As long as it all keeps coming - and a smattering of order...

As long as it all keeps coming - and a smattering of order confirmations, we should have a very healthy share price BEFORE the full year reporting in May. That will all help the May rise be a very significant one.

Biota And MedImmune Announce Collaboration To Develop New Therapies For RSV
Infection
Melbourne Australia and Gaithersburg Maryland USA, 15 December 2005
Biota Holdings Limited (ASX: BTA) and MedImmune, Inc. (Nasdaq: MEDI) announced today that
they 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 world leader in developing medicines for prevention, 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.
“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, PhD, MedImmune’s Senior Director, Infectious Disease Research.
“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.”
Under the terms of the agreement, Biota will receive an upfront payment of US$5 million and
reimbursement of future research and development expenses on the collaborative RSV program.
In addition, Biota could receive payments up to US$107.5 million based on achieving certain
clinical and regulatory milestones; and a royalty on sales of a future licensed 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.
“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.”
Contacts
Biota Holdings Limited MedImmune, Inc.
Investors: Investors:
Peter Cook +61 3 9915 3720 Peter Vozzo, 301-398-4358
Damian Lismore +61 3 9915 3721 John Filler, 301-398-4086
Media: Media:
Tim Duncan +61 3 9600 1979 Jamie Lacey, 301-398-4035
http://www.biota.com.au http://www.medimmune.com
For Immediate Release
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 hospitalisation 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™, 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 paediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere
during the winter months. Synagis is a humanised 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, Labour 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,
diarrhoea, 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™ 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® influenza diagnostics, currently marketed in the US. For more information, visit the
company’s website at 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.