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Pharma Stock Roundup: MRK Buys Cancer Drug Rights, SNY Dupixent Kids Study Succeeds
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This week, Merck (MRK - Free Report) in-licensed co-development rights to Orion Corporation’s prostate cancer candidate. The FDA granted full approval toPfizer’s (PFE - Free Report) COVID-19 vaccine for adolescents aged 12-15 years. Sanofi (SNY - Free Report) and partner Regeneron’s (REGN - Free Report) Dupixent showed the potential to improve signs of eosinophilic esophagitis (EoE) in a phase III pivotal study in children 1 to 11 years of age.
Recap of the Week’s Most Important Stories
FDA’s Full Approval to Pfizer’s Comirnaty for Adolescents: The FDA approved Pfizer/BioNTech’s supplemental biologics license application, which sought full approval for Comirnaty in adolescents aged between 12 years and 15 years. The FDA had previously granted emergency use authorization to the Pfizer/BioNTech vaccine for use in this age group.
Comirnaty currently enjoys full approval for use in individuals aged 16 years and above, granted by the FDA last August. Following this label expansion, Comirnaty is the first and currently the only COVID-19 vaccine to have received full approval for use in individuals aged 12 years and older.
Pfizer/BioNTech submitted a variation to the European Medicines Agency requesting the agency to update the Conditional Marketing Authorization in the European Union for Comirnaty (3-µg dose) to allow its use in children 6 months to less than 5 years of age.
Merck Buys Rights to Co-Develop Orion Corporation’s Prostate Cancer Candidate: Merck signed a licensing deal with Finnish pharmaceutical company, Orion Corporation, for ODM-208, the latter’s investigational steroid synthesis inhibitor in a phase II study for the treatment of metastatic castration-resistant prostate cancer. Merck will make an upfront payment of $290 million to Orion for co-development and co-commercialization rights to ODM-208.The deal also includes an option for Merck to acquire a global exclusive license to ODM-208 compared to the present co-development and co-commercialization agreement.
Sanofi’s Dupixent Meets Goal in Eosinophilic Esophagitis Kids Study: Sanofi and partner Regeneron’s Dupixent showed potential to improve signs of eosinophilic esophagitis in a phase III pivotal study in children 1 to 11 years of age. The study met its primary endpoint of histological disease remission at 16 weeks. In the study, 68% of children given the higher dose of Dupixent and 58% of those on the lower dose achieved the primary endpoint compared to 3% of children on placebo.
Dupixent was approved to treat adults and children aged 12 and older with EoE, a chronic, progressive inflammatory disease, 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 in children under 12 years of age.
The NYSE ARCA Pharmaceutical Index declined 2.0% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: MRK Buys Cancer Drug Rights, SNY Dupixent Kids Study Succeeds
This week, Merck (MRK - Free Report) in-licensed co-development rights to Orion Corporation’s prostate cancer candidate. The FDA granted full approval toPfizer’s (PFE - Free Report) COVID-19 vaccine for adolescents aged 12-15 years. Sanofi (SNY - Free Report) and partner Regeneron’s (REGN - Free Report) Dupixent showed the potential to improve signs of eosinophilic esophagitis (EoE) in a phase III pivotal study in children 1 to 11 years of age.
Recap of the Week’s Most Important Stories
FDA’s Full Approval to Pfizer’s Comirnaty for Adolescents: The FDA approved Pfizer/BioNTech’s supplemental biologics license application, which sought full approval for Comirnaty in adolescents aged between 12 years and 15 years. The FDA had previously granted emergency use authorization to the Pfizer/BioNTech vaccine for use in this age group.
Comirnaty currently enjoys full approval for use in individuals aged 16 years and above, granted by the FDA last August. Following this label expansion, Comirnaty is the first and currently the only COVID-19 vaccine to have received full approval for use in individuals aged 12 years and older.
Pfizer/BioNTech submitted a variation to the European Medicines Agency requesting the agency to update the Conditional Marketing Authorization in the European Union for Comirnaty (3-µg dose) to allow its use in children 6 months to less than 5 years of age.
Merck Buys Rights to Co-Develop Orion Corporation’s Prostate Cancer Candidate: Merck signed a licensing deal with Finnish pharmaceutical company, Orion Corporation, for ODM-208, the latter’s investigational steroid synthesis inhibitor in a phase II study for the treatment of metastatic castration-resistant prostate cancer. Merck will make an upfront payment of $290 million to Orion for co-development and co-commercialization rights to ODM-208.The deal also includes an option for Merck to acquire a global exclusive license to ODM-208 compared to the present co-development and co-commercialization agreement.
Sanofi’s Dupixent Meets Goal in Eosinophilic Esophagitis Kids Study: Sanofi and partner Regeneron’s Dupixent showed potential to improve signs of eosinophilic esophagitis in a phase III pivotal study in children 1 to 11 years of age. The study met its primary endpoint of histological disease remission at 16 weeks. In the study, 68% of children given the higher dose of Dupixent and 58% of those on the lower dose achieved the primary endpoint compared to 3% of children on placebo.
Dupixent was approved to treat adults and children aged 12 and older with EoE, a chronic, progressive inflammatory disease, 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 in children under 12 years of age.
The NYSE ARCA Pharmaceutical Index declined 2.0% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (0.9%) while Pfizer declined the most (3.8%).
In the past six months, Lilly rose the most (33.9%) while Roche declined the most (17.6%).
(See the last pharma stock roundup here: AZN’s Small Cancer Firm Buyout, FDA Updates for PFE, RHHBY)
What's Next in the Pharma World?
Keep a tab on J&J’s Q2 earnings and regular pipeline and regulatory updates next week.