ADOCIA : positive phase IIa clinical results on its fast-acting human insulin, HinsBet®

28th of February 2012 - The first clinical results are confirmed on diabetic patients - The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) -

ADOCIA (ISIN: FR0011184241, Ticker: ADOC), a biotechnology company specialized in the formulation of therapeutic proteins for treating diabetes and chronic wounds (diabetic foot ulcers, venous ulcers), announces positive results from a Phase IIa clinical trial evaluating the safety and efficacy of HinsBet®, its fast-acting human insulin, in type 1 diabetic patients. This program is supported by OSEO.

This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.

The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters... [PDF]ADOCIA's Press Release - PDF du communiqué de presse ADOCIA -

Novo Nordisk : Victoza® to be launched in Japan

2 June 2010 - Novo Nordisk announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.

The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza® is officially posted on Japan’s National Health Insurance price list 11 June.

Victoza® is the first GLP-1 to achieve regulatory approval and commercial availability in Japan. It is indicated for the treatment of type 2 diabetes when used as monotherapy or as an add-on to sulphonylurea (SU)... Novo Nordisk's Press Release -

Novo Nordisk Assigns Inhaled Insulin Patent Portfolio to Aradigm

Oct 08, 2008 - Aradigm Corporation (OTCBB:ARDM) ("Aradigm" or "Company"), a specialty pharmaceutical company, announced that Novo Nordisk ("Novo") transferred to Aradigm, at no charge, a portfolio of inhaled insulin related patents pursuant to a license agreement between Aradigm and Novo that was terminated in May 2008. Novo purchased a significant portion of the portfolio from Aradigm in July 2006 and supplemented the portfolio with certain of its own related patents. The portfolio includes both U.S. and foreign patents. Aradigm assumes responsibility for the maintenance of this portfolio.


In addition to the patent portfolio, Novo will transfer to Aradigm a significant preclinical safety database that was developed during the Aradigm/Novo collaboration, the rights to a miniaturized second-generation electronic insulin inhaler and data from Novo's inhaled insulin clinical program, which included nine Phase 3 trials in Type 1 and Type 2 diabetes patients... Aradigm's Press Release -

Emisphere : License Agreement With Novo Nordisk to Develop Oral Formulation of GLP-1 Receptor Agonists for Diabetes

June 23, 2008 - Emisphere Technologies, Inc. (Nasdaq: EMIS) and Novo Nordisk A/S (NYSE: NVO) have entered into an exclusive Development and License Agreement to develop and commercialize oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists, which have the potential of treating Type 2 diabetes, using Emisphere's eligen(R) technology. The agreement includes at least $87 million in product development and sales milestone payments to Emisphere, of which $10 million will be the minimum first year payment, as well as royalties on sales. The agreement also provides Novo Nordisk with the option to develop oral formulations of Novo Nordisk compounds other than GLP-1 receptor agonists using Emisphere's proprietary carrier technology. Further financial details of the agreement were not made public.

Under the new agreement, Novo Nordisk is responsible for the development and commercialization of the product candidates. Novo Nordisk and Emisphere have collaborated since 2007 on early-stage pre-clinical research that has preliminarily confirmed the utility of Emisphere's carriers to provide bioavailable oral formulations of GLP-1 receptor agonists... Emisphere Technologies' Press Release -

Novo Nordisk and Sciele Pharma : FDA Approves PrandiMet, a Replaglinide and Metformin Fixed Dose Combination Tablet for Treatment of Type 2 Diabetes

June 24, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet(TM) (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin(R)) and insulin sensitizer, metformin, for the treatment of type 2 diabetes.
Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet(TM) to physicians in the U.S. Sciele Pharma anticipates that PrandiMet(TM) will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet(TM) has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin... Sciele Pharma's Press Release - Novo Nordisk's Press Release -

Novo Nordisk files for regulatory approval of liraglutide in both the US and Europe

May 23, 2008 - Novo Nordisk announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes. Both the US and the European applications contain documentation from an extensive clinical development programme that included around 6,500 people of which approximately 4,200 received liraglutide. The programme was designed to obtain the indication for use of liraglutide to treat type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with commonly used antidiabetic medications... Novo Nordisk's Press Release -

Aradigm : Data Showing No Occurrence of Primary Lung Cancer in Patients Treated with AERx Insulin Diabetes Management System (iDMS)

April 30, 2008 - Aradigm Corporation (OTCBB:ARDM) announced that review of the clinical data by Novo Nordisk a/s , with whom the Company had a collaboration for inhaled insulin, revealed no occurrence of primary lung cancer in patients inhaling insulin using the AERx(R) insulin Diabetes Management System (iDMS). AERx iDMS uses an aqueous formulation of insulin delivered by a hand-held electronic inhaler. Review of the clinical trial data for AERx iDMS revealed no cases of primary lung cancer either in the 2,307 patients treated with AERx iDMS or in the 1,218 patients treated with comparator treatments... Aradigm's Press Release -

Novo Nordisk : FDA Approves NovoLog for Use in Insulin Pumps by Children and Adolescents

March 18, 2008 - Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration has approved NovoLog® (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients between the ages of 4 and 18 years. NovoLog® is the first and only insulin analog approved for this use.

Data from a trial published in the February issue of Diabetes Care in support of this approval demonstrated that compared to insulin lispro CSII, NovoLog® CSII achieved similar levels of glycemic control and safety. Results came from a 16-week, open-label, multi-center, parallel group study of 298 patients (aspart, n= 198; lispro, n = 100) (aged 4-18 years; type 1 diabetes duration greater than or equal to 1 year; CSII therapy treatment greater than or equal to 3 months; A1C less than or equal to 10% at screening)... Novo Nordisk's press Release -

Novo Nordisk, Liraglutide improves glucose control

Novo Nordisk (20 August 2007) announced clinical results from the second and third of five phase 3 studies with liraglutide - the once-daily human GLP-1 analogue. The two 26-week studies are part of the LEAD® (Liraglutide Effect and Action in Diabetes)... -> click here to read the Novo Nordisk's Press Release. (PDF Version)