Novo Close to Developing Diabetes Tablet


For decades, a substitute for invasive insulin needles -tablets or insulin delivered via inhalable pumps -is seen as a holy grail but scientific endeavours have so far achieved limited success. But, good news for millions of diabetes patients may be in sight. Danish drugmaker Novo Nordisk, a dominant player in the global insulin market, is gearing up for at least two oral products that it believes could give the company a clear breakthrough lead and potentially alter the treatment paradigm.

The company that reaped nearly 80% of its $16 billion sales from various insulin products last year, is hopeful for a regulatory approval for its first time oral therapies, a GLP-1 receptor agonist for type two diabetes and an insulin packed in a tablet form in about three to four years. Once commercially launched, the company said it could see a growth and a visible switch from the used needles.

GLP-1 is a potent hormone that induces beta cells of the pancreas to release insulin in response to rising glucose while controlling the secretion of glucagons.

Speaking to ET, Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk, said the company is on track for an oral longacting diabetes therapy , semaglutide, and hoped to see it in reality around 2020. Novo Nordisk commenced phase-three global clinical studies for the drug last year.In contrast to the existing similar products under development that are likely to be short-acting and need more than a single dose in a day , the oral semaglutide may have an edge with a longer effect accompanied with a superior cardiovascular safety profile.

The injectable form of semaglutide, being developed for once-a-week dose, is expected to be ready for a review by the US FDA later this year, Krogsgaard, who is known among the best in the world for cutting-edge research, told ET at the company's headquarters at Copenhagen earlier this month.

We have come a long way in terms of developing insulins ...We can actually show that semaglutide is better than the currently developed oral drugs and also matches the (benefits) of injectable GLP-1. That means the patients can get the convenience of the tablet and still have the power of a biologic,” Krogsgaard said.

With planned expenditure of $2 billion announced last year, No vo Nordisk is setting up a large oral drugs facility at Clayton in the US for active ingredients, which will be further processed into tablet forms at its Denmark sites. With its near term growth prospects reaching about 6% year on year, the drug maker's excitement is palpable as it sees a multibillion dollar opportunity opening up from that single drug. The drug maker is eyeing a major surge in volumes with its tablets, placing semaglutide next to metformin, which is widely prescribed as a first line of therapy in diabetes patients.

With reference to the possible positioning of the oral semaglutide in the crowded oral diabetes drugs market, Novo Nordisk CEO Lars Rebien Sorensen said, “In my view it would be first after metformin, so it will compete with the whole market of the latest drugs like the DPP-4 and SGLT-2 ... It may be co-administered with SGLT-2 drugs (like Jardiance) but we still need to see the clinical profile and also go through the rigorous regulatory process.”

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