Novo Nordisk To Establish US Mfg Site for Stem Cell-Based Therapies; Signs Insulin Pen Pacts
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Novo Nordisk plans to establish a manufacturing site in Fremont, California to develop and produce stem cell-based therapies. The company has signed a long-term lease on a GMP facility, previously operated by Asterias Biotherapeutics, a biopharmaceutical company. Separately, the company has also partnered for insulin pens with diabetes technology companies Dexcom, Glooko, and Roche.

The site will support Novo Nordisk’s stem cell-based therapies within Type I diabetes and other chronic diseases. Once operational in 2019, the facility will fulfill the supply of stem cell-based therapies for Novo Nordisk’s clinical trial programs.

In addition to the lease agreement, Novo Nordisk has secured a two-year non-exclusive license on Asterias’ intellectual property relating to stem-cell manufacturing technology. To facilitate collaboration between the two parties and enable Asterias to progress its own clinical programs, Novo Nordisk will sublease laboratory, manufacturing, and office space within the facility back to Asterias until the end of 2021.

The establishment of the production site follows Novo Nordisk’s announcement in May 2018 of an agreement with the University of California San Francisco in which it licensed a technology to enable the generation of GMP-compliant human embryonic stem-cell lines in addition to the rights to develop these into future regenerative medicine therapies. Novo Nordisk also recently established a Stem Cell Transformational Research Unit, based in Måløv, Denmark. The unit oversees multiple partnership projects pursuing stem cell-based treatments for diabetes, Parkinson’s disease, chronic heart failure, and dry age-related macular degeneration. The new production facility will directly support these projects.

In separate news, Novo Nordisk has also partnered with Dexcom, a company developing continuous glucose-monitoring technology, Glooko, a provider of a diabetes-management platform, and Roche for insulin pens. With the partnership, the company says it aims to integrate insulin-dosing data from connected pen devices with its partners’ open ecosystems and diabetes-management services, such as data from continuous glucose-monitoring systems and blood glucose meters.

The launch of Novo Nordisk’s first connected insulin pens, NovoPen 6 and NovoPen Echo Plus, will commence in the first quarter of 2019 and roll out to over 50 countries in the coming years. NovoPen 6 and NovoPen Echo Plus will eventually be phased in to replace NovoPen 5 and NovoPen Echo in countries where those devices are currently available.

Source: Novo Nordisk (stem cell site) and Novo Nordisk (insulin pens)

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