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Sanofi (SNY) Dupixent Esophagitis Kids Study Meets Goal
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Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that a phase III pivotal study evaluating their blockbuster medicine, Dupixent, in children 1 to 11 years of age with eosinophilic esophagitis (EoE), met its primary endpoint.
Dupixent was approved to treat adults and children aged 12 and older with EoE in May. Dupixent is the first and only medicine indicated for eosinophilic esophagitis in the United States.
The medicine is, however, not yet approved to treat EoE, a chronic, progressive inflammatory disease in children under 12 years of age.
A chronic, progressive inflammatory disease, EoE inflates and damages the esophagus, which makes it difficult for the patients to eat and swallow, leading to poor quality of life. In children with EoE, the disease causes acid reflux, vomiting, abdominal discomfort and trouble swallowing, which can affect the child’s growth and development. Most children do not respond satisfactorily to unapproved therapies being used to treat them like steroids that can pose serious health risks if used over a long period of time, thus creating the need for proper advanced therapy.
Data from the pivotal pediatric study showed that Dupixent has the potential to improve signs of eosinophilic esophagitis. In the study, 68% of children given the higher dose of Dupixent and 58% of those on the lower dose achieved the primary endpoint of histological disease remission at 16 weeks compared to 3% of children on placebo. In addition to that, the study also showed positive results across a variety of secondary endpoints.
EoE is the fourth disease for which Dupixent is now indicated and also represents the first indication for a gastrointestinal disease. Sanofi and Regeneron’s Dupixent is already approved in the United States, EU and some other countries for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis in different age populations. Dupixent is under review in Europe for EoE.
Sanofi stock has declined 0.6% this year so far against the industry’s increase of 4.3%.
Image Source: Zacks Investment Research
Dupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent sales are now annualizing at close to €6.0 billion after around three years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales. The drug’s frequent label expansion approvals are driving sales higher. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected in the near future, its sales are expected to be higher.
Dupixent has become the key driver of the top line for Sanofi. Dupixent generated first-quarter global product sales of $1.61 billion, which were recorded by Sanofi.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases, driven by type II inflammation like bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis and chronic obstructive pulmonary disease.
Bayer’s stock has risen 6.6% this year so far. Earnings estimates for 2023 have gone up from $2.13 per share to $2.17 per share over the past 90 days.
Earnings of Bayer beat estimates in each of the last four quarters, the average surprise being 17.71%.
Jazz Pharmaceuticals stock is up 20.9% this year so far. Earnings estimates for 2022 have gone up from $16.50 per share to $17.06 per share over the past 90 days, while those for 2023 have increased from $18.04 per share to $18.15 per share.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.81%.
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Sanofi (SNY) Dupixent Esophagitis Kids Study Meets Goal
Sanofi (SNY - Free Report) and partner Regeneron (REGN - Free Report) announced that a phase III pivotal study evaluating their blockbuster medicine, Dupixent, in children 1 to 11 years of age with eosinophilic esophagitis (EoE), met its primary endpoint.
Dupixent was approved to treat adults and children aged 12 and older with EoE in May. Dupixent is the first and only medicine indicated for eosinophilic esophagitis in the United States.
The medicine is, however, not yet approved to treat EoE, a chronic, progressive inflammatory disease in children under 12 years of age.
A chronic, progressive inflammatory disease, EoE inflates and damages the esophagus, which makes it difficult for the patients to eat and swallow, leading to poor quality of life. In children with EoE, the disease causes acid reflux, vomiting, abdominal discomfort and trouble swallowing, which can affect the child’s growth and development. Most children do not respond satisfactorily to unapproved therapies being used to treat them like steroids that can pose serious health risks if used over a long period of time, thus creating the need for proper advanced therapy.
Data from the pivotal pediatric study showed that Dupixent has the potential to improve signs of eosinophilic esophagitis. In the study, 68% of children given the higher dose of Dupixent and 58% of those on the lower dose achieved the primary endpoint of histological disease remission at 16 weeks compared to 3% of children on placebo. In addition to that, the study also showed positive results across a variety of secondary endpoints.
EoE is the fourth disease for which Dupixent is now indicated and also represents the first indication for a gastrointestinal disease. Sanofi and Regeneron’s Dupixent is already approved in the United States, EU and some other countries for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis in different age populations. Dupixent is under review in Europe for EoE.
Sanofi stock has declined 0.6% this year so far against the industry’s increase of 4.3%.
Image Source: Zacks Investment Research
Dupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent sales are now annualizing at close to €6.0 billion after around three years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales. The drug’s frequent label expansion approvals are driving sales higher. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected in the near future, its sales are expected to be higher.
Dupixent has become the key driver of the top line for Sanofi. Dupixent generated first-quarter global product sales of $1.61 billion, which were recorded by Sanofi.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases, driven by type II inflammation like bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis and chronic obstructive pulmonary disease.
Sanofi currently has a Zacks Rank #4 (Sell).
Stocks to Consider
Some better-ranked stocks worth considering are Bayer (BAYRY - Free Report) and Jazz Pharmaceuticals (JAZZ - Free Report) . While Jazz Pharmaceuticals sports a Zacks Rank of 1 (Strong Buy), Bayer has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bayer’s stock has risen 6.6% this year so far. Earnings estimates for 2023 have gone up from $2.13 per share to $2.17 per share over the past 90 days.
Earnings of Bayer beat estimates in each of the last four quarters, the average surprise being 17.71%.
Jazz Pharmaceuticals stock is up 20.9% this year so far. Earnings estimates for 2022 have gone up from $16.50 per share to $17.06 per share over the past 90 days, while those for 2023 have increased from $18.04 per share to $18.15 per share.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.81%.