This week, several drugmakers,
Eli Lilly
LLY
,
Merck
MRK
,
Novartis
NVS
and others announced their first-quarter results. The FDA granted priority review status to
AstraZeneca
’s
AZN
regulatory application for pipeline candidate, tremelimumab in liver cancer and approved its rare disease drug, Ultomiris for its third indication.
Pfizer
PFE
filed an application to the FDA seeking emergency authorization for a booster dose of its COVID-19 vaccine in children 5 through 11 years of age and said that it will start the U.S. trial of its gene therapy for Duchenne muscular dystrophy (DMD) after FDA lifted the clinical hold
Recap of the Week’s Most Important Stories
Earnings Update:
Lilly’s first-quarter results were
better than expected
as it beat estimates for both sales and earnings. Other than revenues from its COVID-19 antibodies, Lilly’s sales growth was led by higher demand for drugs like Trulicity, Taltz, Verzenio and others despite pricing pressure. Lilly raised its revenue expectations for 2022 due to higher COVID-19 antibody revenues.
Merck also
beat estimates for both earnings and sales
. Its new oral antiviral medicine, Lagevrio (molnupiravir), generated $3.25 billion in sales and significantly drove the company’s top line. Other than that, increased demand for its cancer drugs and human papillomavirus (“HPV”) vaccines and higher sales of Animal health products boosted overall revenues. Merck’s blockbuster cancer drug, Keytruda generated sales of $4.81 billion in the quarter, up 23% year over year. Merck raised its earnings and sales expectations for 2022.
Novartis
missed estimates for revenues
while beating the same for earnings. Sales in Innovative Medicines rose 4% at constant currency Within this segment, the Pharmaceuticals business unit grew 9%, driven by the strong growth of Entresto and Jakavi. Sales in the Sandoz division rose 8% as business continued to improve from COVID impacts. The company maintained its guidance for sales and core operating income to grow in the mid-single-digit range in 2022.
Lilly’s Tirzepatide Achieves Weight Reduction in Phase III Obesity Study:
Lilly announced that tirzepatide, its dual GIP and GLP-1 receptor agonist, showed “superior weight loss” in the 72-week phase III SURMOUNT-1 study. In the study, treatment with tirzepatide led to up to 22.5% (52 lb or 24 kg) weight loss in obese or overweight adults with at least one comorbidity who do not have diabetes. Moreover, 63% of the participants given tirzepatide 15 mg experienced at least 20% body weight reduction, which was a key secondary endpoint. Tirzepatide is the first drug to achieve more than 20% weight loss on average in a phase III study
FDA Grants Priority Tag to AstraZeneca’s BLA for Tremelimumab in Liver Cancer:
AstraZeneca announced that the FDA has accepted and granted priority review to its biologics license application (BLA) seeking approval for tremelimumab in combination with its cancer drug Imfinzi, for treating patients with unresectable hepatocellular carcinoma (HCC), a form of liver cancer. AstraZeneca will use a priority review voucher for this application, following which the FDA’s decision is expected in the fourth quarter of 2022. Separately a supplemental BLA (sBLA) has also been filed for Imfinzi for expanded use in this indication. The BLA for tremelimumab and sBLA for Imfinzi are based on final data from the HIMALAYA phase III study.
The FDA approved AstraZeneca’s long-acting C5 complement inhibitor, Ultomiris for treating certain adults with generalised myasthenia gravis (gMG), a rare, debilitating, chronic, autoimmune neuromuscular disease. Regulatory applications for Ultomiris for gMG are also under review in Europe and Japan. This is the third indication for Ultomiris, which is also approved for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) in the United States, EU and Japan.
The FDA granted Breakthrough Therapy Designation (BTD) to AstraZeneca and partner Daiichi Sankyo’s drug Enhertu (trastuzumab deruxtecan) for patients with HER2-low metastatic breast cancer in the United States. The BTD was based on pivotal data from the DESTINY-Breast04 phase III study. Enhertu is presently approved for previously treated HER2-positive metastatic breast and HER2-positive metastatic gastric cancer.
Pfizer Seeks Emergency Nod for COVID Boosters in Kids:
Pfizer and partner BioNTech filed an application seeking Emergency Use Authorization (EUA) from the FDA for a booster dose of their COVID-19 vaccine in children 5 through 11 years of age. A booster or “third” dose of the vaccine is now authorized for use in adults and children aged 12 and above. The application was based on data from a phase II/III study, which demonstrated a strong immune response in this age group, following the administration of a booster dose of the COVID vaccine. The two-dose primary series was authorized under EUA for this age group in October 2021.
The European Commission (EC) granted marketing authorization to Pfizer and partner Biohaven Pharmaceutical’s rimegepant, both for acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month. The medicine, which is the first to be approved for both acute and prophylactic treatment of migraine in the EU, will be marketed by the trade name of Vydura.
Pfizer announced that it will open the first U.S. trial sites in a phase III study, CIFFREO, on its mini-dystrophin gene therapy for DMD, fordadistrogene movaparvovec, following the lifting of FDA’s clinical hold on the investigational new drug (IND) application on the candidate. The global CIFFREO study was paused in December last year and the FDA placed a clinical hold on the IND after a fatal serious adverse event occurred in a non-ambulatory participant in the phase Ib study on the candidate. Regulatory authorities in the United Kingdom, Canada, Taiwan, Spain and Belgium have now approved the resumption of the study. Pfizer expects that nearly all CIFFREO sites will open by the end of June 2022. Pfizer has addressed the FDA’s requests related to the potency assay to allow the study to resume in the United States.
Pfizer and partner Valneva announced positive data from a phase II study on their Lyme disease vaccine candidate, VLA15. The data demonstrated the candidate’s strong immunogenicity profile in pediatric participants aged 5-17 years one month after the primary vaccination series. Based on the positive data, the companies decided to include pediatric participants in the phase III study on VLA15, which is expected to be initiated in the third quarter of 2022, subject to regulatory approval.
Novartis Tislelizumab Improves Survival in Phase III Esophageal Cancer Study:
Novartis’ phase III study evaluating pipeline candidate tislelizumab plus chemotherapy for the first-line treatment of advanced esophageal cancer met the primary endpoint in an interim analysis. Data from the study, RATIONALE 306, showed that tislelizumab, an anti-PD-1 immune checkpoint inhibitor, plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in this patient population. Novartis has already filed regulatory applications for tislelizumab for the second-line setting in esophageal cancer
.
Tislelizumab is also under review in Europe for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC.
The NYSE ARCA Pharmaceutical Index declined 0.5% 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, Pfizer rose the most (2.8%) while Roche declined the most (1.6%).
In the past six months, AbbVie rose the most (38.8%) while Roche declined the most (4.1%).
(See the last pharma stock roundup here:
J&J’s Mixed Q1 Results, FDA Updates for GSK and AZN
)
What’s Next in the Pharma World?
Watch for first-quarter results of Pfizer and Novo Nordisk and other regular pipeline and regulatory updates next week.
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