Roche is paying $1.65 billion in confirmed upfront fees to add to its burgeoning obesity pipeline. The outlay, plus up to $3.6 billion in milestones, has secured Roche the right to co-develop and co-commercialize Zealand Pharma’s long-acting amylin analog petrelintide.
Excitement about the potential of amylin assets intensified after Zealand and its rivals shared data at the EASD 2024 meeting in September. The excitement has blossomed into deals in recent days. AbbVie paid $350 million upfront for Gubra’s phase 1 prospect last week. Roche went bigger still Wednesday with its deal for one of the leading assets in the space.
The Swiss drugmaker will pay $1.4 billion when the deal closes and hand Zealand a further $250 million over the first two anniversaries of the collaboration. Zealand is also in line to receive up to $1.2 billion in development milestones, primarily linked to the start of phase 3 trials of petrelintide as a monotherapy. The deal features up to $2.4 billion in sales-based milestones.
Roche and Zealand will share profits and losses equally in the U.S. and Europe. Zealand will receive up to high teens percentage royalties on net sales in the rest of the world. The deal requires Zealand to pay $350 million, offsetable against milestone payments, for a fixed-dose combination of petrelintide and Roche’s GLP-1/GIP receptor agonist CT-388 or next-generation petrelintide combination products.
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Analysts have repeatedly asked Roche about its desire to develop an amylin analog, either internally or via a deal, as interest in the mechanism has built in recent months. Roche entered the obesity space late in 2023 by agreeing to buy Carmot Therapeutics for $2.7 billion. The deal gave the Big Pharma control of a pipeline of oral and injectable obesity assets including CT-388 but didn’t fully sate its appetite.
“We are fully mindful of the fact that [our backbone therapy] needs other combos,” Manu Chakravarthy, M.D., Ph.D., Roche’s global head of cardiovascular, renal, and metabolism product development, said at an EASD event in September. “We're actively looking at all opportunities, external or internal, to ensure that we have the most competitive build of the portfolio that we can.”
Chakravarthy’s list of areas of interest included “amylin, other gut hormones, other things like energy expenditure modulators.” As Roche looked for assets to complement its existing candidates, Zealand shopped petrelintide around to potential partners.
Talking to investors on an earnings call last month, Zealand CEO Adam Steensberg, M.D., said a deal was “probably more likely to happen this year than next year.” The timing would allow a partner to play a role in the design of the phase 3 program and consider investments in manufacturing. Roche is responsible for commercial manufacturing and supply under the terms of the deal.
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Zealand started a phase 2b study of petrelintide in people with overweight or obesity late last year. With enrollment exceeding management’s expectations, the Danish biotech expects to wrap up recruitment by the end of the month.
The primary endpoint is assessing change in body weight from baseline after 28 weeks but the study will remain blinded through 42 weeks. A separate team will review the 28-week data to allow Zealand to talk to regulators and accelerate the move into phase 3 without affecting the integrity of the trial. Zealand is preparing to run a second phase 2b in people with overweight or obesity and type 2 diabetes.
Petrelintide is lagging behind Novo Nordisk’s CagriSema, a combination of the amylin analog cagrilintide and GLP-1 drug semaglutide. Novo is planning to file for approval of the candidate in the first quarter of 2026 but its phase 3 data have disappointed investors. The Danish drugmaker primed investors to expect 25%-plus weight loss and then failed to achieve its self-imposed target.
Zealand has predicted people will lose 15% to 20% of their weight after taking petrelintide as a single agent for one year or more. A combination with CT-388 could drive higher weight loss.
David Kendall, M.D., chief medical officer at Zealand, reiterated the monotherapy target after seeing CagriSema data. Zealand believes petrelintide’s advantages over cagrilintide include the maximum dose and bioavailability.