ROCKVILLE and GAITHERSBURG, Md., March 16 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - News) and MedImmune, Inc., announced today that they have signed an agreement under which MedImmune will lease a portion of the HGS headquarters facility located in Rockville, MD, for the development and manufacturing of clinical trial material for cell culture-based seasonal and pandemic influenza vaccine. The expanded capability will support MedImmune’s commitment to pandemic influenza vaccine development per a five- year, approximately $170 million contract awarded last year by the U.S. Department of Health and Human Services (HHS)(1). The financial terms were not disclosed.
“While we are currently expanding our biologics manufacturing facility in Frederick, MD for potential use in producing pandemic vaccine as well as other products in our pipeline, the immediate availability of the existing Human Genome Sciences facility allows us to expedite certain development steps toward expanding our capacity to produce cell culture-based influenza vaccines,” stated Alan Taggart, MedImmune’s vice president of government project management. “This should be particularly useful as we prepare to initiate our clinical trials of cell culture influenza vaccine under our HHS contract commitment.”
MedImmune currently develops, manufactures and markets FluMist® (Influenza Virus Vaccine Live, Intranasal), a live, attenuated, needle-free seasonal influenza vaccine. The company is also working with the National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to apply MedImmune’s proprietary technology to develop pandemic influenza vaccines.
“HGS and MedImmune work together in a number of ways to advance the interests of the biotechnology industry in Maryland and the Greater Washington region, and we are pleased to extend use of this state-of-the-art facility to MedImmune -- particularly for such an important national purpose,” said Curran Simpson, HGS senior vice president of operations. “Our priority focus at HGS is to advance our lead products toward commercialization as rapidly as possible. To that end, we have taken a number of steps to strengthen our financial position and reduce net cash burn, including a facilities consolidation program. This lease is one outcome of that effort.”
Currently, all U.S.-approved influenza vaccines are made in chicken eggs; however, using chicken eggs as the production medium limits scalability in manufacturing and increases the potential risk of manufacturing delays or supply shortages. A severe outbreak of avian influenza could kill the flocks that produce the eggs needed for vaccine production. To address these concerns, MedImmune will be applying advanced cell culture-based manufacturing methods to produce influenza vaccines eliminating the need for chicken eggs. The success of this technology will reduce production times and substantially increase MedImmune’s U.S.-based manufacturing capacity to provide influenza vaccine to the U.S. population. After adding the cell culture-based production capability for its influenza vaccine, MedImmune anticipates having the capacity to produce 300 million monovalent bulk doses of a pandemic vaccine annually by 2012.
About FluMist
FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.
Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.
In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness. For information for indications and usage, dosage and administration, and safety information, please see the current Prescribing Information at http://www.flumist.com/pdf/prescribinginfo.pdf, visit www.flumist.com, or call 1-877-633-4411 for additional information.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company’s website at www.medimmune.com.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company’s primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon® for hepatitis C, and LymphoStat-B® for lupus. Phase 3 clinical trials of both compounds are now underway. For more information, visit the HGS web site at www.hgsi.com. HGS, Human Genome Sciences, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
(1) This project has been funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract No. HHS0100200600010C.
Source: Human Genome Sciences, Inc.
