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Shield Signs Agreement for ST10-021 with AOP Orphan Pharmaceuticals AG



11/1/2010 1:15:42 PM

Wollerau, Switzerland, 1 November 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 €1.25m and further milestone-based payments of up to €1.75m. 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®, Tracleer® and Remodulin®. 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 €1m.

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

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

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

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

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.


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