Form 8K Clinical Trial Enrollment
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 8-K
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CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report
December 27, 2001
Commission File No. 0-19131
MedImmune, Inc.
(Exact name of registrant as specified in its charter)
Delaware 52-1555759
(State or other jurisdiction of (I. R. S. Employer
incorporation or organization) 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
ITEM 5. OTHER EVENTS
The Company issued the following press release on December 27, 2001.
MEDIMMUNE COMPLETES ENROLLMENT IN CLINICAL TRIALS FOR
SYNAGIS® AND SIPLIZUMAB
Gaithersburg, MD, December 27, 2001 -- MedImmune, Inc. (Nasdaq: MEDI) announced today the completion of enrollment in two previously
announced clinical trials for Synagis (palivizumab), a product that prevents serious respiratory syncytial virus (RSV) disease in
certain high-risk infants, and siplizumab, a drug being developed as a potential psoriasis treatment. For Synagis, 1,287 infants
under 24 months of age with congenital heart disease (CHD) have been enrolled in a Phase III study, dosing for which should complete
in the second quarter of 2002. For siplizumab, 420 psoriasis patients have been enrolled in a Phase II study. Dosing is projected to
be complete during the first quarter of 2002.
"We are very pleased with the continued progress of our pipeline," said Dr. Franklin Top, MedImmune's executive vice president and
medical director. "We remain focused on both expanding the label of our current products and bringing new and important products to
market. As such, we hope that the data from the Synagis cardiac trial may provide support for the use of the drug in children
throughout the world suffering with CHD who are at an increased risk of hospitalization due to RSV infection. Additionally, we
continue to accumulate an increasing amount of data on the safety and efficacy of siplizumab in psoriasis as we target the
initiation of Phase III clinical testing in 2002."
The Phase III Synagis study is a randomized, double-blind, placebo-controlled trial and is being conducted in the United States,
Canada, United Kingdom, France, Germany, Sweden, and Poland. Eligible children with congenital heart disease are randomized
one-to-one to receive monthly injections of Synagis at 15mg/kg or placebo during the RSV season. The primary objective of the study
is to evaluate the safety and efficacy of Synagis in reducing RSV hospitalization in pediatric patients with CHD. The trial was
initiated in the fall of 1998 and will continue through the current RSV season. Analysis is anticipated to be completed by the fall
of 2002.
The Phase II siplizumab study is a randomized, double-blind, placebo-controlled trial involving patients with plaque psoriasis on at
least 10 percent of their body surface area and a minimum PASI (Psoriasis Area and Severity Index) score of eight. In this study,
eligible patients are randomized to receive one of three regimens of siplizumab or placebo. The study, initiated in September 2001,
is being conducted at 44 centers in North America and is designed to compare the safety and disease activity (PASI) in each of the
groups.
About Synagis and RSV
Synagis is a humanized monoclonal antibody approved and available for the prevention of serious lower respiratory tract disease
caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease (see full prescribing information at
http://www.medimmune.com/products/synagis/index.asp). It is administered by intramuscular injection at 15 mg/kg and is given once
per month during anticipated periods of increased RSV prevalence in a given community. In the Northern Hemisphere, the RSV season
typically commences in September and lasts through April or May.
RSV is the most common respiratory infection in infancy or childhood, resulting in over 125,000 hospitalizations annually in
children less than one year of age. Approximately two-thirds of all infants are infected with RSV during the first year of life, and
nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely or with
chronic lung disease or congenital heart disease are at highest risk of severe disease and hospitalization due to RSV. Congenital
heart disease is the name given to any heart defect or malformation that is present at birth. According to the American Heart
Association, CHD is the most common of all major birth defects, occurring in about eight out of 1,000 live births, or approximately
32,000 babies born every year in the United States.
About Siplizumab
Siplizumab is a humanized monoclonal antibody that binds to the CD2 receptor found on the surface of T-cells and natural killer (NK)
cells. By binding to CD2, siplizumab selectively suppresses the function of T-cells and NK cells. T-cells are an essential part of
the pathophysiology of psoriasis, and it is believed that modulation of T-cell activities may be therapeutically advantageous in the
treatment of psoriasis. Psoriasis is a chronic illness affecting as many as six million Americans. Annual outpatient costs in the
U.S. for psoriasis management have been estimated to be more than $1 billion.
MedImmune has a comprehensive development program underway with siplizumab. Currently, the company has three Phase II trials
underway, all now fully enrolled: a randomized, double-blind, placebo-controlled, subcutaneous administration trial involving 420
patients at 44 sites in North America; a randomized, double-blind, placebo-controlled, intravenous administration trial involving
124 patients at approximately 25 sites in North America; and a randomized, double-blind, subcutaneous administration trial involving
121 patients at approximately 20 sites in Europe. Data from MedImmune's Phase I program was presented in September at the European
Society of Dermatology Research meeting held in Stockholm, Sweden, which built upon the preliminary data presented in San Francisco
in June at the International Psoriasis Symposium and European Congress on Psoriasis. The updated data provided longer-term safety
analysis for two trials using intravenous administration, as well as clinical data from a subcutaneously administered trial. Overall
in these studies, siplizumab was found to be generally well tolerated, and was shown to improve psoriatic disease as measured by
PASI score given either intravenous or subcutaneous administration. The follow-up of patients in the Phase I program was consistent
with the preliminary safety and clinical results, and showed that improvement in patients' psoriasis appears to be durable after
completion of treatment at least through the initial three month follow-up period in these trials.
MedImmune acquired exclusive worldwide rights to siplizumab from BioTransplant Incorporated (Nasdaq: BTRN) in 1995. Siplizumab is
the humanized form of BioTransplant's murine monoclonal antibody, BTI-322. BioTransplant has retained the right to use BTI-322
and/or siplizumab in its proprietary ImmunoCognance™ systems, which are designed to re-educate the immune system to accept
foreign tissue: the AlloMune™ System for human-to-human transplantation, and the XenoMune™ System for porcine-to-human
transplantation. BTI-322 was initially discovered by Drs. Herve Bazin and Dominique Latinne at the Experimental Immunology Unit of
the Catholic University of Louvain in Belgium.
MedImmune, Inc. is a biotechnology company focused on developing and marketing products that address medical needs in areas such as
infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in
Frederick, Maryland and Nijmegen, the Netherlands.
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. The company is developing several products for potential future
marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory
clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.
SIGNATURES
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)
/s/: Gregory S. Patrick
Date: December 27, 2001 Gregory S. Patrick
Senior Vice President and Chief Financial Officer