Novartis Delivers Strong Second Quarter and 50 Million CureVac Vaccines

 

Novartis reported its second-quarter financials today, with net sales growing 15% to $12.956 billion (U.S.), hitting $25.367 billion for the half-year mark. The company also reported on its COVID-19 vaccine production with CureVac and some changes to its pipeline.

“Novartis delivered a strong second quarter, driven by the momentum of our key growth brands, including Cosentyx, Entresto, Zolgensma, our Oncology portfolio and the launch of Kesimpta which continues to accelerate,” said Vas Narasimhan, chief executive officer of Novartis. “Our pipeline of novel medicines continues to progress with key positive readouts in diseases with high unmet need, including iptacopan in a range of immune mediated diseases, 177Lu-PSMA-617 in prostate cancer and Zolgensma in spinal muscular dystrophy.”

And as is familiar with quarterly and yearly reports, the company reported on a drug in its pipeline it is abandoning. The first was ECF843, which was being developed for moderate-severe dry eye disease (DED). The Phase III data didn’t meet expectations, and the company indicated it was “discontinued in a broad population of moderate to severe DED.” 

ECF843 is a recombinant type of human lubricin and was licensed from Lubris in 2017 for “ophthalmic indications worldwide” except in Europe.

Otherwise, there were a few specific drug updates. Leqvio (inclisiran), received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in December 2020. It was a potential treatment for hyperlipidemia in adults with high low-density lipoprotein cholesterol (LDL-C) who were otherwise on a maximum dose of a statin. The CRL revolved around “unresolved facility inspection-related conditions.” 

The company reported that it had resubmitted and been assigned a PDUFA of January 1, 2022. It’s already approved in Europe. There were no efficacy or safety issues in the CRL.

Novartis said it had submitted asciminib to the FDA for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase in patients who have already been treated with two or more tyrosine kinase inhibitors in addition to patients with T315I mutation. Asciminib is a STAMP inhibitor.

Novartis also has a manufacturing deal with CureVac for CureVac’s COVID-19 vaccine. Novartis’ chief financial officer Harry Kirsch told the media, “We have started the production as planned. We are planning to deliver 50 million doses this year.”

CureVac’s vaccine, CVnCoV, is an mRNA shot, and Novartis is helping manufacturing bulk drug substances at its site in Kundl, Austria.

Last month, CureVac indicated its COVID-19 vaccine was only 48% effective, so there was some question about how much capacity was necessary. Typically, regulators have said a vaccine needed efficacy levels of 50% or higher before authorization. CureVac’s chief executive officer, Franz-Werner Haas, indicated on June 30 that the company planned to submit the vaccine to regulators, especially in the European Union and for age groups that otherwise performed better in the trial than the overall trial population.

“In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the age group of 18 to 60 against hospitalization or death and 77% against moderate and severe disease — an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic and the dynamic variant spread,” Haas stated at the time.

Novartis also helps Pfizer and BioNTech manufacture their COVID-19 mRNA vaccine and indicates it can scale up manufacturing for other companies if needed.

Otherwise, Novartis’ Pharmaceuticals business unit (BU) grew 12% for the quarter, with strong growth from Entresto, Cosentyx and Zolgensma. Kesimspta sales alone hit $66 million (U.S.). The Oncology BU grew 7%, driven by Promacta/Revolade, Jakavi, Kisqali and Tafinlar + Mekinist.

The company’s Sandoz unit expanded by 5%. Innovative Medicines grew 7%. Second-quarter core operating income grew 13%, while operating income grew 41%, primarily from higher sales in addition to divestment gains. Second-quarter net income increased 49%.