Gaithersburg, MD, September 18, 2000 -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has presented data on several of its products and compounds at a number of recent medical conferences, indicating the advancement of its expanding product pipeline, including: data from two Phase III studies with Ethyol® (amifostine) at the 9th World Lung Cancer Conference in Tokyo, Japan (September 11-15); data presented today from a Phase I study with the company's urinary tract infection (UTI) vaccine at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto, Canada (September 17- 20); data from two post-marketing studies on Synagis® (palivizumab), one at the World Congress on Lung Health in Florence, Italy (August 30 – September 3) and one at the International Society for Pharmacoepidemiology in Barcelona, Spain (August 20-23); and data from a Phase I study with its human papillomavirus (HPV) vaccine to prevent cervical cancer at the 18th International Papillomavirus Conference in Barcelona, Spain (July 25-28).
“In the last 12 months our pipeline has made significant progress,” said Dr. James F. Young, MedImmune's executive vice president, research and development. “We have a well-balanced and broadly focused pipeline of products that address a cadre of serious medical conditions. We are pleased that clinical results from our efforts are starting to become available to medical scientists. We hope to continue increasing the flow of clinical and scientific information, thus further solidifying our position as a leading biotechnology company committed to bringing innovative new products to patients.”
Ethyol®/World Lung Cancer Conference As a chemoprotective agent, Ethyol is currently indicated to reduce the cumulative kidney toxicity (nephrotoxicity) associated with repeated administration of cisplatin in patients with advanced ovarian cancer and non-small cell lung cancer (NSCLC). To further investigate the efficacy of Ethyol in NSCLC patients, MedImmune Oncology (MedImmune's wholly owned, cancer-focused subsidiary) conducted two Phase III studies involving 366 and 300 patients, respectively. Data from these studies suggest that Ethyol reduces the impact of specific toxicities commonly associated with the use of certain chemotherapy agents in NSCLC patients. The data also suggest that Ethyol does not interfere with the desired anti-tumor activity of chemotherapy agents whether used alone or in combination.
Data from the first study indicated that Ethyol significantly reduced the incidence of nephrotoxicity in patients with advanced NSCLC receiving treatment with cisplatin in combination with vinblastine (p<0.0001). The study also showed that on a cumulative basis, patients receiving Ethyol were able to receive twice the amount of cisplatin than the control group before the first signs of nephrotoxicity occurred. Further, 30 percent of the control group dropped out of the study, or reduced or delayed their therapy due to nephrotoxicity, compared to 12 percent in the group treated with Ethyol (p<0.001). Overall, there was no statistically significant difference between the control group and the treated group as to tumor response, time to progression, or survival (hazard ratio = .804; p=0.060), supporting prior evidence that Ethyol does not reduce the desired anti-tumor activity of these chemotherapy agents.
The second study evaluated the ability of Ethyol to reduce neurotoxicities and hematologic toxicities commonly associated with the administration of paclitaxel in combination with carboplatin in patients with advanced NSCLC. Although Ethyol did not show a reduction in neurotoxicities in this study, probably due to a low incidence of such toxicities in both the control and treated groups, Ethyol did reduce the time needed for white blood cell counts to return to acceptable levels (p=0.045). Treatment with Ethyol also reduced the number of patients who discontinued the study, or reduced or delayed their chemotherapy from 38 percent to 28 percent. Additionally, the data in this trial showed that Ethyol did not affect the desired anti-tumor activity of paclitaxel/carboplatin combination therapy, nor did it impact survival (hazard ratio = 1.089; p=0.500).
According to the National Cancer Institute, cancers that begin in the lungs are divided into two major types, non-small cell lung cancer and small cell lung cancer. Non-small cell lung cancer is the most common, accounting for almost 80 percent of all lung cancers. According to the American Cancer Society, lung cancer will be diagnosed in an estimated 164,100 Americans, approximately 14 percent of all cancer diagnoses, and will cause approximately 156,900 deaths, accounting for 28 percent of all cancer deaths, in 2000.
Ethyol® is an intravenous cytoprotective agent marketed for the reduction of both cumulative nephrotoxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer or non-small cell lung cancer (“NSCLC”) and moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid (see full prescribing information at www.medimmune.com/medimmune/products/ethyol.htm). For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens is altered by Ethyol. There are at present only limited data on the effects of Ethyol on the efficacy of chemotherapy in other settings. Ethyol should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit or cure, except in the context of a clinical study. Ethyol is contraindicated in patients with known sensitivity to aminothiol compounds. Data presented at the World Lung Cancer Congress has not yet been submitted to the U.S. Food and Drug Administration for review.
Urinary Tract Infection Vaccine/ICAAC To test the safety and tolerability of its urinary tract infection (UTI) vaccine, MedImmune immunized 48 healthy, female volunteers in a Phase I, randomized, dose-escalating, placebo-controlled, double blind study. In this study, the vaccine was found to be safe, generally well tolerated and immunogenic. There was also evidence of a clear dose response: all volunteers receiving the vaccine developed serum antibodies and those with the best serum responses exhibited antibodies in urine and vaginal secretions. When studied in tissue culture, the antibodies were found to prevent the bacteria from binding to human bladder cells. The most common side effect observed in the study was mild to moderate pain at the injection site.
More than eight million people visit their physician annually due to urinary tract infections. Most are women between the ages of 15 and 45, but children, men and postmenopausal women are at risk as well. Most UTIs involve infection of the bladder and/or kidney, and more than 80 percent are caused by Escherichia coli (E. coli), a bacteria that occurs normally in the intestines. Currently, antibiotics are typically used to treat urinary tract infections.
Synagis®/International Society for Pharmacoepidemiology/World Congress on Lung Health
MedImmune continues to conduct a number of studies with Synagis to support its use in its currently approved indication, and to expand its applicability to broader markets. Data recently presented at two conferences continue to provide further evidence that RSV is a serious health risk and that treating high-risk patients with Synagis significantly reduces hospitalization rates and medical costs associated with RSV infection.
The study presented at the International Society for Pharmacoepidemiology was conducted by HealthPartners of Philadelphia to measure the impact of treating patients with Synagis on pulmonary-related hospitalizations and the average length of hospital stay in a Medicaid managed program. The study, involving 205 patients, concluded that guideline dissemination and pre-authorization of treatment with Synagis to prevent RSV in high-risk Medicaid patients is an effective policy tool for reducing pulmonary-related hospitalizations, average length of hospital stays, and related costs.
Data presented at the World Congress on Lung Health was from a retrospective study evaluating the costs of RSV hospitalization at a tertiary care children's hospital. The data showed that RSV continues to be a significant cause of expensive and prolonged hospitalizations in children, suggesting the ongoing need to prophylax high-risk patients against RSV infection.
Synagis is a humanized monoclonal antibody marketed 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 www.medimmune.com/medimmune/products/synagispi.htm).
HPV Vaccine/International Papillomavirus Conference
Approximately 24 to 40 million people in the United States are infected with some form of the human papillomavirus, of which there are over 80 types. Given that an estimated 70 percent of all cervical cancer, the second leading cause of death in women worldwide, is caused by either HPV-16 or HPV-18, there is an obvious need for a vaccine to prevent infection with HPV. To assess the safety of its HPV vaccine to prevent cervical cancer, MedImmune and its development partner, SB Biologicals (a division of SmithKline Beecham (NYSE: SBH), conducted a Phase I study with its HPV-16/HPV-18 vaccine involving 48 healthy, female volunteers. Data presented at the International Papillomavirus Conference demonstrated that in this study the vaccine was safe and generally well tolerated at the doses given. The study also indicated that the vaccine has the potential to induce the desired immune response and the potential to produce neutralizing antibodies.
SmithKline Beecham Biologicals, one of the world's leading vaccine manufacturers, is located in Rixensart, Belgium. Rixensart is the centre of all SB's activities in the field of vaccine research, development and production. SB Biologicals employs over 600 research scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections which cause serious medical problems worldwide. SB distributes over 770 million doses of vaccines per year for the developing and developed world. Every second, 25 doses of SB Bio vaccines are distributed to 160 countries around the world. For information, visit SmithKline Beecham's vaccine website at http://www.worldwidevaccines.com.
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.
MedImmune, Inc. is a fully integrated 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, and an oncology subsidiary in West Conshohocken, Pennsylvania.
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 RSV disease occurs primarily during the winter months; the company believes its operating results will reflect that seasonality for the foreseeable future. The company is also 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.