Momentum is behind AZ

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United Kingdom

AstraZeneca Plc returned to growth in 2019 with product income of $23.6 billion, up by 12% from a year earlier, and nine drugs achieving sales of $1 billion or more. Pascal Soriot, the chief executive, predicted that 2020 would be another year of progress as new molecules complete clinical development and enter registration.

In the first six months of this year, the company expects to give three data readouts, make five regulatory submissions and receive nine regulatory decisions on new drug candidates. A regulatory decision is expected in Japan on Enhertu, the company’s new antibody-drug conjugate for breast cancer, and decisions are expected in the US for two proposed indications for Lynparza, its PARP inhibitor.

Speaking to journalists on 14 February, Mr Soriot predicted that AstraZeneca would become the world’s fastest growing pharmaceutical company by virtue of its growing portfolio of cancer and respiratory medicines, and drugs to treat cardiovascular and metabolic disorders. This compares with 2012 when the company was in free-fall because of its dependence on legacy drugs which were losing exclusivity.

Total revenue for 2019 was $24.4 billion, up by 10% from a year-earlier. This consisted of the product income and collaboration revenue, which are payments from companies with whom AstraZeneca has partnerships.

Operating profit was $2.9 billion, down by 14% on the basis of International Financial Reporting Standards. This was due to higher spending on the development of Enhertu and an impairment of $533 million following the failure of a Phase 3 trial investigating a new indication for Epanova, an approved lipid-lowering drug. The trial was testing Epanova in patients with mixed dyslipidaemia, but was stopped early for lack of efficacy.

Oncology drugs represented 37% of product sales in 2019 followed by respiratory drugs at 23%, legacy medicines at 22% and cardiovascular, renal and metabolic drugs at 19%. The nine blockbuster medicines were led by Tagrisso, a treatment for lung cancer, Symbicort for asthma and chronic obstructive pulmonary disease and Brilinta for acute coronary syndrome.

In the oncology sector, Enhertu received US Food and Drug Administration approval for breast cancer in late December – a little more than two months from its date of submission. Developed by Daiichi Sankyo Co Ltd with rights licensed to AstraZeneca, the drug consists of a monoclonal antibody linked to a toxin that binds to the HER2 protein on malignant breast cancer cells. It is currently being investigated in at least two other cancer types.

During the 14 February press briefing, the AstraZeneca management team disclosed that the company is exploring new treatment options across the cardiovascular, renal and metabolic therapy areas. As people age, diseases affecting the kidney and heart overlap, which could give rise to new drug discoveries, the executives explained.

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