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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