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Novo Nordisk Alzheimer’s drug trials fail in blow to weight-loss giant

COPENHAGEN (Reuters) – Novo Nordisk’s (NVO) closely following trials of an earlier oral version of its Alzheimer’s drug semaglutide failed to help slow the progression of the brain-wasting disease, the firm said on Monday, a blow to the obesity drug giant that sent its shares tumbling.

The stock was trading almost 10% lower immediately after the market opened.

The trials, which Novo previously called “lottery tickets” to highlight its highly uncertain outcome, tested whether the drug could slow cognitive decline in patients.

Those who fail hope Novo’s Alzheimer’s could open a big new market for GLP-1 drugs like semaglutide; as it faces increasing competition from blockbuster drugs in key therapeutic areas such as obesity and diabetes.

Erik Berg-Johnsen, a portfolio manager at Novo shareholder Storebrand Asset Management, told Reuters that the trial failure was probably the “nail in the coffin” for using their product against Alzheimer’s.

“The fact that the study was stopped after two years, despite plans to extend it to a third year, suggests that semaglutide provides almost no benefit in slowing the progression of Alzheimer’s.”

Novo’s trial was being closely watched as an indication of whether GLP-1 drugs, used by millions of people for diabetes and weight loss, could slow the progression of the disease.

The drug tested was Rybelsus, a pill approved only for type 2 diabetes. Novo’s blockbusters, like Ozempic and Wegovy, contain semaglutide.

Ludovic Helfgott, the company’s Executive Vice President of Product and Portfolio Strategy, described the Alzheimer’s trials as a “lottery ticket” in September, citing huge potential despite uncertain prospects.

Alzheimer’s disease and other dementias affect more than 55 million people worldwide. There is no cure.

“Although semaglutide has not demonstrated efficacy in slowing the progression of Alzheimer’s disease, extensive evidence supporting semaglutide continues to benefit individuals with type 2 diabetes, obesity and related comorbidities,” Chief Scientific Officer Martin Holst Lange said in a statement.

The results from two trials in early-stage patients, called EVOKE and EVOKE+, were another setback for the Danish drugmaker and new CEO Mike Doustdar, who had enjoyed rapid growth under the leadership of Ozempic and Wegovy before slowing sales growth and a falling share price led to a CEO change and mass layoffs.

Injectable drug Ozempic. (AP Photo/David J. Phillip) · RELATED PRESS

The setback reinforces analysts’ doubts about Novo’s Alzheimer’s ambitions; UBS estimates a probability of success of just 10%.

Jyske Bank analyst Henrik Hallengreen Laustsen said the 10% drop in share prices on Monday appeared to be an “overreaction”.

Sydbank analyst Soren Lontoft Hansen said the failure was no surprise for Novo, which has had a difficult year with slowing sales of its key weight-loss drugs, a management overhaul and increased competition from US Eli Lilly (LLY).

“The stock’s reaction is probably driven more by the bad sentiment around Novo Nordisk shares and the negative news flow last year – perhaps there was hope for a bit of a tailwind from this study.”

Biogen’s shares rose nearly 5% premarket following news that Novo’s Alzheimer’s trial had failed. Biogen ( BIIB ) and partner Eisai’s Leqembi and rival Eli Lilly’s Kisunla are the only approved treatments for Alzheimer’s in the United States. Both medications require infusion or injection and can cause significant side effects.

“There were some fears that Ozempic might reduce the opportunity for Leqembi and other Alzheimer’s drugs by preventing disease progression. So these data clear up a potential competitive issue,” Cantor analyst Eric Schmidt said.

The Rybelsus trials, which included a total of 3,808 patients, were the first large trials in patients with early-stage Alzheimer’s.

The trials used a rating system to assess clinical changes in areas such as memory and how well patients were able to take care of themselves over a two-year period. Trial details show that the studies aimed to slow cognitive decline by 20%.

Wall Street analysts rated the trials as high-risk, high-reward and said the data would determine whether Novo’s Alzheimer’s program would be a driver of growth in the future.

(Writing by ‌Stine Jacobsen and Maggie Fick; Editing by Terje Solsvik, Anna Ringstrom and Louise Heavens)

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