MedImmune, Biota to collaborate on RSV infection therapies

By Angela McDaniels

Seattle, Dec. 14 - MedImmune Inc. and Biota Holdings Ltd. said 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.

"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," JoAnn Suzich, MedImmune's senior director of infectious disease research, said in a company news release.

"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, the companies said.

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 Oct. 20, the company said.

MedImmune's preventative therapies for the prevention of RSV include Synagis (palivizumab) - a one-monthly injection and the first monoclonal antibody approved for an infectious disease - a RSV/parainfluenzavirus type 3 vaccine in phase 1 testing and Numax, which is being evaluated in a phase 3 clinical trial. MedImmune said it hopes to bring Numax to market as an improvement over Synagis.

RSV is the most common respiratory infection in infancy or childhood. 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.

MedImmune is a pharmaceutical company based in Gaithursburg, Md., focused on infectious diseases, cancer and inflammatory diseases.

Biota is a antiviral research company with its headquarters in Melbourne, Australia.

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