Welcome!

@DevOpsSummit Authors: Yeshim Deniz, Liz McMillan, Elizabeth White, Zakia Bouachraoui, Pat Romanski

News Feed Item

Phase III program for AVE0010/ZP10 licensed from Zealand Pharma A/S will begin in the first quarter of 2008.

Phase III program for AVE0010/ZP10 licensed from Zealand Pharma A/S will begin in the first quarter of 2008.

COPENHAGEN, DENMARK -- (MARKET WIRE) -- 02/12/08 -- 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).





Copyright © Hugin AS 2008. All rights reserved.

Further information

Zealand Pharma A/S, Smedeland 26 B, DK-2600 Glostrup, Denmark
T: +45 4328 1200
F: +45 43281212
E: [email protected]
www.zp.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@DevOpsSummit Stories
Enterprise architects are increasingly adopting multi-cloud strategies as they seek to utilize existing data center assets, leverage the advantages of cloud computing and avoid cloud vendor lock-in. This requires a globally aware traffic management strategy that can monitor infrastructure health across data centers and end-user experience globally, while responding to control changes and system specification at the speed of today’s DevOps teams. In his session at 20th Cloud Expo, Josh Gray, Chief Architect at Cedexis, covered strategies for orchestrating global traffic achieving the highest-quality end-user experience while spanning multiple clouds and data centers and reacting at the velocity of modern development teams.
Nicolas Fierro is CEO of MIMIR Blockchain Solutions. He is a programmer, technologist, and operations dev who has worked with Ethereum and blockchain since 2014. His knowledge in blockchain dates to when he performed dev ops services to the Ethereum Foundation as one the privileged few developers to work with the original core team in Switzerland.
DXWorldEXPO LLC announced today that Telecom Reseller has been named "Media Sponsor" of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure using the Kublr platform, and how Kubernetes objects, such as persistent volumes, ingress rules, and services, can be used to abstract from the infrastructure.