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MedImmune, Inc. (MEDI) Files Investigational New Drug Application For Nasally Delivered RSV/PIV-3 Vaccine



10/19/2005 5:12:31 PM

GAITHERSBURG, Md., Jan. 20 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that is has filed an investigational new drug application (IND) to begin clinical studies of its respiratory syncytial virus (RSV) and parainfluenza virus type-3 (PIV-3) candidate vaccine. Data from preclinical studies indicate that the combination vaccine elicited protective immune responses to RSV and PIV-3, two leading causes of pediatric respiratory disease.

Upon the U.S. Food and Drug Administration's review and approval of the IND, MedImmune plans to initiate a Phase 1 clinical study for the RSV/PIV-3 candidate vaccine. The study will evaluate the safety, tolerability and immunogenicity of the vaccine in healthy adults who have had multiple years of exposure to wild type RSV and PIV-3.

RSV and PIV-3 are viruses that cause serious respiratory disease, particularly in young children, the elderly and immunocompromised individuals. RSV is the most common cause of lower respiratory tract infections in infants and children worldwide, typically occurring during the fall and winter months.

PIV-3 is the leading cause of croup, an acute lower respiratory disease most often observed in young children.

The RSV/PIV-3 candidate vaccine will leverage MedImmune's novel intranasal vaccine technology. Upon approval, the vaccine would have the potential to provide a new, needle-free option to help protect against two respiratory diseases that are responsible for significant healthcare expenditures annually.

"We believe that a vaccine engineered to target both the RSV and PIV-3 viruses will significantly reduce respiratory disease burden in children," said Richard Spaete, Ph.D., senior research director at MedImmune. "With more than 125,000 children hospitalized with RSV-related complications each year and thousands of children impacted by croup, the development of a safe and effective vaccine will be a significant public health milestone."

Preclinical studies have shown that a combination of the bovine and human versions of PIV-3 used as the vector in this new approach could be successfully constructed as a carrier to induce a protective immune response against PIV-3 and RSV.

Preliminary data from one such preclinical study of RSV/PIV-3 were published in the October 2004 issue of Journal of Virology. Results of this study, entitled "Parainfluenza Virus Type-3 Expressing the Native or Soluble Fusion (F) Protein of Respiratory Syncytial Virus (RSV) Confers Protection from RSV Infection in African Green Monkeys," helped fuel MedImmune's efforts to develop a novel RSV/PIV-3 vaccine.

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 approximately 1,900 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website 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 research and development of a potential RSV/PIV-3 combination vaccine product and a potential PIV-3/hMPV combination vaccine product. 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 products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.

MedImmune, Inc.

CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,+1-301-398-4358 or John Filler, +1-301-398-4086, all of MedImmune, Inc.


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