every
continent, with about 160 companies around the world. With its own research,
production and distribution facilities, it ranks among the top 20
pharmaceutical companies in the world.
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 there can be no assurance that
MEDI-493 will be licensed for marketing by regulatory authorities.
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.
(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) December 3, 1997
