MedImmune, Inc. Expands Patent Estate For Reverse Genetics With New Rights From Mount Sinai School of Medicine
GAITHERSBURG, Md., Dec. 7 /PRNewswire-FirstCall/ -- MedImmune, Inc. , maker of the intranasal influenza vaccine FluMist(R) (Influenza Virus Vaccine Live, Attenuated), announced today that it has taken another step towards becoming the world leader in advancing the development of new, more reliable and efficiently developed vaccines that prevent influenza. Toward this end, MedImmune has acquired exclusive worldwide rights to certain intellectual property owned by Mount Sinai School of Medicine for reverse genetics, including U.S. Patent Nos. 6,544,785 and 6,649,372. With this license, MedImmune has further strengthened its patent estate to now either own or have exclusive licenses to all of the key intellectual property (listed below) for this technology:
* Mount Sinai School of Medicine Plasmid Rescue Portfolio (WO 01/04333) * MedImmune Fundamental Reverse Genetics Portfolio (WO 91/03552) * Wisconsin Alumni Research Foundation Plasmid Rescue Portfolio (WO 00/60050) * St. Jude Children's Research Hospital Dual Promoter Plasmid Rescue Portfolio (WO 01/83794)
"The use of reverse genetics will allow MedImmune to improve the efficiency of producing new influenza vaccine strains on an annual basis, ultimately resulting in more reliable delivery of the vaccine to the public," said George W. Kemble, Ph.D., MedImmune's vice president of research and development, vaccines. "When used to produce pandemic influenza vaccine seeds, reverse genetics has the added benefit of enabling scientists to remove potentially pathogenic portions of the virus, thereby making the vaccine and its production safer."
Reverse genetics is a method of altering the influenza genome to produce vaccine seeds that are then used to produce the vaccine. Reverse genetics is an important breakthrough for manufacturing all influenza vaccines, because it is more efficient and reliable than current methods used to produce vaccine seeds. For pandemic vaccines, reverse genetics is even more important because it does not require vaccine manufacturers to work directly with the infectious, circulating pandemic strain, rather only segments of its genome. Due to these benefits, the technology is now being used by most manufacturing companies and the U.S. government in their development of pandemic vaccines.
"As a long time leader in the field of virology, our goal is to ensure that this important technology continues to be widely used to prepare for potential pandemics, while at the same time ensuring that research continues to find new and innovative uses for reverse genetics," said Dennis Charney, M.D., Dean for Academic and Scientific Affairs at Mount Sinai School of Medicine. "At MedImmune, we found partners who share this vision."
"MedImmune remains committed to making sure that the reverse genetics technology is accessible to public health officials in their efforts to protect people from pandemic strains of influenza," said Edward T. Mathers, MedImmune's senior vice president of corporate development. "Toward this goal, we will continue to work with government institutions and industry manufacturers to provide licenses to our entire intellectual property estate for both pandemic and interpandemic purposes to allow for the use of this critical technology in the commercialization of influenza vaccines."
Under the terms of today's agreement, Mount Sinai will receive an upfront fee, milestone payments and royalties on future product sales.
In the U.S., influenza causes seasonal epidemics of disease resulting in approximately 36,000 deaths each year, according the U.S. Centers for Disease Control and Prevention. A pandemic occurs when a novel strain of influenza virus circulates widely in the human population that has no prior immunity and is highly susceptible. Recent outbreaks of avian influenza in Asia emphasize the need for the United States to be prepared in the event of a pandemic.
MedImmune is actively involved in applying its technologies, including reverse genetics, as well as its expertise to pandemic preparedness. In September, MedImmune finalized a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to produce and test versions of the company's attenuated, live intranasal influenza vaccine against pandemic influenza strains.
Recent Progress with Influenza Vaccine Franchise
In September 2005, MedImmune submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for approval to use its refrigerator-stable formulation of FluMist, known as CAIV-T (cold adapted influenza vaccine, trivalent) in healthy individuals 5 to 49 years of age. The sBLA was based on results from a Phase 3 study comparing the immunogenicity of FluMist to CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations.
MedImmune is nearing completion of a large Phase 3 clinical trial directly comparing the relative efficacy and safety of CAIV-T with the standard injectable vaccine. The goal of the study is to provide the pivotal data to seek regulatory approval for use of the intranasal vaccine in children down to 6 months of age. This prospective, controlled, Phase 3 trial includes approximately 8,500 children between the ages of six months and 59 months, including those with a history of asthma and wheezing. It has been conducted at approximately 250 sites in North America, Europe and Asia. Efficacy in the trial will be measured by the reduction in the incidence of symptomatic culture-confirmed influenza that matched the strains in the vaccines. The primary safety comparison in the trial will be measured by the rate of medically significant wheezing after vaccination.
CAIV-T is an investigational intranasal, cold-adapted trivalent influenza vaccine. It is the next generation, refrigerator-stable formulation of FluMist, which is a frozen, live attenuated cold-adapted trivalent influenza vaccine. To date, the safety, tolerability and efficacy of CAIV-T has been studied in both healthy and at-risk populations between the ages of 6 weeks and 98 years. Some of these data were presented in October 2003 at the Fifth Annual Options for the Control of Influenza Conference in Okinawa, Japan.
FluMist is 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. Like any vaccine, FluMist does not protect 100 percent of individuals vaccinated. In studies of people between the ages of 5 and 49 years, runny nose was the most commonly reported side effect. Other common side effects included various cold-like symptoms, such as headache, cough, sore throat, tiredness/weakness, irritability, and muscle aches.
FluMist should not be used, under any circumstances, in anyone with an allergy to any part of the vaccine, including eggs; in children and adolescents receiving aspirin therapy; in people who have a history of Guillain-Barre syndrome; and in people with known or suspected immune system problems. Pregnant women and people with certain medical conditions, asthma, or reactive airways disease should not get FluMist.
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine (MSSM) is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. For example, the FDA has recently approved two therapeutic products and one medical device based on MSSM technology and there are six products based on MSSM technology in clinical development. Further indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2004 of $153.2 million. Mount Sinai now ranks 25th among the nation's medical schools in receipt of research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
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 2,200 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's Web site at http://www.medimmune.com .
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the development of CAIV-T as well as potential influenza vaccines using reverse genetics. 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 MedImmune's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such vaccines will receive required regulatory clearance or that, even if such regulatory clearance is received, such vaccines will ultimately achieve commercial success. There can be no assurance that even if such a vaccine is commercially available, that it will protect against a particular influenza strain or prevent a pandemic.MedImmune, Inc.
CONTACT: Media: Clarencia Stephen, +1-301-398-4073 or Jamie Lacey,+1-301-398-4035; Investors: Peter Vozzo, +1-301-398-4358 or John Filler,+1-301-398-4086; all of MedImmune