Positive Phase I Data For ZP1848 In Crohn's Disease

Zealand Pharma A/S ("Zealand Pharma" or "the Company")

Positive Phase I data for ZP1848 in Crohn’s Disease

~ Study findings demonstrate significant increase in citrulline levels indicating enhanced gut function ~

GLOSTRUP, DENMARK and COPENHAGEN, DENMARK -- (MARKET WIRE) -- 10/15/10 --Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, today announces positive results from a Phase I trial of ZP1848 for the treatment of Crohn’s disease. ZP1848 is a potent and selective GLP-2 agonist discovered by Zealand Pharma that is targeted to offer a novel treatment option for patients with Crohn’s disease due to its regenerative effect on the intestinal surface and enhancement of intestinal function.

The Phase I clinical study was conducted in 60 healthy volunteers and 10 Crohn’s disease patients in remission. ZP1848 was found to be safe and well tolerated. In addition, the pharmacological effects of ZP1848 were demonstrated in the 10 Crohn’s disease patients. This was achieved by studying the biomarker citrulline, which is an indicator of the regeneration of mucosal cells and the well-being of the gut. The results showed that there was a clear positive effect on the levels of citrulline in patients treated with ZP1848, compared to patients treated with placebo. The increase in citrulline levels was significant and indicates that ZP1848 has an effect on enhancing epithelial growth, as well as increasing absorptive area and improving gut function. Zealand Pharma is currently preparing a Phase IIa study including endoscopic examinations in Crohn’s disease patients which the Company believes will commence in 2012.

Crohn’s disease, an inflammatory bowel disease (IBD), most commonly affects the last part of the small intestine (the terminal ileum) and parts of the large intestine. However, the disease is not limited to these areas and can affect any part of the digestive tract. Currently available treatments target the symptomatic inflammation associated with IBD whereas ZP1848 works by enhancing the regeneration and healing of the small intestine lining after an inflammatory episode in the gut.

Commenting on today’s announcement, David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are pleased to announce positive Phase I results from this study, which has demonstrated safety and tolerability in healthy volunteers and in Crohn’s disease patients. We are excited that ZP1848 has the potential to provide an alternative treatment paradigm for patients suffering from inflammatory bowel disease."

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Notes for Editors

About Zealand Pharma A/S

Zealand Pharma A/S is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand Pharma is a leader in peptide drug development - a growing market - with significant drug development activities in metabolic (diabetes and obesity), gastro-intestinal and cardiovascular diseases. All of Zealand Pharma’s products target diseases and indications with significant unmet clinical need and commercial potential.

Since 1999, Zealand Pharma’s scientists have built a pipeline that includes five compounds in clinical development, four of which have been out licensed, three of these to major pharmaceutical companies (sanofi-aventis, Wyeth (now part of Pfizer) and Helsinn Healthcare).

All of Zealand Pharma’s compounds emerged fromZealand Pharma’s own drug discovery.

Zealand Pharma A/S is based in Copenhagen. The Company’s investors include, Sunstone Capital, Allianz Private Equity, CDC Innovation, LD Pensions, Dansk Erhvervsinvestering and LSP.

For more information please visit Zealand Pharma’s web site:www.zealandpharma.com.


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Press Release in PDF: http://hugin.info/136974/R/1452117/393059.pdf

 


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(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Zealand Pharma via Thomson Reuters ONE

For further information please contact:


Zealand Pharma A/S

David Solomon

President and Chief Executive Officer

Zealand Pharma A/S

Smedeland 36, DK-2600 Copenhagen, Denmark

Tel: +45 4328 1200

Fax: +45 4328 1212

E-mail: Email Contact


M:Communications

Mary-Jane Elliott / Emma Thompson / Amber Bielecka

Tel: +44(0) 20 7920 2300

E-mail: Email Contact


 

Posted: October 2010

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