DENMARK — Novo Nordisk has signed a collaboration agreement with Biocorp for the initial commercialization of Mallya, initially in Japan.
Mallya connects directly to Novo Nordisk FlexTouch insulin pens, allowing diabetic patients to automatically collect and record daily insulin injection data such as the number of insulin units, date, and time.
This new agreement strengthens Novo Nordisk and Biocorp’s collaboration on the development of the Mallya product, which was announced in September 2021.
Unlike the first development agreement, which only covered insulin brands, an additional therapeutic area in which Novo Nordisk has a presence was added earlier this year.
The Mallya-linked mobile application allows patients to track their injection history and monitor their treatment in real time, thanks to a mobile application linked to Mallya.
All Novo Nordisk FlexTouch insulin pens are compatible with Mallya. Novo Nordisk will commercialize the smart sensor in Japan beginning in the first half of 2023, according to the latest agreement.
Biocorp recently announced an agreement for the development and global distribution of a specific version of its Mallya smart sensor as an accessory for a drug delivery device manufactured by Merck KGaA.
The agreement expands on their previous collaboration in human growth hormone.
In another recent development, Novo Nordisk announced plans of submitting once-weekly insulin icodec to FDA following Phase III success.
Insulin icodec is a novel once-weekly basal insulin analog that is designed to cover a full week’s worth of basal insulin requirements with a single subcutaneous injection.
Type 2 diabetes currently has no cure, with available treatment options focusing on disease management, such as diet and exercise, diabetes medications, or insulin therapy.
Once-weekly insulin may revolutionize diabetes management. Currently, the longest-lasting basal insulin products are injected once daily.
The capacity for reducing the number of basal insulin injections from at least 365 to just 52 per year implies that once-weekly insulin has the potential to facilitate insulin initiation and improve treatment adherence and persistence in diabetes.
The investigational once-weekly insulin icodec was shown to significantly reduce hemoglobin A1C (HbA1c) without increasing hypoglycemia in people with type 2 diabetes.
With the completion of the icodec trials, Novo can move closer to the hoped-for approval. It plans to file regulatory documents in the United States, the European Union, and China in the first half of 2023.
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