AstraZeneca 2020: Driven by Covid-19

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Tagrisso

AstraZeneca has been advancing its scientific research, particularly in the area of oncology, in a bid to raise a whole new crop of blockbusters, but the quest for a vaccine against SARS-CoV-2 has made the company shift into a high-speed tangent.

 

 

 

AstraZeneca PLC
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA UK
Telephone: +44 (0)20 3749 5000
Website: astrazeneca.com

 

FINANCIAL PERFORMANCE

(All figures are in millions of dollars, except EPS)

2019

Revenue $24,384 

Net income $1,227 

Diluted EPS $1.03 

R&D expense $6,059 

1H 2020

Revenue $12,629 

Net income $1,488

Diluted EPS $1.17 

R&D expense $2,777 

 

BEST-SELLING Rx PRODUCTS

(All sales are in millions of dollars)

2019

Tagrisso $3,189         

Symbicort $2,495       

Brilinta $1,581     

Farxiga $1,543     

Nexium $1,483    

Imfinzi $1,469            

Pulmicort $1,466     

Crestor $1,278   

Lynparza $1,198       

Faslodex $892     

Zoladex $813            

Toprol-XL/Seloken  $760              

Fasenra $704  

Bydureon $549          

Onglyza $527          

1H 2020

Tagrisso $2,016 

Symbicort $1,442      

Imfinzi $954

Lynparza $951 

Farxiga $850 

Brilinta $845 

Nexium $731 

Crestor  $583 

Zoladex $484 

Pulmicort $477 

 

Outcomes Creativity Index Score: 11
Manny Awards – N/A
Cannes Lions – N/A
LIA: Health & Wellness – N/A
Clio Health – 1
One Show: HW&P – N/A
MM&M Awards – 1
Global Awards – 5
Creative Floor Awards – 4

 

“In the first full year of our return to Product Sales growth, we made good progress in line with our strategy. We anticipate 2020 to be another year of progress,” declared AstraZeneca’s chairman, Leif Johansen, in the beginning of 2020.

“We are now maximizing and exploring the full potential of our leading medicines, rapidly advancing the next wave of science and positioning the company for continued success.” — Pascal Soriot, CEO

CEO Pascal Soriot also expressed optimism about AstraZeneca’s future. “We are now maximizing and exploring the full potential of our leading medicines, rapidly advancing the next wave of science and positioning the company for continued success,” he stated.

And then in February and March came COVID-19. As the pandemic forced country after country to shut down, AstraZeneca, like many other major companies in the pharma industry, had to contend with having a remote workforce and pressure to produce a vaccine against the disease. As results for the first quarter came out, however, Soriot remained positive.

“I could not be prouder of how the AstraZeneca team has responded to the challenges of COVID-19,” he says. “We moved quickly to maintain continuity of care, contribute to society, and use our scientific expertise to fight the pandemic. We hope our efforts to protect organs from damage, mitigate the cytokine storm and the associated hyperinflammatory state, and target the virus prove to be successful.”

The race – and a stumble – for a vaccine

In April, AstraZeneca announced that it had entered a collaboration with Oxford University to produce the university’s recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. 

AstraZeneca is responsible for the worldwide manufacturing and distribution of the vaccine, ChAdOx1 nCoV-19, now known as AZD1222. The vaccine uses a viral vector based on a weakened version of the common cold (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. By May, the vaccine was in a Phase II/III UK trial in about 10,000 adult volunteers.

In June, AstraZeneca reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. “This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval,” Soriot stated. “With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly.”

The company had already reached agreements with the United Kingdom, the United States, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance for 700 million doses, and it agreed to a license with the Serum Institute of India for the supply of an additional 1 billion doses, principally for low- and middle-income countries. AstraZeneca executives say total manufacturing capacity currently stands at 2 billion doses.

As of the end of August, the vaccine was in U.S. Phase III trials, across adults of all age groups. The trial, D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) is participating in the trial.

U.S. trial centers are recruiting up to 30,000 adults aged 18 years and older from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centers outside the United States are included based on predicted transmission rates of the virus and executives states that sites in Peru and Chile are planned to initiate recruitment shortly.

Participants are being randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.

AstraZeneca stated that clinical development of AZD1222 is progressing globally with late-stage clinical trials under way in the UK, Brazil, South Africa, India and Japan with trials planned to start in Russia. These trials, together with the U.S. Phase III program, will enroll up to 50,000 participants globally. Results from the late-stage trials are expected in 2020.

The company ran into some trouble in the progress of the vaccine in September. On September 9, AstraZeneca issued a statement that said, “a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.”

Company executives called it “a routine action, which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

According to news reports, the trial participant was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. Soriot disclosed the details in a private call with investors, reports said. The woman recovered and was discharged from the hospital a few days after the hold was announced.

By September 12, clinical trials had resumed in the United Kingdom, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. As of October 2, the clinical trials had also resumed in Japan, Brazil, South Africa and India while discussions with U.S. authorities continued. 

There has been increasing political pressure, particularly in the United States, to get a vaccine out sooner than later. In September, Soriot and the CEOs of BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna, Novavax, Pfizer and Sanofi signed a pledge vowing to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. The CEOs promised that their companies would always make the safety and well-being of vaccinated individuals their top priority; continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes; only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA; and work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the CEOs said.

In addition to a vaccine, AstraZeneca continues to explore treatments for COVID-19 patients. In August, the company initiated a Phase I trial for AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19. The drug combines two mAbs derived from convalescent patients with SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimized by AstraZeneca with half-life extension and reduced Fc receptor binding. The theory is that the half-life extended mAbs should afford at least six months of protection from COVID-19. In a recent Nature publication, the mAbs were shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.

Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, showed reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease, according to results published in Science Immunology during June. 

Calquence is a next-generation, selective BTK inhibitor approved in the United States for the treatment of certain hematological malignancies. The drug is in a program called CALAVI, comprising two randomized, open-label, multicenter, global trials evaluating the efficacy and safety of Calquence with best supportive care (BSC) versus BSC alone in patients hospitalized with respiratory complications of COVID-19. 

These trials are evaluating the addition of Calquence to current BSC in patients who are hospitalized but not on assisted ventilation. These trials are being conducted around the world: one trial in the United States and one trial outside of the United States, including Europe, Japan and South America. The primary efficacy endpoint measures the number of patients alive and free of respiratory failure following treatment.

Financial results

The company generated total revenue of $24.38 billion in 2019, 10.4 percent more than the previous year. According to management, product sales grew by 12 percent to $23.57 billion, driven by progress in all three of AstraZeneca’s therapy areas: Oncology; Cardiovascular, Renal & Metabolism; and Respiratory. 

“Underpinning our return to growth has been our science-led innovation,” Soriot says. With the launches of Breztri Aerosphere for COPD and Enhertu for breast cancer in 2019, and the launch of roxadustat for anemia in 2020, the total number of new medicines launched since 2013 is 12 as of 2020.

2019 net income was reported at $2.92 billion, 14 percent less than in the previous year. Earnings per share were $1.03, 39.4 percent less than in 2018. 

For the first half of 2020, revenue totaled $12.63 billion, 12 percent more than in the same period of 2019. Net income was $1.49 billion compared with $670 million during first-half 2019. Earnings per share were $1.17 compared with 56 cents in first-half 2019. 

AstraZeneca has five platforms for product sales: Oncology; Emerging Markets; Respiratory; New CVRM (including Brilinta and Diabetes); and Japan. Oncology sales were $8.67 billion in 2019, 44 percent more than in the previous year. 

Emerging Markets sales in 2019 were $8.17 billion, 18 percent more than in 2018. Respiratory sales grew 10 percent to $5.39 billion. Sales in New CVRM increased 9 percent to $4.38 billion. Sales in Japan grew 27 percent to $2.55 billion.

In 2019, the company’s top-selling products with sales of more than $500 million were Tagrisso, Symbicort, Brilinta, Farxiga, Nexium, Imfinzi, Pulmicort, Crestor, Lynparza, Faslodex, Zoladex, Toprol-XL/ Seloken, Fasenra, Bydureon, and Onglyza.

The oncology drug Tagrisso rose to become AstraZeneca’s top-selling product in 2019, generating $3.19 billion, compared with $1.86 billion in 2018. In the first half of 2020, sales grew to $2.02 billion, 43% more than in the same period of 2019. As of the first half of 2020, Tagrisso has received regulatory approval in 86 countries, including the United States, China, in the EU, and Japan for the first-line treatment of patients with EGFRm non-small cell lung cancer. To date, reimbursement has been granted in 28 countries in this setting, with further reimbursement decisions anticipated in the second half of the year. Company executives say this follows Tagrisso’s initial approval in 89 countries, including the United States, China, in the EU, and Japan for the treatment of patients with EGFR T790M35-mutated nonsmall cell lung cancer.

Slipping to No. 2 for 2019 was AstraZeneca’s former top seller, the lung drug Symbicort, which had sales of $2.5 billion, 3 percent less than in 2018. In the first half of 2020, sales were $1.44 billion, 23 percent more than in first-half 2019. An authorized generic version of Symbicort was launched in the United States by the company’s collaborator, Prasco, in January 2020. Management says Symbicort continued its global market-volume and value leadership within the inhaled corticosteroid/long-acting beta agonist (LABA) class. Emerging Markets sales increased by 10 percent in the 2020 first half to $290 million, reflecting particularly strong performances in China and the Middle East and Africa. In Europe, sales increased by 1 percent in the half to $356 million. In Japan, sales rose 53 percent to $102 million, supported by the continued effect of AstraZeneca regaining full rights, following termination in 2019 of the Astellas co-promotion agreement; the increase was despite the market entry of a generic medicine.

The third best-selling product in 2019 was the heart disease and stroke drug Brilinta. The drug generated $1.58 billion, 20 percent more than the previous year. First-half 2020 sales were $845 million, 15 percent more than the first half of 2019. Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction (MI). Emerging Markets sales increased by 34 percent to $291 million. U.S. sales, at $351 million, represented an increase of 9 percent, driven primarily by increasing levels of demand in both hospital and retail settings, as well as a lengthening in the average-weighted duration of treatment, reflecting the growing impact of 90-day prescriptions. In Europe, where the drug is marketed as Brilique, sales increased by 2 percent in the half to $173 million, mainly reflecting performances in Germany, France and Italy.

The fourth best-selling drug in 2019 was Farxiga for diabetes, chronic kidney disease, and heart failure. Sales grew by 11 percent to $1.54 billion. For the first half of 2020, sales came in at $848 million, 17 percent more than in the same period last year. Emerging Markets sales increased by 49 percent to $306 million. In China, Farxiga was admitted to the NRDL with effect from the start of 2020. AstraZeneca says this adversely impacted pricing, but this effect was more than offset by the volume benefit derived from the launch within the NRDL listing. U.S. sales declined by 12 percent to $237 million, reflecting the impact of competitive activity on pricing and the mix of channel sales that outweighed an encouraging level of volume growth. Sales in Europe increased by 25 percent, partly reflecting growth in the class and an acceleration of new-to-brand prescriptions. In Japan, sales to collaborator Ono Pharmaceutical Co. Ltd., which records in-market sales, increased by 14 percent to $43 million.

The fifth best-selling drug for AstraZeneca in 2020 was the proton-pump inhibitor Nexium, which slipped almost 13 percent to $1.48 billion. First-half 2020 sales were $731 million, a decline of 5 percent. Emerging Markets sales of Nexium were stable, increasing by 4 percent at $370 million. In Europe, first-half sales increased by 20 percent to $38 million, while sales in the U.S. declined by 30 percent to $89 million and in Japan, where AstraZeneca collaborates with Daiichi Sankyo, they fell by 5 percent to $204 million.

Coming in at No. 6 in 2019 sales was the cancer drug Imfinzi, which grew to $1.47 billion from $633 million in the previous year. Sales in the first half of 2020 amounted to $954 million, a 51 percent improvement compared with first-half 2019. The drug has received regulatory approval in 62 countries, including the United States, China, in the EU, and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The number of reimbursements increased to 27 in the 2020 first half. During the period, Imfinzi was also approved for the treatment of ES-SCLC patients in eight countries, including the United States. The medicine is already approved for the second-line treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) in 17 countries, including the United States.

The seventh best-selling drug was the asthma product Pulmicort, which generated $1.47 billion in sales in 2019, an increase of 14 percent from the previous year. Growth was driven by Emerging Markets, in which China stood out. Sales in the first half of 2020 were $477 million, a decrease of 33 percent. Sales of Pulmicort, of which the majority were in China, were adversely impacted in the half by the effects of COVID-19. Pulmicort sales in Emerging Markets declined by 36 percent to $371 million in the first half and by 78 percent to $58 million in the second quarter.

Crestor, which was AstraZeneca’s top-selling drug for a number of years before patent expirations took effect, declined to No. 8 in sales in 2019 at $1.28 billion, 11 percent less than the previous year. The cholesterol drug’s sales in the first half of 2020 totaled $583 million, 10 percent less than in first-half 2019. Sales in Emerging Markets declined by 9 percent to $369 million. According to AstraZeneca, the performance was adversely impacted by the effect of volume-based procurement in China. U.S. sales declined by 17 percent to $45 million. In Europe, sales declined by 13 percent to $65 million, while in Japan, where AstraZeneca collaborates with Shionogi Co. Ltd., sales decreased 5 percent to $81 million.

The ninth best-selling drug for the company in 2019 was the oncology product Lynparza, at $1.2 billion compared with $647 million in 2018. Lynparza has received regulatory approval in 75 countries for the treatment of ovarian cancer and has been approved in 67 countries for the treatment of metastatic breast cancer. The product also is approved in 38 countries, including the United States, for the treatment of pancreatic cancer. By the end of the first half of 2020, Lynparza received regulatory approval in the United States for the second-line treatment of HRRm prostate cancer.

In the first six months of 2020, total Lynparza revenue amounted to $951 million, representing growth of 64 percent. Company management says $135 million of Lynparza Collaboration Revenue, reflecting regulatory-milestone receipts, was recorded in the half. The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW).

U.S. sales for Lynparza increased by 55 percent, driven by the launch in the 1st-line BRCAm ovarian cancer setting at the end of 2018. Lynparza continued to be the leading medicine in the poly ADP ribose polymerase (PARP)-inhibitor class, as measured by total prescription volumes in both ovarian and breast cancer. Sales in Europe increased by 51 percent to $198 million, reflecting increasing levels of reimbursement and BRCAm-testing rates, as well as successful recent first-line ovarian cancer launches, including in the UK and Germany.

Japan sales of Lynparza during the 2020 first half amounted to $77 million, representing growth of 32 percent. Emerging Markets sales of $120 million, up by 104 percent, were a result of the regulatory approval of Lynparza as a second-line maintenance treatment of patients with ovarian cancer by the China National Medical Products Administration (NMPA) in 2019. Lynparza was admitted to the China NRDL for the same indication, with effect from January 2020. 

Pushed down to the No. 10 sales rank for 2019 was the oncology drug Faslodex with sales of $892 million, 13 percent less than in 2018. In the first half of 2020, sales declined 40 percent to $312 million. A bright spot during the half was Emerging Markets, with sales increasing 4 percent to $100 million. U.S. sales, however, declined by 87 percent to $34 million, reflecting the launch in 2019 of multiple generic Faslodex medicines. In Europe, where generic competitor medicines are established, sales increased by 6 percent to $116 million, while in Japan, sales declined by 5 percent to $58 million, driven by a mandated price reduction in the second quarter.

Another “legacy” product, the oncology drug Zoladex, placed at No. 11 in 2019 with $813 million, 8 percent more than in 2018. First-half 2020 sales reached $484 million, representing growth of 22 percent. Emerging Markets sales of Zoladex increased by 22 percent to $288 million, which according to AstraZeneca executives reflects increased use and access in prostate cancer. Sales in Europe rose 5 percent to $68 million. In the Established RoW region, sales declined by 7 percent to $81 million, driven by the effects of increased competition.

The 12th top seller in 2019 was another of AstraZeneca’s legacy products, the heart drug Toprol-XL/Seloken. The product generated $760 million, 7 percent more than in 2018. Sales of the product in first-half 2020 were $395 million, about the same as in first-half 2019.

In April 2019, a Louisiana state court granted AstraZeneca’s motion for summary judgment dismissing a state court civil complaint filed by Louisiana’s attorney general. The complaint accused AstraZeneca of engaging in unlawful monopolization and unfair trade practices in connection with enforcement of its patents for Toprol-XL, causing the state government to pay increased prices for the drug. The court entered judgment in AstraZeneca’s favor. The state appealed the ruling. In July 2020, the Louisiana First Court of Appeals reversed the State Court’s ruling and remanded the case to the State Court.

The 13th best-selling drug for AstraZeneca in 2019 was the eosinophilic asthma product Fasenra. The drug had sales of $704 million compared with $297 million in 2018. In first-half 2020, sales grew 44 percent compared with same-period 2019, to $426 million. 

Fasenra has received regulatory approval in 58 countries, including the United States, in the EU, and Japan for treating patients with severe, uncontrolled eosinophilic asthma. 

First-half 2020 U.S. sales for Fasenra increased by 31 percent to $272 million, supported by an increase in the self-administration use as a result of COVID-19 restrictions. Fasenra ended the half as the leading novel biologic medicine in the United States, as measured by new-to-brand prescriptions. In Europe, sales of $88 million in the half represented an increase of 96 percent, reflecting a number of successful launches. Sales in Japan increased by 21 percent to $46 million. In the drug’s approved indication and among new patients, Fasenra obtained the leading market share of all novel biologic medicines in the ‘top-five’ European countries and in Japan. In Emerging Markets, sales amounted to $7 million compared with $1 million in first-half 2019.

AstraZeneca’s 14th best seller in 2019 was the diabetes drug Bydureon. Sales slipped about 6 percent to $549 million. Sales in the first half of 2020 were $216 million, 24 percent less than in the first half of last year. Company executives say U.S. sales of $185 million reflected a decline of 21 percent in the half, resulting from competitive pressures and the impact of managed markets. Patients continue to transition from the dual-chamber pen to the BCise device. Bydureon sales in Europe fell by 29 percent to $24 million. Reflecting the recent and potential performance of Bydureon, a $102 million intangible-asset impairment charge was recorded in the half.

No. 15 in 2019 sales was the diabetes drug Onglyza, with $527 million, a decrease of 3 percent. First-half 2020 sales declined 5 percent to $256 million. Sales in Emerging Markets increased by 15 percent to $100 million, driven by the performance in China. U.S. sales declined 12 percent in the half to $105 million, and Europe sales slipped by 21 percent to $29 million. Management says this highlights the broader trend of a shift away from the DPP-4 inhibitor class, and that given the significant future potential of Farxiga, the company will continue to prioritize commercial support over Onglyza. 

R&D progress

Soriot says 2019 was another exceptional year for AstraZeneca’s science, with the pipeline producing “overwhelmingly positive” news for patients.

“This included a record number of 63 regulatory events, either submissions or approvals for our medicines in major markets,” he stated. “That performance is backed by a healthy pipeline of high potential medicines, with the number of Phase II and Phase III pipeline progressions indicating our ability to deliver longer-term sustainable growth.”

In 2019, the company had 22 pipeline progressions, and an average of 24 progressions in each of the last four years. For 2019, AstraZeneca spent $6.06 billion on R&D, compared to $5.93 billion during 2018. First-half 2020 R&D costs amounted to $2.78 billion versus $2.62 billion for the first six months of 2019.

“We have a range of clinical trials under way investigating the full potential of our marketed medicines and there are plenty more projects in our pipeline,” Soriot says. “Of course, in pushing the boundaries of science, we sometimes experience setbacks which, in 2019, included disappointing results from the Phase III trial of Imfinzi plus tremelimumab in Stage IV non-small cell lung cancer. Overall, however, we continue to make good progress advancing new and exciting candidate medicines designed to change the practice of medicine and ultimately eliminate cancer as a cause of death.”

The company continues to expand indications for already-approved products, especially Imfinzi. In September, Imfinzi was approved in the EU for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy. Imfinzi was also approved in August in Japan for the same indication. The drug is already approved in the United States to treat ES-SCLC.

Also in August, FDA granted Priority Review to Imfinzi for a less-frequent, fixed-dose regimen for treating the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer. If approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500 mg in unresectable Stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer, consistent with the approved dosing in extensive-stage small cell lung cancer.

In July, Tagrisso (osimertinib) was granted Breakthrough Therapy Designation (BTD) by FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The FDA granted the BTD based on data from the Phase III ADAURA trial.

In more clinical news from July, detailed results from the ground-breaking Phase III DAPA-CKD trial showed that Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular or renal death by 39 percent compared to placebo (p<0.0001) in patients with chronic kidney disease Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type 2 diabetes.

In May 2020, Farxiga was approved in the United States to reduce the risk of cardiovascular death and hospitalization for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). With that approval, the drug became the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the FDA indicated to treat patients with HFrEF (LVEF ≤ 40 percent). 

Farxiga is being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomized controlled trial.

In July, Calquence (acalabrutinib) was recommended for marketing authorization in the European Union for the treatment of adult patients with chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults.

One of AstraZeneca’s new pipeline drugs, nirsevimab for the prevention of RSV in preterm infants, had results of a Phase IIb trial published in The New England Journal of Medicine (NEJM). Nirsevimab is an extended half-life RSV mAb developed by AstraZeneca and Sanofi as a passive immunization, with the potential to provide immunity directly to infants and offer immediate RSV protection.

The trial demonstrated for the first time that a single-dose mAb can significantly reduce medically attended RSV LRTI, including bronchiolitis and pneumonia, in infants throughout the full RSV season.

In the Respiratory area, AstraZeneca received good news in July with the U.S. approval of Breztri Aerosphere (budesonide/glycopyrrolate/for the maintenance treatment of patients with chronic obstructive pulmonary disease.

FDA approval was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.

The company’s Cardiovascular portfolio got a boost in June when Brilinta (ticagrelor) was approved in the United States to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease. The FDA approval was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60 mg versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke. The primary composite endpoint was driven by a reduction in heart attack and stroke.

In July AstraZeneca announced that FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, was scheduled for the fourth quarter of 2020.

The sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilinta 90 mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.

Lynparza (olaparib) in July won approval in the European Union for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. The European Commission approval was based on results from the Phase III POLO trial, which were published in the NEJM. Lynparza is approved in the United States and several other countries as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the POLO trial, with ongoing regulatory reviews in other regions.

In May, Lynparza gained U.S. approval for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

In the area of rare diseases, selumetinib was granted orphan drug designation in Japan in July for the treatment of neurofibromatosis type 1 (NF1). Selumetinib is being jointly developed and commercialized with Merck & C0., known as MSD outside the United States and Canada.

 A new round of collaborations

AstraZeneca entered into a new global development and commercialization agreement in July for Daiichi Sankyo’s DS-1062, a proprietary trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) and potential new medicine for treating multiple tumor types.

DS-1062 is in development for the treatment of multiple tumors that commonly express the cell-surface glycoprotein TROP2. Among them, TROP2 is overexpressed in the majority of non-small cell lung cancers and breast cancers, tumor types that have long been a strategic focus for AstraZeneca. This collaboration reflects AstraZeneca’s strategy to invest in antibody drug conjugates as a class, the innovative nature of the technology, and the successful existing collaboration with Daiichi Sankyo.

According to Soriot, “We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2. We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in Oncology. We now have six potential blockbusters in Oncology with more to come in our early and late pipelines.”

Enhertu was granted accelerated approval in December 2019 in the United States for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The drug is a HER2-directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.

In June, AstraZeneca announced a collaboration with Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer. This collaboration focuses on targeting RMPs, proteins that control many aspects of RNA biology and represents a new approach for addressing the process disruptions that can lead to cancer and can cause resistance to medicines. Management says the collaboration combines AstraZeneca’s industry-leading expertise bringing forward novel oncology medicines with Accent’s expertise as a leader in the biology, target identification, and drug discovery of RMP-targeting therapies.

According to José Baselga, executive VP, Oncology R&D, AstraZeneca, “The promise of RMP inhibition is a compelling area of exploration for AstraZeneca. With this collaboration, we will seek to identify novel targets and unlock the full potential of our medicines. We believe that Accent team’s expertise in RNA-modifying protein biology and drug discovery complements AstraZeneca’s extensive research and development portfolio.”