It was a relatively quieter week for the pharma sector, barring the earnings reports of Novo Nordisk NVO and Allergan AGN. The FDA approved Sanofi’s SNY Fluzone Quadrivalent flu vaccine for adults 65 years and above and Novartis’ NVS long-acting biosimilar version of Amgen’s febrile neutropenia medicine, Neulasta.
Recap of the Week’s Most Important Stories:
Earnings Update: Allergan reported decent third-quarter results, meeting estimates for earnings while beating the same for sales. Revenues rose 3.6% from the year-ago quarter as higher sales of key products like Botox (cosmetic and therapeutics), Juvéderm collection of fillers, Vraylar, Ozurdex, and Lo Loestrin made up for the loss of exclusivity on some brands and divestitures of some others. It slightly raised its sales guidance for 2019 while maintaining the previously issued earnings view.
Novo Nordisk missed estimates for sales while beating the same for earnings in the third quarter. Sales in the Diabetes and Obesity Care segment increased 5% at constant exchange rate (CER) while that in the Biopharmaceuticals segment increased 6%. Novo Nordisk raised its sales growth expectations from a range of 4-6% at CER to a range of 5-6% at CER.
FDA Approves Sanofi’s Quadrivalent Flu Vaccine for Older Adults: The FDA granted approval to Sanofi’s influenza vaccine, Fluzone High Dose Quadrivalent for use in adults 65 years and above. Fluzone High-Dose is presently marketed as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. The FDA approval of the Fluzone High Dose Quadrivalent vaccine expands protection for an additional influenza B strain. The new quadrivalent vaccine is expected to be available in fall 2020, in time for the 2020-2021 flu season.
Sanofi also presented data from a phase III study (EDITION JUNIOR) evaluating Toujeo (insulin glargine 300 Units/mL) in children and adolescents with type 1 diabetes. The data showed that the group of patients administered Toujeo achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events compared to insulin glargine 100 Units/mL. Meanwhile, the percentage of patients who experienced severe hypoglycemia, and the percentage with hyperglycemia with ketosis were numerically lower with Toujeo.
Sanofi also said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use gave a positive opinion, recommending expansion of Toujeo’s indication in Europe to allow use in adolescents and children based on EDITION JUNIOR study data.
Sandoz Gets FDA Nod for Long-Acting Neulasta Biosimilar: Novartis’ generic subsidiary Sandoz gained FDA approval for Ziextenzo, its long-acting biosimilar version of Amgen’s febrile neutropenia medicine, Neulasta (filgrastim). Sandoz already markets Ziextenzo in Europe as well as a short-acting filgrastim biosimilar, Zarxio, in the United States.
With the approval of Ziextenzo, Sandoz becomes the only company, which offers long- as well as short-acting filgrastim biosimilar treatment options. Sandoz will launch Ziextenzo in the United States this year.
J&J Files for Ebola Vaccine in EU: J&J JNJ submitted a marketing application to the EMA seeking approval for its two-dose investigational Ebola vaccine regimen. J&J has developed the vaccine for the prevention of Ebola Virus caused by Zaire strain.
Novo Nordisk Buys Rights to NASH Candidate: Novo Nordisk obtained an exclusive worldwide license to a potential NASH candidate, UD-014, from Japan’s UBE Industries Ltd for an undisclosed upfront payment. Novo Nordisk will take care of future development/commercialization of UD-014, which is now in pre-clinical studies.
The NYSE ARCA Pharmaceutical Index declined 1.4% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the red except Bristol Myers BMY, which rose 0.4%. AstraZeneca lost the maximum value (4.5%).
In the past six months, AstraZeneca AZN has risen the most (22%) while J&J lost the most (9.1%) mainly due to its litigation issues.
(See the last pharma stock roundup here: MRK, PFE, GSK, BMY Q3 Earnings, Other Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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