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AstraZeneca: Eyes To The Future

Written by: | chris.truelove@medadnews.com | Dated: Wednesday, October 11th, 2017

 

Although patent expirations continue to depress revenue, AstraZeneca executives believe in the pipeline.

 

AstraZeneca PLC

1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA UK

Telephone: +44 (0)20 3749 5000
Website: astrazeneca.com

 

Best-Selling Products

Product 2016 Sales 2015 Sales
Crestor

$3,401

$5,017

Symbicort $2,989 $3,394
Nexium

$2,032

$2,496

Pulmicort $1,061

$1,014

Brilinta/Brilique $839

$619   

Farxiga $835

$492

Faslodex

$830

$704

Zoladex $816 $816
Toprol-XL/Seloken $737 $710
Seroquel XR

$735

$1,025
Onglyza

$720

$786

Synagis

$677

$662

Bydureon  

$578

$580   

Iressa    

$513

$543  

All sales are in millions of dollars.

 

Financial Performance

  2016 2015
Revenue

$23,002

$24,708

Net income

$3,406

$2,826

Diluted EPS

$2.76

$2.23

R&D expense

$5,890

$5,997

  1H2017 1H2016
Revenue

$10,456

$11,718

Net income $958

$594

Diluted EPS

$0.80

$0.51

R&D expense

$2,802

$2,945

In millions of dollars, except EPS

 

 

According to Pascal Soriot, CEO of AstraZeenca, “2017 should be a turning point in our journey as we bring new medicines to patients across the globe. It is an exciting time as we approach the inflection point for our anticipated return to long-term growth, built on the foundations of a science-led pipeline.”

Soriot contends that despite the challenges the company faces – among them the expiration of patents for its leading selling medicines and getting new drugs approved – “a new AstraZeneca is emerging and its shape is the result of the strategy we announced in March 2013. “

This new AstraZeneca is being built on a pipeline-driven transformation and a focus on three main therapy areas, Soriot says.

“2017 should be a turning point in our journey as we bring new medicines to patients across the globe,” says Pascal Soriot, CEO.

 

“We are focused on returning to growth through a science-led innovation strategy,” he explains. “Our strategic priorities, and the indicators against which we measure our success, are based on investing in three therapy areas, building a strong and balanced portfolio of primary care and specialty care medicines, and accelerating key R&D global commercial presence.”

The first phase in the company’s transformational journey ended in 2015 and was focused on rebuilding the pipeline. According to Soriot, 2016 was a crucial year in the second stage of the journey, as AstraZeneca had to manage a transitional period of patent expirations, drive its growth platforms and roll out new medicines.

“While now largely behind us, the impact of the loss of exclusivity on some of our most important medicines has been significant and will continue in 2017,” Soriot notes.
Between 2011 and 2016, patent expirations reduced product sales in established markets of several brands, such as the statin Crestor, the proton-pump inhibitor Nexium, and the antipsychotic Seroquel, from $20 billion to $6 billion. Executives say unfavorable currency movements accounted for $2 billion of this $14 billion reduction.

“This decline represents a significant ‘headwind’, but we have made significant progress rebuilding our company for the future and preparing for a new period of growth driven by our pipeline delivery,” Soriot says.

 

Financial Results & Product Sales

In 2016, AstraZeneca recorded revenue of $23 billion, 6.9 percent less than in 2015. Executives attributed the decrease to the ongoing impact of patent expirations, particularly the statin Crestor in the United States.

In 2016, U.S. revenue was down 22 percent to $7.37 billion; Europe decreased 5 percent to $5.06 billion; and Established ROW rose by 2 percent to $3.1 billion.

Revenue during the first six months of 2017 amounted to $10.46 billion, 10.8 percent less than in the first half of the previous year. Soriot says the performance was “in line with expectations as we experience the loss of exclusivity of Crestor and Seroquel XR in the U.S.”

Reported post-tax profit for 2016 amounted to $3.41 billion, an increase of 21 percent (CER: increase of 6 percent). Reported basic EPS of $2.77 for 2016 represented growth of 24 percent (CER: growth of 9 percent), partly reflecting the revaluation of acquisition-related liabilities. Diluted earnings per share in 2016 came to $2.76 compared to $2.23 for the 2015 calendar term.

For the first half of 2017, profit after tax amounted to $958 million compared to $594 million during January-June 2016. Diluted earnings per share were 80 cents compared with 51 cents in first-half 2016.

For 2016, the company spent $5.89 billion for R&D, 1.8 percent less than in 2015. First-half 2017 R&D costs were $2.8 billion, 4.9 percent less than in the first half of 2016.

AstraZeneca’s top-selling products in 2016 with sales of more than $500 million were Crestor, Symbicort, Nexium, Pulmicort, Brilinta, Farxiga, Faslodex, Zoladex, Toprol-XL/Seloken, Seroquel XR, Onglyza, Synagis, Bydureon, and Iressa.

Despite the product’s patent expirations, the statin Crestor remained AstraZeneca’s top-selling medicine in 2016. However, sales declined from $5.02 billion to $3.4 billion. First-half 2017 sales continued to fall, to $1.19 billion, 43 percent less than during first-half 2016.

Crestor sales in 2016 were $3.4 billion compared with $5 billion 2015.

 

The respiratory drug Symbicort, the second best-seller in 2016, generated $2.99 billion, 11.9 percent less year over year. In the first half of 2017, sales were $1.38 billion, 11 percent less than during the same period of 2016.

In January 2017, AstraZeneca announced that U.S. Food and Drug Administration was granted six months of pediatric exclusivity for Symbicort. The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged 6 up to 12 years in response to a Written Request. Symbicort is approved in the United States to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

No. 3 in sales was the proton-pump inhibitor Nexium, at $2.03 billion, a decline of 18.6 percent from 2015. For the first half of 2017, Nexium sales were $1.06 billion, 3 percent more than in first-half 2016.

The fourth best-selling drug in 2016 was the respiratory drug Pulmicort, at $1.06 billion, a modest 4.6 percent increase from 2015. First-half 2017 sales were $563 million, 3 percent more than in the first half of 2016.

No. 5 in 2016 sales was the heart drug Brilinta, which is one of AstraZeneca’s six focused growth platforms. The drug generated sales of $839 million compared with $619 million in 2015. First-half 2017 sales were reported at $496 million, an increase of 26 percent compared with first-half 2016.

The diabetes drug Farxiga was the sixth best-selling drug in 2016, at $835 million compared with $492 million in 2015. In the first half of 2017, sales of the drug were $457 million, 22 percent more than in the same period last year.

No. 7 in 2016 sales was the oncology drug Faslodex, which generated $830 million, a 17.9 percent increase from 2015. First-half 2017 sales were $462 million, 15 percent more than in first-half 2016.

The eighth best-selling drug in 2016 was another oncology drug, Zoladex. Sales of $816 million were unchanged from 2015. During the first half of 2017 sales declined 5 percent compared with first-half 2016, to $363 million.

AstraZeneca’s ninth top seller in 2016 was another of its “legacy” products, the heart drug Toprol-XL/Seloken, at $737 million, 3.8 percent more than in 2015. Sales of the product in first-half 2017 declined 3 percent when compared with the same period in 2016, to $367 million.

No. 10 for the company in 2016 was the antipsychotic Seroquel XR. Patent expiration continued to affect the product’s sales, which declined 28.4 percent from 2015 to $735 million. First-half 2017 sales were $162 million, 62 percent less than in the first half of 2016.

No. 11 in sales for 2016 was the diabetes drug Onglyza, at $720 million, 8.4 percent less than in 2015. Sales of the product for the first half of 2017 were $304 million, 24 percent less than in first-half 2016.

The company’s 12th best-selling drug in 2016 was the RSV disease preventative Synagis. The drug achieved sales of $677 million, 8.8 percent more than in 2015. In the first half of 2017, sales were $300 million, 11 percent more than during the same period last year.

No. 13 for AstraZeneca in 2016 was the diabetes drug Bydureon, which generated $578 million, about the same as in 2015. First-half 2017 sales of $299 million were 3 percent more than those in first-half 2016.

Coming in at No. 14 was the lung cancer medicine Iressa with $513 million in sales, 5.5 percent less than the total generated during 2015. For the first half of this year, sales of $263 million were 3 percent less than in the first half of 2016.

In addressing the future and to offset patent expirations, AstraZeneca had created six focused growth platforms: Brilinta/Brilique; Diabetes; Respiratory; New Oncology; Japan; and Emerging Markets.

The company is working to deliver Brilinta/Brilique’s potential to reduce cardiovascular deaths through ongoing clinical studies. For the Diabetes growth platform, AstraZeneca worked to maximize the potential of its non-insulin, anti-diabetic portfolio to transform patient care, executives say.

In January 2017, the company reduced its number of growth platforms to five with the creation of CVDM, which combines the Diabetes franchise, Brilinta/Brilique, and any new launches.

“Our new specialty care portfolio is expected to balance our strength in primary care medicines,” executives say. “The diabetes drug Farxiga/Forxiga is a global leader in the SGLT2 class of diabetes treatments with a 35 percent volume share. Product sales of Brilinta/Brilique reached $839 million and in many countries it is the leading medicine for patients discharged with acute coronary syndrome.”

For the Respiratory platform, AstraZeneca is working to maximize pipeline value, devices and medicines to improve patient outcomes in asthma and COPD.

In Oncology, AstraZeneca is aiming to deliver six new cancer medicines to patients by 2020. The platform includes the PARP inhibitor Lynparza; Iressa in the United States; and the non-small cell lung cancer drug Tagrisso.

For the Japan platform, company management plans to strengthen AstraZeneca’s Oncology franchise in that country and work to maximize the success of its Diabetes medicines and the established brands Symbicort, the proton-pump inhibitor Nexium, and Crestor.

Crestor sales in 2016 were $3.4 billion compared with $5 billion 2015.

 

In Emerging Markets, the company’s focus is on delivering innovative medicines by investing in that market’s capabilities, with a focus on China and other leading markets.

 

New R&D Center & Pipeline Progress

“As we look ahead to 2017 and beyond, continued investment in our pipeline keeps us on track to return to sustainable growth in line with our targets,” Soriot says.

One of the company’s most significant investments is its Cambridge, United Kingdom, R&D center. Cambridge, along with Gaithersburg, Maryland, and Gothenburg in Sweden, is one of the company’s three strategic R&D centers, and also became AstraZeneca’s global corporate headquarters in May 2016.

“Our activities there demonstrate our focus on science, collaborative way of working and commitment to sustainability,” Soriot says.

In April, AstraZeneca marked a key milestone in its move to Cambridge with the “topping out” of its R&D center and global corporate headquarters. Occupation of the site will begin in stages in 2018.

Executives say the “topping out” milestone represents the completion of the new building’s concrete frame, as the focus of construction work now turns to installing the roof, external glass cladding and starting the internal fit out. The building has been co-designed by the company’s scientists and world-leading architects Herzog & de Meuron with the open architecture reflecting AstraZeneca’s collaborative approach to research. “Open laboratories and transparent glass walls will enable new ways of working across disciplines and with external partners, whilst a central courtyard, open to the public, will put science on full display,” executives say.

The new R&D site will become AstraZeneca’s largest center globally for oncology research, as well as housing scientists focused on respiratory, cardiovascular, and metabolic diseases. According to Mene Pangalos, executive VP of AstraZeneca’s Innovative Medicines and Early Development Biotech Unit and Business Development, “We believe that the best way to meet today’s scientific challenges is to work in an open, transparent and collaborative way with the world’s best scientists – both inside and outside AstraZeneca – so Cambridge is the perfect home for our new strategic R&D hub.”

According to executives, biologics now account for about half of AstraZeneca’s NMEs in development, potentially enhancing asset longevity.
Some of the most exciting science being undertaken at the company is in Oncology, Soriot says, adding that 2016 was a significant year for the Oncology team, with four regional approvals, seven expedited reviews, and seven regulatory submissions. “Looking ahead, we have the potential to deliver our third Oncology medicine in 2017 – halfway to our 2020 target in just four years.”

In March 2017, Tagrisso (osimertinib) received full approval in the United States, converted from accelerated approval. The drug is approved for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso is the first approved medicine in the United States indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

According to Sean Bohen, executive VP, Global Medicines Development and chief medical officer at AstraZeneca, “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition. The FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy.”

The full U.S. approval is based on data from the randomized, Phase III AURA3 trial, in which Tagrisso significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median PFS compared to 4.4 months from chemotherapy (hazard ratio 0.30; 70 percent risk reduction; 95 percent Confidence Interval [CI]: 0.23; 0.41; P<0.001). The results of this trial were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, and published in The New England Journal of Medicine.

Tagrisso was granted Fast Track, Breakthrough Therapy and Priority Review designations by the U.S. FDA, and received Accelerated Approval for this indication in 2015 based on tumor response rate and duration of response.

The full U.S. approval is in addition to other approvals Tagrisso has received. The drug was approved in China during March 2017 as a first-in-class treatment for EGFR T790M mutation-positive metastatic non-small cell lung cancer, becoming the first AstraZeneca medicine approved under China’s new Priority Review pathway

Executives say Tagrisso is an important new medicine in a country where lung cancer is the leading cause of cancer-related deaths and EGFR-mutation rates are among highest globally. Approximately 30 percent to 40 percent of Asian patients with NSCLC have the EGFR mutation at diagnosis, and nearly two thirds of these patients whose disease progresses after treatment with an EGFR TKI develop the T790M mutation.

Dr. Bohen called the China approval “an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients with NSCLC in China, where EGFR mutation rates are some of the highest in the world.”

Eligibility for treatment with Tagrisso requires the patient’s EGFR T790M mutation status to be determined with a validated test using either tumor DNA derived from a tissue sample or circulating tumor DNA (ctDNA) obtained from a plasma sample (blood test).

Tagrisso is the first AstraZeneca medicine approved under the CFDA’s Priority Review pathway, using an accelerated timeline for an innovative medicine. The rapid review and approval signal the urgent need for new, targeted treatments with the potential to address specific types of cancer with high incidence rate and significant unmet medical need in China. They are also a recognition by the CFDA of the accelerated reform of China’s regulatory framework to benefit Chinese patients.

In September, AstraZeneca released the presentation of the full results of the Phase III FLAURA trial, which executives say support Tagrisso’s clear potential as a new standard of care in the first-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. According to the company, they demonstrate a superior, clinically meaningful progression free survival advantage with Tagrisso compared with the current standard of care for EGFR-TKIs, which is erlotinib or gefitinib.

Tagrisso 40mg and 80mg once-daily tablets received full marketing authorization in April from the European Commission for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). The full approval for Tagrisso is based on the results of the Phase III AURA3 trial.

In August 2017, Faslodex (fulvestrant) received FDA approval as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. The drug showed a 20 percent reduction in disease progression versus anastrozole, a current standard treatment option. The expanded approval provides earlier benefit for advanced breast cancer patients not previously treated with endocrine therapy.

The FDA approval is based on data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet.

Another Oncology victory during 2017 for AstraZeneca occurred in May when Imfinzi (durvalumab) received FDA accelerated approval for treating patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Imfinzi is approved under the FDA’s accelerated approval pathway, based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Imfinzi is also under investigation in the Phase III DANUBE trial as first-line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab. The product in July 2017 was granted Breakthrough Therapy Designation by FDA for the treatment of patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.

However, also during July, AstraZeneca reported results from the Phase III MYSTIC clinical trial that demonstrated neither Imfinzi nor a combination of Imfinzi and tremelimumab met the primary endpoint of improving progression-free survival compared to the platinum-based chemotherapy in patients whose tumors express PD-L1 on 25 percent or more of their cancer cells. The trial will continue to assess two additional primary endpoints of overall survival for Imfinzi monotherapy and overall survival for the Imfinzi plus tremelimumab combination. Final overall survival data from both primary endpoints are expected during the first half of 2018.

During August 2017, AstraZeneca and Merck & Co. (see profile on page 51) announced that FDA granted approval for the PARP inhibitor Lynparza (olaparib) as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube, or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status; and for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

In 2016, AstraZeneca’s Cardiovascular & Metabolic Disease (CVMD) team saw three approvals, four regulatory submissions, and two Brilinta trials that failed to meet their primary endpoints.

However, in August 2017 AstraZeneca reported results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29 percent risk reduction in cardiovascular death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death.

In the trial, patients received Brilinta within two years of having a heart attack (myocardial infarction, MI) or within one year of stopping anti-platelet treatment with an adenosine diphosphate (ADP) inhibitor. AstraZeneca executives say the latest results highlight a potential protective CV benefit associated with longer-term treatment, versus the standard 12-month post-event treatment period, with Brilinta 60mg. The results were to be presented in full at the ESC Congress in Barcelona, Spain.

In 2016, AstraZeneca received a complete response letter from the FDA for ZS-9 for the treatment of hyperkalemia and subsequently made a resubmission. In March 2017, AstraZeneca received another complete response letter for ZS-9 (sodium zirconium cyclosilicate). The product is being developed by ZS Pharma, a wholly owned subsidiary of AstraZeneca.

The March letter followed an inspection by the FDA of the ZS-9 manufacturing facility. Executives say the CRL does not require the generation of any new clinical data.

“AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible,” executives say.

In February 2017, sodium zirconium cyclosilicate received a positive opinion by the Committee for Medicinal Products for Human Use in the European Union.

In August 2017, AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, announced that FDA accepted and granted Priority Review for the New Drug Application for acalabrutinib, a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor.

The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. This follows the FDA’s recent Breakthrough Therapy Designation for acalabrutinib.

In the Diabetes area during 2016, AstraZeneca received positive results from the company’s DURATION-8 trials, which demonstrated the efficacy of Farxiga (dapagliflozin) and Bydureon (exenatide) in combination for the treatment of type 2 diabetes

In February 2017, FDA approved another combination of dapagliflozin as once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type 2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar level) control in adults with Type 2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.

According to Elisabeth Björk, VP, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, “The approval of Qtern is good news for patients who may benefit from improved glycemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet.”

SGLT-2 inhibitors such as Farxiga help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. These drugs have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors such as saxagliptin reduce blood glucose as measured by HbA1c.

In AstraZeneca’s Respiratory area during 2016, Bevespi Aerosphere was approved in the United States and launched in early 2017.

The Respiratory team also made three regulatory submissions, including two in respect of benralizumab for treating severe, uncontrolled asthma. “We believe benralizumab, which would be our first Respiratory biologic, will become an important medicine for patients with severe asthma and potentially COPD, as well as an important growth driver for our company, broadening and deepening our offering in the Respiratory market,” Soriot says.

During September, AstraZeneca announced results from a subgroup analysis of the SIROCCO and CALIMA Phase III clinical trials. Management says the results confirm benralizumab’s compelling efficacy and identify key factors that predict which patients with severe, uncontrolled asthma would respond best to treatment with this potential new medicine.

Benralizumab is a monoclonal antibody that recruits natural killer cells, a component of the innate immune system, causing direct, rapid and near-complete depletion of eosinophils. Eosinophils are the biological effector cells that impact airway inflammation and airway hyper-responsiveness in approximately 50 percent of asthma patients, which leads to increased asthma symptoms, impaired lung function, and more frequent exacerbations.

In this post-hoc analysis, benralizumab demonstrated efficacy across the full range of baseline blood eosinophil counts, with an increased number of prior exacerbations and a higher baseline blood eosinophil count associated with a greater treatment effect. A combination of both higher baseline blood eosinophil count and a history of more frequent exacerbations predicted an even greater magnitude of response for patients treated with benralizumab.

The results were to be presented at the European Respiratory Society (ERS) International Congress 2017 in Milan, Italy and published simultaneously in The Lancet Respiratory Medicine. Executives say the overall safety profiles of the benralizumab and placebo arms were similar for both the SIROCCO and CALIMA trials, and the overall safety profile for benralizumab was in line with prior experiences.

Also in the Respiratory area, AstraZeneca in September announced positive top-line results from the Phase III AMPLIFY trial for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints, demonstrating a statistically significant improvement in lung function in patients with moderate-to-very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (either aclidinium bromide or formoterol). In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.

In another September announcement in the Respiratory field, AstraZeneca and Amgen Inc. (see profile on page 24) released results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma.

Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune, AstraZeneca’s global biologics research and development arm, in collaboration with Amgen.

The trial results were published in The New England Journal of Medicine on September 7 and were followed by an oral presentation on September 12 at the ERS International Congress 2017 in Milan.

In July, AstraZeneca and MedImmune announced that LEO Pharma received full marketing authorization in the European Union for Kyntheum (brodalumab ) for the treatment of adults with moderate-to-severe plaque psoriasis. LEO Pharma gained the approval in all 28 EU member countries plus Iceland, Liechtenstein, and Norway for Kyntheum. Kyntheum is the first fully-human monoclonal antibody that selectively targets the IL-17 receptor subunit A on skin cells

According to company executives, AstraZeneca set ambitious pipeline targets for the end of 2016. “For example, we aimed for nine to 10 new molecular entities (NMEs) in Phase III or registration by the end of 2016; there were 12 such projects,” Soriot says. “We also set ourselves the target of eight to 10 new medicines and major line extension regulatory approvals in 2015 to 2016 and achieved a total of eight. This is a significant improvement compared to our historical pipeline performance.”

Additionally, the company made substantial progress in reshaping its research and early development efforts to help to produce a steady stream of new products that will support its long-term growth. “We believed we had the potential for 12 to 16 Phase II starts in 2015 to 2016,” Soriot says. “In fact, we achieved 25. Looking ahead, we believe we have the potential for an unprecedented number of submissions in the next 24 months, with around half in our Oncology therapy area.”

To ensure that AstraZeneca can deliver this potential, during April 2016 company executives announced plans to sharpen further the prioritization of investments in main therapy areas, particularly Oncology. “We also want to increase partnering in relation to projects in our inflammation, infection and neuroscience disease areas,” Soriot says.

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