Life Science | 2012-02-08
Zealand Pharma announces additional positive results for lixisenatide (Lyxumia®1)) from the global GetGoal Phase III program in Type 2 Diabetes

Top-line results from GetGoal-P, the eighth study in the GetGoal Phase III program to report positive results, show that lixisenatide significantly reduces blood glucose levels (HbA1c)

Copenhagen, 8 February 2012 - Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, announces that Sanofi today in its Full Year 2011 results announcement reported positive top line results from the GetGoal-P Phase III study. GetGoal-P is one of the studies in the global GetGoal Phase III program for lixisenatide, a once-daily investigational GLP-1 agonist for the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to Sanofi.

The GetGoal-P study evaluated the effects of lixisenatide as an add-on therapy to pioglitazone with or without metformin and compared to placebo in patients with Type 2 diabetes. A total of 484 patients received either lixisenatide or placebo.

In the study, lixisenatide achieved its primary efficacy endpoint of significantly reducing blood glucose levels (HbA1c) compared to placebo (p<0.0001) with HbA1c decreasing from a mean baseline value of 8.08% to a mean value of 7.06% (-0.9%) after 24 week in the patient group receiving lixisenatide and from 8.05% to 7.59% (-0.34%) in the placebo group. Safety and tolerability results were consistent with other studies within the GetGoal program. Results from GetGoal-P also showed that symptomatic hypoglycemia rates were low in both groups. Patients randomized to the lixisenatide group had an incidence of symptomatic hypoglycemia at 24 weeks of 3.4% compared to 1.2% in the placebo group. As expected for a GLP-1 agonist, the most frequent adverse event was nausea, with 1.9% of patients discontinuing due to nausea in the lixisenatide arm vs. none in the placebo group. The full study results from the GetGoal-P study are planned for presentation at a future medical congress.

Lixisenatide (Lyxumia®) has delivered positive results throughout the GetGoal Phase III program, which comprises ten completed studies, of which eight have now reported, and has involved more than 4,500 patients with Type 2 diabetes. The results support the efficacy and safety of lixisenatide as a monotherapy, in combination with oral anti-diabetes drugs and in combination with basal insulin.

Commenting on today’s announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said: “The positive results from GetGoal-P is another important milestone in the Phase III clinical development program for lixisenatide, the Zealand Pharma invented diabetes drug. We are pleased to see the consistently supportive results being reported from the GetGoal Phase III program, having led to a regulatory filing for lixisenatide in Europe in November 2011 – and expected to support a planned filing in the US in Q4 2012.”

Sanofi is developing lixisenatide both in a single pen (Lyxumia®), which is now in the registration phase of development, and in a combination pen device with Sanofi’s world leading basal insulin Lantus® (insulin glargine). The commencement of Phase III studies for a combination product using an injection device allowing a variable Lantus® dose with a fixed lixisenatide dose is on track for early 2013.

The agreement with Sanofi

Under the license agreement between Sanofi and Zealand Pharma, Zealand Pharma is eligible to receive additional development and sales milestone payments of up to USD 235 million and low double-digit percentage royalties on global net sales of lixisenatide and any combination product that includes lixisenatide.

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About lixisenatide (Lyxumia®)

Lixisenatide, a glucagon-like peptide-1 (GLP-1) agonist for once-daily dosing, is in development for the treatment of patients with Type 2 diabetes mellitus. Lixisenatide was invented by Zealand Pharma and has been 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 (EASD), the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists and the American College of Endocrinology.

 

About the GetGoal Phase III clinical program

The GetGoal Phase III clinical program provided 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 and enrolled more than 4,500 patients. To date, top-line results have been reported from the GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S, GetGoal-F1, GetGoal-M and Get-Goal-P studies, all supporting potential efficacy and safety for lixisenatide. Further, positive top-line results have been reported from the Phase III GetGoal Duo 1 study (also known as EFC10781*) supporting in particular the efficacy and safety of lixisenatide for use in combination with Lantus® (insulin glargine). Further results are expected in 2012.

* NCT00975286 on www.clinicaltrials.gov

About Zealand Pharma

Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature clinical pipeline of innovative peptide based drugs. The company's lead product is lixisenatide (Lyxumia® ¹⁾), a once-daily GLP-1 agonist for the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to Sanofi. In November, Sanofi submitted a marketing authorization application (MAA) for lixisenatide (Lyxumia®) in Europe and submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012. 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 license agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the treatment of chemotherapy-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.

Note 1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

IT | 2012-01-31
Novaled receives ISO 9001certification

Dresden, Germany, 31st January 2012

Novaled AG has been certified according to the ISO 9001:2008 international quality management standard since January 2012. Working closely with external auditors, the company successfully completed the rigorous procedure certifying Novaled’s effective quality management system.

Novaled, international provider of OLED (organic light-emitting diodes) technologies and materials has passed the DQS certification audit with flying colors. External auditors from DQS GmbH (the German agency in charge of certifying management systems) reviewed all of the company’s quality-related aspects as to compliance with the ISO 9001:2008 international quality management standard over the course of several days. “Novaled AG has demonstrated an effective quality management system with high internal and external quality standards,” noted Thomas John, DQS GmbH auditor. “This is also reflected in the company’s high level of customer satisfaction, a fact we were able to determine during our certification process.”

With the aim of global and comprehensive quality management, the company has already been following the EFQM (European Foundation for Quality Management) Business Excellence Model for many years. The entire Novaled team works continuously toward the highest quality of products, processes and the company as a whole. These efforts led to Novaled being able to successfully demonstrate an extremely high level of quality during an external assessment conducted throughout Europe in January 2011. The company received the “Recognized for Excellence” award with a 5-star rating – an achievement which only few companies are able to reach.

“Global quality is at the center of our company strategy”, says Jana Thiel Novaled quality manager, “This ISO 9001 certification brings an international recognition of our quality standard. Novaled teams are fully committed to reach highest level of excellence “

About Novaled

Novaled AG is an expert in the OLED (Organic Light Emitting Diode) field and specializes in high efficiency long lifetime OLED structures and is an expert in organic electronics. The company is known for its Novaled PIN OLED® technology, its proprietary OLED materials and the customized OLED products and services. Novaled has developed long term partnerships with major OLED producers throughout the world. Based on more than 500 patents granted or pending, Novaled has a strong IP position in the field of OLED technology. Since 2003 the spin off of Technical University (IAPP) and Fraunhofer (IPMS) Dresden is active in the market. Novaled has some 120 staff worldwide with headquarters in Dresden and offices in Korea and Japan. Its main investors include eCAPITAL, Crédit Agricole Private Equity, TechnoStart, TechFund and CDC Innovation. For further details please visit www.novaled.com.

About ISO

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

About DQS

DQS GmbH - an independent and competent management partner for companies of every size and all business sectors - offers objective assessments according to about 100 approved norms and technical or industry-specific standards. DQS GmbH as a part of the worldwide DQS-UL Group is located in Frankfurt/Main and focuses completely on assessments and certifications of management systems and processes.

About EFQM

EFQM, established in 1989, is a global non-for-profit membership foundation based in Brussels with more than 500 members covering some 60 countries and 50 industries. The foundation provides a unique platform for organizations to learn from each other and improve performance. EFQM is the custodian of the EFQM Excellence Model, a proven framework for success that is helping over 30 000 organizations around the globe to strive for sustainable excellence.