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Novo Nordisk debuts diabetes combo in Mexico

Requires fewer daily injections than current insulin treatment
Novo Nordisk ryzodeg insulin diabetes

Danish pharma company Novo Nordisk has not had the best of times with its diabetes pipeline of late, but chalked up a success with the first launch of its Ryzodeg combination insulin product in Mexico.

Ryzodeg combines the long-acting basal insulin in Novo Nordisk's recently-introduced Tresiba (insulin degludec) product with fast-acting analogue insulin aspart, and is the first combination of these two types of insulin in one pen injector.

The product requires fewer daily injections than administering basal and mealtime insulin in separate injections and provides "an excellent opportunity for intensification of insulin treatment" in people with type 2 diabetes, according to Novo Nordisk's chief science officer Mads Krogsgaard Thomsen.

Tresiba and Ryzodeg were approved in Europe, Japan and several other countries last year, but the company suffered a major knockback after failing to get a green light for either product in the US, which is the largest market for basal insulins in the world.

The FDA turned down Novo Nordisk's marketing application on concerns that the cardiovascular risk profile of Tresiba may not be as good as rival long-acting basal insulin product Lantus (insulin glargine) from Sanofi, although Novo Nordisk insists there is no evidence for that view.

The disappointment was compounded when it was fined 500,000 kroner ($90,000) by the Danish Financial Supervisory Authority last month for delaying disclosure of the US setback to investors.

The company started a cardiovascular safety study - called DEVOTE - to try to answer the FDA's questions about Tresiba and says it hopes to complete enrolment within the next few months. If positive, Novo Nordisk has said it plans to resubmit a marketing application to the FDA for both Tresiba and Ryzodeg in the first half of next year.

The US delay has nevertheless pegged back growth of Tresiba - which was expected to be a major sales driver this year - and prompted Novo Nordisk to start heavily promoting older long-acting insulin analogue Levemir (insulin detemir) to help manage the shortfall.

In the markets where it is available Tresiba is performing well, according to Novo Nordisk's chief executive Lars Rebien Sørensen. For example, in Japan it has 20% market share 18 months after its launch despite competing in the market directly with Lantus and Levemir.

The company recently said it is recruiting patients into DEVOTE more quickly than expected so is hopeful of bringing Tresiba and Ryzodeg to market in the US in early 2016, giving it an opportunity to expand its current 24% market share in the basal insulin market there.

Meanwhile, with Tresiba and Ryzodeg's growth trajectory hampered, Novo Nordisk is now looking to the forthcoming launch of Xultophy/IDegLira (insulin degludec and liraglutide), which has been granted a positive opinion in the EU and could be the first combination of an insulin and GLP-1 receptor agonist to reach the market.

Article by
Phil Taylor

2nd September 2014

From: Sales



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