Roche has partnered with Zealand Pharma to jointly develop and commercialize the latter’s amylin analog, petrelintide, as a standalone therapy and as a fixed-dose combination with Roche’s lead incretin asset CT-388.
Roche will pay $1.65 billion upfront – $1.4 billion upon closing and $250 million over the first two anniversaries of the collaboration. Zealand will also be eligible to receive up to $2.4 billion in milestone-based payments. The deal is expected to close in Q2 this year.
The companies will equally share the profits and losses for petrelintide and petrelintide/CT-388 in the US and Europe, with Zealand receiving “tiered double digit” royalties on net sales in the rest of the world. The deal will also have Zealand pay Roche $350 million, offsetable against milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products.
Following the news, Zealand’s stock was up by 43.2% at market open on 12 March, compared to the market close on the previous day. Roche’s stock was also up by 3.6% at market close on 12 March, compared to market close on the previous day.
Petrelintide development
Petrelintide is a once weekly long-acting amylin analog. Amylin acts as a satiety hormone by signaling a ‘feeling of fullness’ to the brain that results in appetite suppression and the reduction of food intake. It also delays gastric emptying of foods.
In a Phase 1b multiple ascending dose trial, petrelintide demonstrated body weight reductions of up to a mean of 8.6% after 16 weeks, compared to 1.7% seen in the placebo group
Zealand is currently enrolling obese or overweight participants in Phase 2b ZUPREME-1 trial (NCT06662539), with plans to start another Phase IIb ZUPREME-2 study in the first half of 2024. The ZUPREME-2 trial will evaluate petrelintide in overweight or obese participants with type 2 diabetes.
Roche’s obesity pipeline
CT-388 is a once-weekly subcutaneous injectable, dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist being developed for the treatment of obesity and type 2 diabetes. It has a similar mechanism of action as Eli Lilly’s obesity blockbuster drug Zepbound (tirzepatide), which generated $4.9 billion in sales last year.
Last year, Roche reported positive data for CT-388 from a placebo-controlled Phase Ib trial (NCT04838405). Patients in the CT-388 group achieved a mean placebo-adjusted weight loss of 18%. At week 24, 100% of CT-388 treated participants achieved a weight loss of over 5%, 85% achieved more than 10%, 70% achieved over 15%, and 45% achieved 20% weight loss.
Roche acquired CT-388 as part of the $2.7 billion Carmot Therapeutics buy. The company is also evaluating another of the Carmot obesity drugs, CT-988. Last year, Roche reported positive results from the Phase Ib trial (NCT05814107) of its investigational obesity and type 2 diabetes therapy. The once-weekly subcutaneous dual GLP-1 and GIP receptor agonist achieved a placebo-adjusted mean weight loss of -6.1% within four weeks.
Obesity landscape
Obesity treatment space is currently dominated by drugs that target GLP-1. Novo Nordisk’s weight loss drugs, Wegovy (semaglutide) and Saxenda (liraglutide), raked in DKK65.1 billion ($9 billion) in sales last year.
There has been an increased interest in amylin analogues in the obesity treatment space in recent months. Earlier this month, AbbVie signed a $2.2 billion licensing deal with Danish company Gubra for the latter’s obesity treatment, GUB014295.
Novo Nordisk is developing a combination therapy, CargiSema, a combination of cagrilintide, a dual amylin and calcitonin receptor agonist, and semaglutide, a GLP-1 agonist. In December, the company reported data from a Phase III REDEFINE 1 trial showing that the therapy showed a 22.7% weight reduction at 68 weeks.
