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AM-Pharma announces start of second Phase II trial in Acute Renal Failure
Additional Phase II trial aims to confirm earlier positive results


Bunnik, The Netherlands, 9 July 2008. AM-Pharma B.V., the biopharmaceutical company developing improved endogenous proteins and peptides against inflammatory and infectious disease, today announced the start of a second Phase II trial of bovine derived Alkaline Phosphatase to treat Acute Renal Failure. The trial will be double blind placebo controlled and will include 26 patients.

This second Phase II trial is expected to confirm and strengthen the results of an earlier exploratory trial with Alkaline Phosphatase in Acute Renal Failure, which was announced in March 2007. At that time AM-Pharma showed a strongly reduced need for dialysis and increased survival after treatment in a double blind placebo controlled Phase II trial in 16 Acute Renal Failure patients,

The trial will be managed by AM-Pharma’s own clinical team and will be conducted at the critical care units of Nijmegen University hospital and Isala hospital in Zwolle, The Netherlands.

Bart Wuurman, CEO commented: “The very encouraging results in patients with Acute Renal Failure in our first exploratory Phase II trial motivate the start of this second trial, which is designed to show a statistically significant reduction in serum creatinine levels and a reduced need for dialysis. We are very excited by the potential of our product in Acute Renal Failure, as it could become the first drug to be approved for this highly prevalent and often lethal medical condition.”

In May this year AM-Pharma announced the first tranche of a €20 million series C fundraising. Once the full C round has been closed, AM-Pharma will make a switch from bovine Alkaline Phosphatase to a recombinant form of enhanced human Alkaline Phosphatase. This switch to the medically and commercially more attractive recombinant material is justified by the positive results of the first trial in Acute Renal Failure and by the positive results of another Phase II trial with Alkaline Phosphatase in Ulcerative Colitis. Recombinant material will be used in all future trials.

-Ends-

Notes to editors:

About Acute Renal Failure

Acute Renal Failure represents a large and increasing unmet medical need, as it affects nearly 2 million people in the western world and is lethal in almost half of the cases. To date there are no drugs approved to treat Acute Renal Failure and in the US alone more than $10 billion is spent on management of this condition in Intensive Care units. A large proportion of these costs are spent on dialysis. Acute Renal Failure is often caused by sepsis, cardiac surgery and by drug toxicity. Serum creatinine levels are a widely accepted marker for kidney function.

About AM-Pharma www.am-pharma.com
AM-Pharma is a biopharmaceutical company focused on the preclinical and clinical development of novel compounds in the field of severe infectious diseases and inflammatory diseases. All its products are based on optimized endogenous molecules which combat disease using physiological defence mechanisms.

AM-Pharma is conducting Phase II clinical trials for two products; Alkaline Phosphatase for acute renal failure and ulcerative colitis; and Selective Immune Response Amplifying peptide hLF1-11 for the treatment of drug resistant hospital acquired infections.

AM-Pharma is based in Bunnik, The Netherlands with a staff of 15. The company is financed by, amongst others, Forbion Capital Partners and Inventages Venture Capital. Once product safety and efficacy have been established in Phase II trials, AM-Pharma will look for world-wide development and marketing partners for its products.

For further information, please contact

College Hill Life Sciences
Adam Michael / Justine Lamond
Tel: +44 (0)20 7866 7857
ampharma@collegehill.com

AM-Pharma
CEO Bart Wuurman
Tel: +31 (0)30 2289222
www.am-pharma.com


Publisher Contact Information:

College Hill Life Sciences
+44 (0)20 7866 7857
ampharma@collegehill.com

Company profile of AM-Pharma BV
Past press releases of AM-Pharma BV.

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