Zealand Pharma A/S
Company Announcement

Zealand Pharma announces that a European regulatory application has been submitted for Lyxumia® (lixisenatide) by its partner Sanofi, as a novel once-daily GLP-1 agonist for Type-2 diabetes

First Zealand Pharma discovered peptide drug now in registration phase, a key corporate milestone achieved

Copenhagen, 2011-11-03 07:42 CET -- Copenhagen, 3 November 2011 – Zealand Pharma (NASDAQ OMX: ZEAL.CO), a Danish biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, announces that its partner Sanofi has submitted a marketing authorization application (MAA) for Lyxumia® (lixisenatide) in Europe. Sanofi announced the news in the company’s Q3 report this morning. Lixisenatide is a once-daily GLP-1 receptor agonist discovered by Zealand Pharma and licensed to Sanofi, which is completing Phase III development of the drug as a new treatment for Type-2 diabetes.

The MAA includes documentation from the extensive international GetGoal Phase III program, comprising data from nine studies and more than 4,300 patients. The GetGoal program provides data to support lixisenatide’s intended use for the treatment of adults with Type-2 diabetes mellitus to achieve glycemic control in patients not adequately controlled on oral anti-diabetics and/or basal insulin; as add-on treatment to metformin; a sulfonylurea or a combination of metformin and a sulfonylurea; or in combination with basal insulin.  

Zealand Pharma’s President and Chief Executive Officer, David Solomon, commented: “The European submission is a major achievement, bringing lixisenatide into the final phase before market launch, and represents a transformational milestone for Zealand Pharma. The GetGoal program has established clinical support for broad use of lixisenatide as a monotherapy and as an add-on to existing treatments, including in combination with basal insulin. We are confident that the drug will quickly find an important role in the management of Type-2 diabetes.”

Results from the GetGoal program support lixisenatide’s efficacy profile with a consistent HbA1c reduction as the primary endpoint, driven by an effective reduction of fasting blood glucose level and by a pronounced post-prandial glucose lowering. As expected from a GLP-1 receptor agonist, a beneficial effect in body weight was observed Lixisenatide once-daily, with a one-step dose increase regimen and a single maintenance dose, was well tolerated and led to significantly improved glycemic control with low risk of hypoglycemia in the overall GetGoal program. Nausea and vomiting, albeit mild and transient, were the most commonly reported adverse events in most studies.

Positive top-line results reported from GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S and GetGoal-F1 are available at Zealand Pharma’s website ir.zealandpharma.com and on www.sanofi.com. Further results from the GetGoal Phase III program are expected to be presented at international conferences during late 2011 and 2012.

Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012.

Financial outlook

Under the agreement with Sanofi, Zealand Pharma is eligible to receive remaining milestone payments of up to USD 235 million covering lixisenatide once-daily formulation, depot formulation and any combination product including lixisenatide. There will be no milestone payment associated with the European submission but there will be a milestone payment relating to the completion of the full GetGoal Phase III program, which is expected in the first quarter of 2012.

 Zealand Pharma is also eligible to low double-digit royalties on worldwide sales of lixisenatide and of any combination product including lixisenatide.

The submission of Lyxumia® in Europe does not change Zealand Pharma’s financial guidance for 2011 of total operational expenses of approximately DKK 170 million (EUR 22.8 million) and of revenues and other operational income of DKK 150 million (EUR 20 million) stemming from the agreement with Boehringer Ingelheim, signed in June 2011.  Zealand Pharma provides no further guidance on revenues.

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For further information, please contact:

David Horn Solomon, President and Chief Executive Officer

Tel: +45 2220 6300

Hanne Leth Hillman, Vice President for IR & Corporate Communication

Tel: +45 5060 3689

About Lyxumia® (lixisenatide)

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was discovered by Zealand Pharma A/S and the global rights are licensed to Sanofi. Lyxumia® is the intended trademark of lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

The GetGoal phase III clinical program provides data for lixisenatide in adults with type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program started in May 2008, includes ten studies and has enrolled more than 4,500 patients.

About Zealand Pharma

Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature and growing clinical pipeline of innovative peptide based drugs. The company’s lead product is Lyxumia® (lixisenatide), a once-daily GLP-1 agonist licensed to Sanofi, which has Lyxumia® in late-stage Phase III development for the treatment of type 2 diabetes. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of diabetes and obesity, and a licence agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the treatment of chemotherapy- and radiotherapy-induced diarrhea.

Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs with favorable therapeutic attributes, and all drug candidates in its pipeline have been identified through the company’s own drug discovery activities. Zealand Pharma’s products target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com.