GAITHERSBURG, Md. and MELBOURNE, Australia, Dec. 14 /PRNewswire-FirstCall/ -- MedImmune, Inc. and Biota Holdings Limited announced today that they have entered into a licensing and collaboration agreement to develop and commercialize Biota’s small molecule compounds designed to prevent and treat respiratory syncytial virus (RSV) infection. MedImmune is the world leader in developing medicines for prevention of RSV, having successfully brought to market two preventative therapies. MedImmune currently markets Synagis(R) (palivizumab), the standard of care for helping to prevent serious RSV disease in high-risk infants. Licensed by the U.S. Food and Drug Administration in 1998, it was the first monoclonal antibody (MAb) approved for an infectious disease.
“As a company strongly committed to successfully developing and marketing anti-RSV therapeutic products, we are excited to expand our RSV research programs through this collaboration with Biota,” said JoAnn Suzich, Ph.D., MedImmune’s senior director, infectious disease research. “Whereas Synagis is an injectable monoclonal antibody approved for RSV prevention in high-risk pediatric patients, the Biota compounds are orally available drug candidates. If successfully developed, these products could expand the RSV market to other susceptible patient groups, such as older children, the elderly and individuals with compromised immune systems.”
Under the terms of the agreement, Biota will receive an upfront payment of $5 million and reimbursement of future research and development expenses on the collaborative RSV program. In addition, Biota could receive payments up to $107.5 million based on achieving certain clinical and regulatory milestones; and a royalty on sales of a future product brought to market by MedImmune under the agreement. Biota will have exclusive marketing rights in Australia, New Zealand, China and Southeast Asia (including India and Pakistan) for potential products developed as a result of the agreement. MedImmune will have exclusive marketing rights to these products for the United States, Europe, Japan and all other countries. The upfront payment to Biota was not included in MedImmune’s previously stated financial guidance for 2005 as issued on October 20, 2005.
“MedImmune is the ideal partner for our RSV program,” said Peter Cook, Biota’s chief executive officer. “This is a world-class deal that provides affirmation of the commercial value of Biota’s respiratory antivirals portfolio.”
About RSV
RSV is the most common respiratory infection in infancy or childhood. Approximately one-half 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 as well as those with chronic lung disease or congenital heart disease are at highest risk of severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., HIV patients or cancer patients undergoing chemotherapy).
MedImmune’s product development efforts currently underway for RSV prevention include a broad Phase 3 clinical trial program for Numax(TM), which the company hopes to bring to market as an improvement to Synagis, and a Phase 1 program for a vaccine that could potentially prevent both RSV and parainfluenzavirus type 3 (PIV-3). PIV-3 is another commonly occurring respiratory virus of childhood, causing bronchitis, bronchiolitis, croup, cough, fever and pneumonia.
About Synagis
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere during the winter months. Synagis is a humanized MAb given by an intramuscular injection once a month during the RSV season. Synagis was approved in 1998 by the U.S. Food and Drug Administration (FDA); in 1999, by the European Medicines Evaluation Agency; and in 2002, by the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded the U.S. label for Synagis for use in young children with hemodynamically significant congenital heart disease at risk of RSV disease. To date, Synagis has been approved in 62 countries, including the United States. Synagis has been used in more than half a million babies since 1998. Adverse events with Synagis may include upper respiratory tract infection, ear infection, fever, runny nose, rash, diarrhea, cough, vomiting, gastrointestinal upset and wheezing. Very rare cases of severe allergic reactions such as anaphylaxis (less than 1 case per 100,000 patients) have been reported following re- exposure to Synagis. Rare severe, acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to Synagis. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. For full prescribing information for Synagis, see the MedImmune website at http://www.medimmune.com/products/synagis/index.asp.
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 2,000 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company’s website at http://www.medimmune.com/.
About Biota
Biota is a world-leading antiviral research company with its headquarters in Melbourne, Australia. Biota was responsible for zanamivir, the first-in- class neuraminidase inhibitor, subsequently launched by GSK as Relenza(TM) for the treatment and prevention of influenza. Recent Biota research breakthroughs have included BTA798 (Human Rhinovirus), and a series of candidate drugs aimed at RSV (Respiratory Syncytial Virus). Biota is also engaged in early stage research targeting hepatitis C. Key partnerships: With Sankyo, Biota is developing second generation flu antivirals (called LANI or Long Acting Neuraminidase Inhibitors); with BioStar, Biota developed the FLU OIA(R) influenza diagnostics, currently marketed in the US. For more information, visit the company’s website at http://www.biota.com.au.
This announcement contains, in addition to historical information, certain “forward-looking statements” regarding the results of clinical trials and regulatory submissions for small molecule products designed to prevent or treat RSV. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change current expectations and could cause actual outcomes and results to differ materially from current expectations. In addition to risks and uncertainties disclosed in MedImmune’s filings with the U.S. Securities and Exchange Commission, MedImmune can provide no assurance that these products will be commercially successful. In addition, no assurance exists that development efforts for these products will succeed, that these products will receive required regulatory approval or that, even if regulatory approval is received, they will be commercially successful. MedImmune undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law or regulation.
MedImmune, Inc.; Biota Holdings Limited
CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,+1-301-398-4358, John Filler, +1-301-398-4086, all of MedImmune, Inc.; orMedia: Tim Duncan +61 3 9600 1979, or Investors: Damian Lismore +61 3 99153721, both of Biota Holdings Limited
