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This week, Novo Nordisk (NVO - Free Report) raised its previously issued sales and operating profit growth guidance for 2023 due to better-than-expected sales performance of its drugs, Wegovy and Ozempic. Eli Lilly (LLY - Free Report) and Merck (MRK - Free Report) announced pipeline setbacks. AbbVie (ABBV - Free Report) voluntarily withdrew accelerated approvals granted for two blood cancer indications for Imbruvica as the confirmatory studies failed to show favorable outcomes.
Recap of the Week’s Most Important Stories
Novo Nordisk Ups Sales and Operating Profit Growth Outlook: Novo Nordisk raised its sales growth expectations for 2023 from 13-19% at CER to 24-30%. Operating profit growth guidance was upped from 13-19% to 28-34% at CER. Higher sales expectations from the new obesity drug, Wegovy and diabetes medicine, Ozempic propelled the increased outlook. Wegovy sales are expected to be better than previously expected due to improved prescription trends and supply capacity. Accelerated volume growth of the GLP-1 class is expected to result in better sales of Ozempic.
Novo Nordisk announced that it is in-licensing exclusive, worldwide rights from Aspect Biosystems to develop bioprinted tissue therapeutics for treating diabetes and obesity, leveraging the latter’s proprietary bioprinting technology. Per the partnership deal, Novo Nordisk will develop up to four products for the treatment of diabetes and/or obesity. For the deal, Novo Nordisk will make an initial payment of $75 million to Aspect Biosystems. The latter will also be entitled to up to $650 million in future milestone payments for every product arising from the collaboration, plus tiered royalties.
FDA Issues CRL to Lilly’s Mirikizumab BLA: The FDA issued a complete response letter to the biologic license application (BLA) seeking approval of Lilly’s pipeline candidate mirikizumab for treating ulcerative colitis. The FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. Mirikizumab is already approved in Japan.
Merck’s Keytruda+Lenvima Study Failures: Merck and partner Eisai announced that they are discontinuing the phase III LEAP-003 study evaluating a combination of Keytruda and Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma. Per the DMC’s recommendation, Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone.
Merck and Eisai also announced that the phase III LEAP-017 study, evaluating Keytruda plus Lenvima for the treatment of patients with unresectable and metastatic colorectal cancer, did not meet its primary endpoint of OS. Despite witnessing an improvement trend in the final pre-specified analysis of OS, the results failed to meet the criteria for statistical significance, per the pre-specified statistical analysis plan.
The FDA accepted Merck’s supplemental biologics license application (sBLA) seeking approval of Keytruda plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 study. The FDA is expected to give its decision on the sBLA on Dec 16.
AbbVie Withdraws Two Blood Cancer Indications for Imbruvica: AbbVie announced that it is voluntarily withdrawing the accelerated approval granted to its drug Imbruvica for two blood cancer indications in the United States. The indications are mantle cell lymphoma (MCL) for patients who have received at least one prior therapy and those with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Imbruvica was granted accelerated approvals for these indications based on overall response rates observed in phase II clinical studies. The final approval was subject to clinical benefit observed in confirmatory studies. However, the phase III SHINE study in previously untreated MCL and the phase III SELENE study in relapsed or refractory MZL, which served as confirmatory studies, demonstrated poor outcomes for these indications.
Though the SHINE study met its primary endpoint of progression-free survival, it was associated with increased adverse reactions in the Imbruvica plus chemoimmunotherapy arm versus the placebo-controlled arm. The SELENE study failed to meet its primary endpoint of progression-free survival. The above decision will not affect FDA approval for Imbruvica in other indications.
The NYSE ARCA Pharmaceutical Index rose 1.60% in the last five trading sessions.
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, all the stocks were in the green except Pfizer (down 0.1%). AstraZeneca rose the most (3.3%).
In the past six months, AstraZeneca has risen the most (33.1%), while Roche has declined the most (5.3%).
Image: Bigstock
Pharma Stock Roundup: FDA Rejects LLY's Mirikizumab, NVO Ups 2023 Sales & Profit View
This week, Novo Nordisk (NVO - Free Report) raised its previously issued sales and operating profit growth guidance for 2023 due to better-than-expected sales performance of its drugs, Wegovy and Ozempic. Eli Lilly (LLY - Free Report) and Merck (MRK - Free Report) announced pipeline setbacks. AbbVie (ABBV - Free Report) voluntarily withdrew accelerated approvals granted for two blood cancer indications for Imbruvica as the confirmatory studies failed to show favorable outcomes.
Recap of the Week’s Most Important Stories
Novo Nordisk Ups Sales and Operating Profit Growth Outlook: Novo Nordisk raised its sales growth expectations for 2023 from 13-19% at CER to 24-30%. Operating profit growth guidance was upped from 13-19% to 28-34% at CER. Higher sales expectations from the new obesity drug, Wegovy and diabetes medicine, Ozempic propelled the increased outlook. Wegovy sales are expected to be better than previously expected due to improved prescription trends and supply capacity. Accelerated volume growth of the GLP-1 class is expected to result in better sales of Ozempic.
Novo Nordisk announced that it is in-licensing exclusive, worldwide rights from Aspect Biosystems to develop bioprinted tissue therapeutics for treating diabetes and obesity, leveraging the latter’s proprietary bioprinting technology. Per the partnership deal, Novo Nordisk will develop up to four products for the treatment of diabetes and/or obesity. For the deal, Novo Nordisk will make an initial payment of $75 million to Aspect Biosystems. The latter will also be entitled to up to $650 million in future milestone payments for every product arising from the collaboration, plus tiered royalties.
FDA Issues CRL to Lilly’s Mirikizumab BLA: The FDA issued a complete response letter to the biologic license application (BLA) seeking approval of Lilly’s pipeline candidate mirikizumab for treating ulcerative colitis. The FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. Mirikizumab is already approved in Japan.
Merck’s Keytruda+Lenvima Study Failures: Merck and partner Eisai announced that they are discontinuing the phase III LEAP-003 study evaluating a combination of Keytruda and Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma. Per the DMC’s recommendation, Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone.
Merck and Eisai also announced that the phase III LEAP-017 study, evaluating Keytruda plus Lenvima for the treatment of patients with unresectable and metastatic colorectal cancer, did not meet its primary endpoint of OS. Despite witnessing an improvement trend in the final pre-specified analysis of OS, the results failed to meet the criteria for statistical significance, per the pre-specified statistical analysis plan.
The FDA accepted Merck’s supplemental biologics license application (sBLA) seeking approval of Keytruda plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The sBLA is based on data from the KEYNOTE-859 study. The FDA is expected to give its decision on the sBLA on Dec 16.
AbbVie Withdraws Two Blood Cancer Indications for Imbruvica: AbbVie announced that it is voluntarily withdrawing the accelerated approval granted to its drug Imbruvica for two blood cancer indications in the United States. The indications are mantle cell lymphoma (MCL) for patients who have received at least one prior therapy and those with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Imbruvica was granted accelerated approvals for these indications based on overall response rates observed in phase II clinical studies. The final approval was subject to clinical benefit observed in confirmatory studies. However, the phase III SHINE study in previously untreated MCL and the phase III SELENE study in relapsed or refractory MZL, which served as confirmatory studies, demonstrated poor outcomes for these indications.
Though the SHINE study met its primary endpoint of progression-free survival, it was associated with increased adverse reactions in the Imbruvica plus chemoimmunotherapy arm versus the placebo-controlled arm. The SELENE study failed to meet its primary endpoint of progression-free survival. The above decision will not affect FDA approval for Imbruvica in other indications.
The NYSE ARCA Pharmaceutical Index rose 1.60% in the last five trading sessions.
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, all the stocks were in the green except Pfizer (down 0.1%). AstraZeneca rose the most (3.3%).
In the past six months, AstraZeneca has risen the most (33.1%), while Roche has declined the most (5.3%).
(See the last pharma stock roundup here: J&J’s $8.9B Offer for Talc Litigation Settlement & Other Updates)
What's Next in the Pharma World?
Watch out for J&J’s Q1 earnings and regular pipeline and regulatory updates next week.