GAITHERSBURG, Md. and MELBOURNE, Australia, Dec. 14 /PRNewswire-FirstCall/
-- MedImmune, Inc. (Nasdaq: MEDI) and Biota Holdings Limited
(ASX: BTA) 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
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.
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/.
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.
SOURCE MedImmune, Inc.; Biota Holdings Limited
Jamie Lacey, +1-301-398-4035
John Filler, +1-301-398-4086
all of MedImmune, Inc.
Tim Duncan +61 3 9600 1979
Damian Lismore +61 3 9915
both of Biota Holdings Limited