MedImmune Inc. and Biota Holdings Limited have entered into a licensing and collaboration agreement to develop and commercialise Biota's small molecule compounds designed to prevent and treat respiratory syncytial virus (RSV) infection.
MedImmune is the one of the leaders in developing medicines for prevention of RSV, having successfully brought to market two preventative therapies. MedImmune currently markets Synagis (palivizumab), the standard of care for helping to prevent serious RSV disease in high-risk infants. Licensed by the US Food and Drug Administration in 1998, it was the first monoclonal antibody (MAb) approved for an infectious disease, states a company release.
"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. Whereas Synagis is an injectable monoclonal antibody approved for RSV prevention in high-risk paediatric 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," said JoAnn Suzich, MedImmune's senior director, infectious disease research.
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 programme. 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 programme. This is a world-class deal that provides affirmation of the commercial value of Biota's respiratory antivirals portfolio," said Peter Cook, Biota's chief executive officer.
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.
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in paediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere during the winter months.