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Novo plans larger study after encouraging semaglutide results
September 16, 2016 / 6:50 AM / a year ago

Novo plans larger study after encouraging semaglutide results

COPENHAGEN (Reuters) - Novo Nordisk’s experimental injectable diabetes drug semaglutide reduced cardiovascular risk by 26 percent, according to results released on Friday, paving the way for a new and bigger study on the drug’s benefits.

The logo of Danish multinational pharmaceutical company Novo Nordisk is pictured on the facade of a production plant in Chartres, north-central France, April 21, 2016. REUTERS/Guillaume Souvant/Pool/File Photo

Semaglutide is the third diabetes drug to show such heart benefits, after Novo’s Victoza injectable and Eli Lilly and Boehringer Ingelheim’s Jardiance pill.

Novo is already planning a longer study of semaglutide similar to Leader, specifically aimed toward getting a label-claim, Novo’s chief science officer Mads Krogsgaard told Reuters, referring to Novo’s 9,000 patient Victoza study, which lasted five years.

“The idea is to launch the study the moment semaglutide gets approved,” Krogsgaard said.

Semaglutide, which has proved highly effective in reducing glucose levels in patients with type II diabetes, is viewed as a pivotal product for Novo, which competes in the GLP-1 market against several rivals including Eli Lilly’s Trulicity.

“This is a molecule which Novo will examine from every possible angle, also in regards to new disease areas such as liver complications and obesity,” Krogsgaard told Reuters.

Novo’s so-called SUSTAIN 6 study, presented on Friday, showed that semaglutide significantly reduced the risk of heart complications in patients.

Because about half of the deaths in people with diabetes are caused by heart disease, reducing the risk such as heart attacks and strokes is seen as essential.

Novo announced in April that the SUSTAIN 6 trial had significantly cut the risk of major adverse cardiovascular events, but the scale of the benefit was only disclosed this week at a meeting of diabetes experts in Munich.

The study presented of Friday also found that semaglutide caused an “unexpected higher rate” of retinopathy complications, such as blindness.

“But depending on the cause, a large study might ”wash away“ this effect and maybe even show an improvement”, Krogsgaard said.

Semaglutide, which is designed to be given once a week, belongs to a class of medicines known as GLP-1 analogues that increase the body’s insulin production when blood sugar levels are raised.

The excessive blood sugar levels that come with diabetes can cause long-term damage to blood vessels, increasing the risk of heart attack, heart failure or stroke.

Novo intends to file for regulatory approval of semaglutide in the United States and Europe in the final quarter of 2016. Consensus analyst forecasts suggest annual sales could reach $2.2 billion in 2022.

Jefferies predicted an approval decision on semaglutide in the second half of 2017.

Novo Nordisk, which in September presented a new CEO to take over by the beginning of next year, is facing headwinds in the United States, its biggest market, due to tough competition and pricing pressure.

“We expect investor confidence to rise and over time switch away from the current risks of insulin pricing,” Deutsche Bank wrote in a note to clients, predicting instead a new focus on the expansion of the GLP-1 market.

“Semaglutide is one of the drugs which is going to drive growth for Novo Nordisk in the coming years - their entire GLP-1 business in fact,” said Sydbank analyst Soren Lontoft.

The Danish company is also working on an oral version of semaglutide, which would be the first GLP-1 to be given as a pill rather than an injection.

Shares in Novo Nordisk were up 1.9 percent at 310.50 crowns by 0730 GMT.

Editing by Greg Mahlich and Jason Neely

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