Even as Novo Nordisk works to steal diabetes market share with its new GLP-1 drug Ozempic, it's advancing an oral version that could pose another threat to rivals in the field. In a new phase 3 study, Novo said oral semaglutide helped patients manage their blood sugar levels better than Eli Lilly and Boehringer Ingelheim's Jardiance.
In the Pioneer-2 trial, Novo's oral semaglutide helped patients reduce HbA1c blood sugar levels by 1.4% at 26 weeks and 1.3% at 52 weeks, both statistically significant over Jardiance's 0.9% at 26 weeks and 0.8% at 52 weeks. Additionally, 72% of patients on oral semaglutide achieved HbA1c levels below 7%, compared with 47% for Jardiance, an SGLT2 drug.
Oral semaglutide's weight loss benefit wasn't statistically significant at 26 weeks—4.2kg compared with Jardiance's 3.8kg—but it was at 52 weeks. At that time point, patients on oral semaglutide saw an average weight loss of 4.7kg, compared with 3.8kg for Jardiance.
Twenty percent of patients experienced mild to moderate nausea on oral semaglutide, according to a note from Credit Suisse analysts. Discontinuations were more frequent on the Novo drug, at 11% compared with 4% for Jardiance.
Taking stock on the results Tuesday, Credit Suisse analyst Vamil Divan wrote that the "overall results are solid." But, he said, "questions around nausea and discontinuation rates" will linger.
Divan also noted that because oral semaglutide needs 52 weeks to differentiate itself on the weight loss benefit against Jardiance, investors may be less enthusiastic about the results. That fact could also provide relief to Eli Lilly investors who may have been worried about the drug, he noted.
Pioneer-2 is one of a series of phase 3 studies testing oral semaglutide against placebo and other diabetes heavy hitters. Novo has already reported Pioneer-1 results. In that study, the drug bested placebo at three dosage strengths at reducing HbA1c blood sugar levels.
Looking ahead, Evercore ISI analyst Umer Raffat noted that the "real question" is how oral semaglutide will fare against another Novo GLP-1 drug, Victoza, in a study called Pioneer-4. Other studies are testing oral semaglutide versus Merck's Januvia and Eli Lilly's Trulicity, according to clinicaltrials.gov.
Novo has said it's expecting a 2019 regulatory filing for oral semaglutide, implying a 2020 launch with approval. The company already has an approval for an injectable version of semaglutide called Ozempic, which is administered once a week. Oral semaglutide would be a daily tablet.
Ozempic already has secured an important formulary position from Express Scripts as Novo launches the drug in the U.S.; analysts have predicted that drug can generate $2.2 billion in sales by 2022.
For the oral version, consensus analyst expectations are $840 million in sales in 2022. The team at Bernstein predicts the oral version can generate about $1.5 billion in 2025.