Welcome!

Microservices Expo Authors: Pat Romanski, Elizabeth White, Liz McMillan, Stackify Blog, Andreas Grabner

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.

Microservices Articles
In his session at 20th Cloud Expo, Scott Davis, CTO of Embotics, discussed how automation can provide the dynamic management required to cost-effectively deliver microservices and container solutions at scale. He also discussed how flexible automation is the key to effectively bridging and seamlessly coordinating both IT and developer needs for component orchestration across disparate clouds – an increasingly important requirement at today’s multi-cloud enterprise.
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, discussed how to use Kubernetes to set up a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace. H...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
In his session at 20th Cloud Expo, Mike Johnston, an infrastructure engineer at Supergiant.io, will discuss how to use Kubernetes to setup a SaaS infrastructure for your business. Mike Johnston is an infrastructure engineer at Supergiant.io with over 12 years of experience designing, deploying, and maintaining server and workstation infrastructure at all scales. He has experience with brick and mortar data centers as well as cloud providers like Digital Ocean, Amazon Web Services, and Rackspace....
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...