Source : 'Scrip Intelligence'
Sales by GlaxoSmithKline plc’s vaccines business declined by 29% in the second quarter of 2020, as COVID-19 pandemic lockdown measures limited visits to physicians but there were initial signs of a recovery in vaccination rates, reported CEO Emma Walmsley as the results were announced on 29 July.
Although GSK is maintaining its 2020 financial guidance (a decline in adjusted EPS of 1% to 4% at constant exchange rates), there remain notable risks to its financial performance, the company said, including the timing of a recovery in vaccination rates, particularly in the US, “which we anticipate in the third quarter.” However, a delay in vaccination rate recovery would significantly impact GSK: “In the case of, for example, a three-month delay, the impact on adjusted EPS would be up to five percentage points,” the company said.
GSK's vaccines sales totaled £1.1bn ($1.4bn) in the second quarter, and overall group sales reached £7.6bn, down by 3% compared with the same period in 2019. Sales of one of the company’s top-selling vaccines, the Shingrix shingles vaccine, declined by 19% to £323m in the second quarter. The company had previously noted it was expecting the pandemic to have some impact on its vaccines business during the second quarter. "GSK Braces For A Hit To Its Vaccines Business Despite A Strong First Quarter" "Scrip"
Still, pediatric vaccination rates at the end of the second quarter appeared to be coming back to pre-COVID levels, with adolescent and adult vaccination rates being “a bit further behind,” Walmsley told a same-day press briefing. She said the company was encouraged by the early signs coming through, with countries putting in place healthcare policies aimed at driving vaccination catch-up programs, “so clearly we are dealing with when, not if,” she remarked.
As one of the major vaccine and vaccine-adjuvant manufacturers globally, GSK is an important part of the pharmaceutical industry’s response to the COVID pandemic, and Walmsley emphasized that GSK did not expect to profit from its COVID vaccine partnerships during the pandemic phase.
“We want to make sure we are investing any short-term returns back into long-term pandemic preparedness, and in donations to the developing world,” Walmsley said. “Clearly, one of the lessons learnt [from COVID-19] is that the industry can contribute significantly to long-term pandemic preparedness. We are invested in our capability and resources around long-term pandemic preparedness, be that the extension of this one, or indeed to be prepared scientifically for new pathogens too.”
GSK has entered into a number of partnerships involving its vaccine adjuvant technology with other companies, and earlier on 29 July the UK-headquartered big pharma and one of its partners, Sanofi, announced they had struck a deal to supply the UK with 60 million doses of their candidate COVID-19 vaccine. Sanofi is leading the development of the recombinant protein vaccine, which is due to enter a Phase I/II study in September. If successful, approval is expected by the companies in the first half of 2021 (see sidebar).
The UK has been badly hit by the COVID-19 epidemic, and the Sanofi/GSK vaccine adds a fourth candidate vaccine to its arsenal. "UK Is First To Sign Up Pfizer For COVID19 Vaccine AstraZeneca For Antibodies" "Scrip"
According to Kate Bingham, chair of the UK government’s vaccine taskforce, the “diversity of vaccine types is important because we do not yet know which, if any, of the different types of vaccine will prove to generate a safe and protective response to COVID-19."
Bingham also warned about being over-optimistic about the successful development of an effective prophylactic vaccine: “Whilst this agreement is very good news, we mustn’t be complacent or over-optimistic. The fact remains we may never get a vaccine and if we do get one, we have to be prepared that it may not be a vaccine which prevents getting the virus, but rather one that reduces symptoms.”
Sanofi and GSK are also discussing supply agreements with the EU and the US, and as two of the world’s leaders in vaccine manufacture, they say that they are expecting to make hundreds of millions of doses available by the end of next year. “We believe more than one vaccine will be needed,” the companies say.
GSK increased its R&D spending on pharmaceuticals by 13% to £922m during the second quarter, and Walmsley highlighted progress with a candidate RSV vaccine, which is expected to advance into Phase III in the second half of this year. Two vaccines will be evaluated in Phase III, one for older adults and the second for maternal adults.
RSV can be a “heavy burden” for older adults, in whom infection can advance to pneumonia, as well as in infants, around 50% of whom contract RSV before they are a year old. The virus is responsible for around 14,000 deaths annually in the US alone, and researchers have been pursuing a vaccine for more than 50 years, the CEO noted.
A Phase III trial of a five-in-one meningitis vaccine is also due to start in the third quarter, and the Phase IIa proof-of-concept OSCAR study of otilimab, a GM-CSF antibody, as a potential treatment for COVID-19 has started in patients with severe pulmonary COVID-19 related disease. Data from the trial are expected in the first half of 2021.
A Phase II/III study of an antibody developed in collaboration with Vir Biotechnology Inc is expected to start in the 2020 third quarter. "AZ and GSK Dip Into Diagnostics To Support COVID19 UK Tests" "Scrip"
Preparations to separate GSK into two companies (pharmaceuticals/vaccines, and consumer health) have made good progress despite COVID, Walmsley noted.
By John Davis