Shield Therapeutics Signs Agreement With AOP Orphan for ST10-021

By Shield Therapeutics, PRNE
Sunday, October 31, 2010

AOP Orphan to Make Strategic EUR3m Investment in Shield Holdings

WOLLERAU, Switzerland, November 1, 2010 - Shield Holdings AG (Shield), the independent specialty
pharmaceutical company focused on the development and commercialisation of
late-stage hospital pharmaceuticals, today announces that it has signed a
strategic commercialisation agreement for its lead asset, ST10-021, an iron
therapy product which has commenced Phase III clinical development, with AOP
Orphan Pharmaceuticals AG ("AOP"). AOP is a pharmaceutical company based in
Vienna specialising in the development and marketing of medicines for rare
and complex diseases.

Under the terms of the agreement, Shield, whose products
address areas of high unmet medical need, will receive an upfront payment of
EUR1.25m and further milestone-based payments of up to EUR1.75m. AOP will
receive commercialisation rights to ST10-021 in Central Eastern Europe and
the Middle-East, together with an equity stake in a subsidiary of Shield.

ST10-021, a novel stable complex of ferric iron in an oral
formulation, is being developed as a daily prescription pharmaceutical iron
therapy product with an initial indication for the treatment of iron
deficiency anaemia ("IDA") associated with inflammatory bowel disease
("IBD"). IDA is a significant complication of IBD, affecting approximately
73% of patients with ulcerative colitis or Crohn's disease globally1,2.
ST10-021 was acquired by Shield in Q1 2010 and has global patent protection
through 2026.

Shield recently initiated a pivotal Phase III programme for
ST10-021 as a treatment for IDA as a side-effect of both ulcerative colitis
and Crohn's disease. Two parallel clinical trials will commence patient
enrolment in 2011. The international, 12 week, multi-centre trials will
include approximately 120 patients each and the primary endpoint of the
studies will be measurement of haemoglobin improvement via a simple blood
test. Tests conducted to date in nearly 400 humans suggest that ST10-021 may
be safe and well tolerated, with the potential to provide a new therapy
option that could overcome the clear limitations of current treatments.

Currently available oral treatments for IDA demonstrate
limited effectiveness due to negative side-effect profiles and low levels of
compliance. Intravenous therapies also have limitations as they are
expensive, have the potential to cause hypersensitivity reactions and are
inconvenient due to the requirement for hospital-based administration. Rapid
absorption of ST10-021 in the upper gastro-intestinal tract may enable lower
dosing and may mitigate the risk of unwanted gastro-intestinal side effects
commonly observed with commercially available oral iron replacement
therapies. In addition, it appears that the efficacy of ST10-021 is not
dependent on an acidic gastric pH, so it may be able to be co-prescribed with
commonly used gastric-acid reducers.

Shield Therapeutics was founded in 2008 and is led by Carl
Sterritt
(Chief Executive Officer) and Dr Christian Schweiger (Chief Medical
Officer). Shield's management team has over 30 years experience in the
successful development and commercialisation of pharmaceuticals, most
recently including Thelin(R), Tracleer(R) and Remodulin(R). The team
previously successfully established and led the European operations of
Encysive Pharmaceuticals, before it was acquired by Pfizer Inc. in 2008.

The investment by AOP follows the completion of Shield's first
external funding round in May 2010 in which the Company raised EUR1m.

Commenting on today's announcement, Carl Sterritt, Chief
Executive Officer of Shield Holdings, said: "This investment by AOP provides
further significant independent validation of ST10-021 and its development
programme. It also has the added benefit of allowing Shield to leverage AOP's
leading track record in the commercialisation of drugs to treat complex
disease areas. We look forward to the initiation of patient recruitment into
the Phase III programme in 2011 and are working closely with Regulators to
best address the clear unmet medical need in the treatment of iron deficiency
anaemia in IBD patients."

Commenting on today's announcement, Dr Rudi Widmann, Chief
Executive Officer of AOP, said: "The cooperation between AOP and Shield will
allow both companies to add significant value to their business strategy. AOP
has a unique record of developing and distributing products for rare and
complex diseases, thus Shield will benefit from AOP's access to treatment
centres and its long term expertise in commercialising drugs for rare and
complex diseases in Central Europe and the Middle East."

References

1. Gasche C, Anaemia in Inflammatory Bowel Disease, Uni Med
Science 2008;

2. Kulnigg S, Gasche C. Systematic review: managing anaemia in
Crohn's disease. Aliment Pharmacol Ther 2006; 24:1507-152

About Shield

Shield, founded in 2008, is an independent specialty
pharmaceutical company focused on the development and commercialisation of
late-stage, mineral-derived hospital pharmaceuticals which address areas of
high unmet medical need. Shield is currently preparing to undertake a global
pivotal Phase III study of its lead asset, ST10-021, for the treatment of
iron deficiency anaemia associated with inflammatory bowel disease. The
Company is headquartered in Wollerau, Switzerland. For further information,
please visit www.shieldtherapeutics.com.

About AOP

AOP is a pharmaceutical company specialising in the
development and marketing of medicines for rare and complex diseases in
Haematology/Oncology, Cardiovascular Disease, Metabolic Disorders and
Neurology. The company is based in Vienna and is represented in all Central
European countries and the Middle East. AOP also commercialises its products
in South East Asia, South Africa and South America with a series of
distribution partners. The Company is headquartered in Vienna, Austria. For
further information, please visit www.aoporphan.at.

For more information about Shield, please contact:

    M:Communications

    Mary-Jane Elliott / Emma Thompson
    Tel +44(0)20-7920-2345
    E-mail: shield@mcomgroup.com

For more information about Shield, please contact: M:Communications, Mary-Jane Elliott / Emma Thompson, Tel +44(0)20-7920-2345, E-mail: shield at mcomgroup.com

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :