This week, Pfizer PFE and AstraZeneca AZN announced promising data from early-stage studies on their respective coronavirus vaccine candidates. Separately, Pfizer and its Germany-based partner, BioNTech announced deals with the U.S. and U.K. government to supply their mRNA-based COVID-19 vaccine, if it is successfully developed. Novartis NVS announced mixed results for the second quarter while Roche’s RHHBY sales and profits in the first half of the year were hurt by the coronavirus pandemic.
Recap of the Week’s Most Important Stories
Novartis’ Mixed Q2 Results: Novartis’ sales missed the Zacks Consensus Estimate while earnings beat the same. While earnings rose slightly year over year, sales declined 4% as the first quarter stockpiling benefit reversed in the second quarter. Sales of Lucentis and mature ophthalmology, new patient starts in dermatology, and Sandoz retail were adversely impacted by COVID-19. Sales in the Innovative Medicines division rose 1% while that in the Sandoz division declined 9%. The company tightened its 2020 sales growth guidance.
Meanwhile, Novartis’ phase III study (REACH 3) evaluating Jakavi in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease met its primary endpoint by demonstrating superior overall response rate in such patients compared to best available therapy. The study also met its key secondary endpoints by significantly improving failure-free survival and patient-reported symptoms.
Roche’s Sales Hurt by Coronavirus Pandemic: Roche’s sales in the second quarter of 2020 as well as the first half declined 4%, negatively impacted by the outbreak of COVID-19. Earnings per share came in at CHF 10.44 in the first half of 2020, down from CHF 11.12 in the first half of 2019.
While sales at the Pharmaceuticals division increased 1%, driven by growth in new drugs, Diagnostics division sales climbed 3% driven by COVID-19 testing.
Notably, the company confirmed its 2020 sales growth outlook in low- to mid-single digit range amid the global coronavirus outbreak. Core earnings per share are estimated to rise broadly in line with sales.
Pfizer’s Germany-based Study on Coronavirus Vaccine Impresses: Pfizer/BioNTech announced initial positive data from the phase I/I German study on the most advanced (BNT162b1) of their four experimental mRNA-based vaccines, being evaluated under BioNTech’s BNT162 program, to prevent COVID-19.
The data showed that BNT162b1 vaccine elicited high, dose level-dependent SARS-CoV-2-neutralizing titers after the second dose was administered. Importantly, the data showed that BNT162b1 elicited high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 receptor-binding domain (RBD). The data were very much in line with the early positive data from the I/II U.S. clinical study of BNT162b1, which was announced earlier in July. Overall, the data showed that BNT162b1 can be administered safely, with a manageable tolerability profile. The preliminary data from the U.S. and German studies along with the preclinical data and other clinical data, when available, will be used by the companies to select the lead candidate and dose level for a larger, global phase IIb/III safety and efficacy study that may begin later this month. Pfizer expects to file regulatory applications for a COVID-19 vaccine candidate by October. Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.3 billion doses by the end of 2021.
Pfizer and BioNTech also announced a deal with the U.K. government to supply 30 million doses of their mRNA-based vaccines. The 30 million doses are expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization. Meanwhile, the U.S. government placed an initial order of 100 million doses of BNT162, vaccine for $1.95 billion, if it is successfully developed and gets FDA’s approval or emergency use authorization. Meanwhile, the U.S. government has an option to acquire up to 500 million doses of the vaccine from Pfizer/BioNTech. The U.S. government already has a similar agreement with AstraZeneca/Oxford University to supply up to 300 million doses of their experimental COVID-19 vaccine.
AstraZeneca’s COVID-19 Vaccine Candidate Shows Promise in Early-Stage Study: AstraZeneca announced interim data form a phase I/III study on its COVID-19 vaccine candidate, AZD1222, which it is developing in partnership with Oxford University. In the study, AZD1222 demonstrated robust immune responses against the SARS-CoV-2 virus in all evaluated participants. The data showed that in 95% of participants one month after injection, one dose of AZD1222 led to a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein. The vaccine achieved neutralizing activity in 100% of participants who received a second shot. Meanwhile, AZD1222 induced response of immune T-cells that target the virus, in all participants, peaking by day 14 after injection. Late-stage studies are ongoing in the UK, Brazil and South Africa and are due to start in the United States soon.
Glaxo’s mRNA-Based Deal with CureVac: Glaxo GSK signed a strategic development/commercialization deal with Germany’s CureVac for up to five mRNA-based vaccines and monoclonal antibodies (mAbs) to treat and prevent infectious diseases. Glaxo will also invest £130 million to buy a 10% stake in CureVac in addition to making an upfront payment of £104 million. In addition, CureVac will be entitled to development/regulatory milestone payments up to £606 million as well as tiered royalties on product sales.
Lilly’s Mirikizumab Meets Phase III Plaque Psoriasis Study Goals: Lilly LLY announced that its investigational IL23 inhibitor mirikizumab met the primary and all key secondary endpoints versus placebo at Week 16 in a phase III OASIS-2 study in patients with moderate-to-severe plaque psoriasis. The candidate also met all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the study, including superiority in skin clearance at Week 52.
AbbVie’s Rinvoq Meets Goals in Second Atopic Dermatitis Study: AbbVie ABBV announced that its new rheumatoid arthritis drug, Rinvoq showed significant improvement in skin clearance and itch in a second phase III study (Measure Up 2) evaluating it for moderate-to-severe atopic dermatitis in adults and adolescents. The top-line data showed that both doses of upadacitinib (15 mg and 30 mg) monotherapy met all primary and secondary endpoints versus placebo. The two primary endpoints marked at least a 75% improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) skin at week 16. 60% of the patients given the 15 mg dose and 73% of those administered the 30 mg dose achieved EASI 75 at week 16 versus 13% in the placebo group. Meanwhile 39% and 52% of patients given the 15 mg and 30 mg doses, respectively, achieved vIGA-AD 0/1 versus 5% for placebo. For both doses, patients experienced an early reduction in itch, which was maintained through week 16.
The NYSE ARCA Pharmaceutical Index declined 0.04% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Pfizer recorded the highest increase (7.9%) while AstraZeneca declined the most (3.9%).
In the past six months, Lilly (LLY) has risen the most (16.7%) while Merck and Novartis have declined the most (9.4%).
(See the last pharma stock roundup here: J&J Q1 Earnings, FDA Approvals, Fast Track Tags & More)
What’s Next in the Pharma World?
Watch out for second-quarter earnings of Merck, AbbVie, Pfizer, Lilly, and others and regular pipeline and regulatory updates next week.
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