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The program will include over 3,000 diabetic patients and will evaluate a once-a-day injection of AVE0010/ZP10 in combination with the principal existing treatments
COPENHAGEN, Denmark | February 12, 2008 | Today Sanofi-Aventis announced that after consultation with the healthcare authorities, the Phase III program for the GLP-1 agonist AVE0010/ZP10 licensed from Zealand Pharma A/S will begin in the first quarter of 2008.
The program will include over 3,000 diabetic patients and will evaluate a once-a-day injection of AVE0010/ZP10 in combination with the principal existing treatments (metformin, sulfonylurea, insulin), as well as a comparison with exenatide and a monotherapy study.
Filing for approval is expected in 2010. A prolonged release formulation is currently being evaluated in Phase I.
AVE0010/ZP10
AVE0010/ZP10 is a glucagon-like peptide 1, or "GLP-1", receptor agonist developed for subcutaneous injection treatment of Type 2 Diabetes and incorporates Zealand Pharma's "SIP" technology. The compound was licensed to Sanofi-Aventis in 2003.
Endogenous GLP-1 is released from the small intestine in response to food intake and stimulates insulin liberation from the pancreas when blood sugar levels are elevated. In addition, GLP-1 suppresses the production of glucagon (a hormone produced in the pancreas that signals the liver to release stored sugar into the bloodstream) as well as reduces appetite and delays food absorption. GLP -1 only stimulates the release of insulin in case of elevated blood sugar levels but not during periods of normal or low blood sugar. This unique mechanism is associated with a lower risk of hypoglycemia (low blood sugar levels) than conventional antidiabetic drugs.
In the second half of 2007, Sanofi-Aventis successfully completed their double blind, placebo controlled Phase II dose ranging study for AVE0010/ZP10 in 500 Metformin treated patients with Type 2 Diabetes, meeting their primary endpoint of a reduction of the HbA1C levels at the end of treatment.
In line with observations from treatment with AVE0010/ZP10 for up to 28 days, once daily dosing with doses that produced marked lowering of HbA1c during 13 weeks of treatment were associated with low incidence of nausea. In addition, treatment with AVE0010/ZP10 was associated with significant weight loss in obese diabetic patients.
Type 2 Diabetes
Insulin is a naturally occurring, or endogenous, protein that is produced in the pancreas and is essential for uptake of blood sugar into the cells.
In patients with Type 2 Diabetes, often referred to as adult onset diabetes, cells become less sensitive to insulin. Moreover, in late stages of the disease, the pancreas loses the ability to produce sufficient insulin. Type 2 Diabetes is the most common form of diabetes and is caused by both genetic and environmental factors, such as obesity. As a result, the blood sugar is not sufficiently controlled.
If Type 2 Diabetes is not successfully treated, the patient will ultimately develop severe complications such as stroke, heart attacks, heart failure, kidney failure, blindness and disorders in peripheral nerves.
Current medical treatment is capable of controlling blood sugar during the first years after onset of Type 2 Diabetes but as the disease progresses, the existing therapy provides inadequate protection against diabetic complications. Consequently there is a strong need for an alternative treatment of Type 2 Diabetes and AVE0010/ZP10 belongs to the new class of GLP-1 compounds, which are expected to delay the progression of the disease.
According to the International Diabetes Foundation, approximately 246 million people globally had diabetes in 2007. Type 2 Diabetes represents 85-95% of all cases of diabetes in the developed world and an even higher percentage in the developing countries.
About Zealand Pharma
Zealand Pharma is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand is one of the leaders within the peptide area, a growing market with significant drug development activities including treatment of metabolic and cardiovascular diseases. All of Zealand's products target diseases and symptoms of significant unmet clinical need and commercial potential.
Since 1999, Zealand's scientists have built a pipeline that includes five compounds in clinical development, two of which have been out licensed to major pharmaceutical companies (Wyeth and Sanofi-Aventis). All Zealand's compounds emerge from Zealand's own drug discovery.
-- AVE0010/ZP10, a pharmaceutical agent for the treatment of Type 2 Diabetes, has been out-licensed to Sanofi-Aventis (www.sanofi-aventis.com), which is the worlds third largest
pharmaceutical corporation with a strong diabetes franchise.
-- ZP120 is an ORL-1 receptor agonist. Zealand has all the rights to the drug, which is currently in Phase II clinical development.
-- GAP-134/ZP1609; a gap junction modifier that prevents both ventricular and atrial arrhythmias in animal models. With its oral formulation, the molecule represents a novel paradigm for the
potential chronic prevention of cardiac arrhythmias. US based pharmaceutical giant Wyeth Pharmaceutical is currently conducting Phase I trials in the US.
-- ZP1846 is an innovative treatment for prevention of chemotherapy-induced diarrhea, which may prevent discontinuation and dose modification during cancer chemotherapy. Zealand has all
the rights to the drug, and the Company is currently conducting clinical Phase I trials in the US.
-- ZP1848 is a novel paradigm for the treatment of Inflammatory Bowel Diseases (e.g. Crohn's Disease). The compound is in late preclinical development.
In addition, Zealand has a rich and broad portfolio of pre-clinical projects targeting a variety of disease areas, including osteoporosis and obesity-related diabetes.
Zealand Pharma is based in Copenhagen and has approximately 65 employees.
The Company's investors include BankInvest Biomedical Venture, LD Pensions, Dansk Erhvervsinvestering and Sunstone Capital as well as the leading international biotech investors CDC Innovation and AGF Private Equity (both in Paris) and Life Sciences Partners (Amsterdam).
SOURCE: Zealand Pharma
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