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AstraZeneca 2018: Gaining strength

Written by: | chris.truelove@medadnews.com | Dated: Tuesday, October 23rd, 2018

 

Even as AstraZeneca’s top-selling drugs continued to be affected by generic competition in 2017, executives say the company’s growth platforms will return the business to growth in 2018 and beyond.

 

 

 

 

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 2017 Sales 2016 Sales
Symbicort

$2,803

$2,989

Crestor $2,365 $3,401
Nexium

$1,952

$2,032

Pulmicort $1,176

$1,061

Brilinta/Brilique $1,079

$839  

Farxiga $1,074

$835

Tagrisso

$955

$423

Faslodex

$941

$830

Zoladex $735 $816
Toprol-XL/Seloken $695 $737
Synagis

$687

$677
Onglyza

$611

$720

Bydureon

$574

$578

Iressa

$528

$578 

All sales are in millions of dollars.

 

Financial Performance

  2017 2016
Revenue

$22,465

$23,002

Net income

$2,868

$3,406

Diluted EPS

$2.37

$2.76

R&D expense

$5,757

$5,890

 

  1H 2018 1H 2017
Revenue

$10,333

$10,456

Net income $635

$958

Diluted EPS

$0.54

$0.80

R&D expense

$2,641

$2,802

All figures are in millions of dollars, except EPS.

 

 

AstraZeneca leaders say 2017 represented a defining year for the company, and 2018 will be equally important.

“After experiencing the falling revenues of recent years, as some of our best-selling medicines lost exclusivity, our revenues improved over the course of 2017,” says Pascal Soriot, CEO of AstraZeneca. “Strong commercial execution helped us bring our science to more patients, making the most of our exciting pipeline. We made encouraging progress in all main therapy areas and delivered strong growth in China, our second largest market.”

CEO Pascal Soriot: “I am excited about AstraZeneca’s prospects as a science-led innovator as I believe we will deliver value for patients and shareholders in the long term.”

Back in 2013, AstraZeneca set a company strategy based on three pillars: Achieve scientific leadership; return to growth; and be a great place to work.

In 2017, AstraZeneca continued to make strides towards all those goals, Soriot says. Since 2013, the company has launched 13 new molecular entities, with four alone in 2017. “And, in 2017, we brought those medicines to more people with 19 major regional approvals – a new AstraZeneca record,” Soriot says. “It is an indicator of our scientific leadership in our three chosen therapy areas that we published 82 manuscripts in ‘high-impact’ scientific publications compared to 75 in 2016, and just seven in 2010. We are well on our way to meeting our longer-term goals of delivering one or more NMEs annually and sustainably delivering two NMEs annually by 2020.”

AstraZeneca’s performance between 2011 and 2017 was affected by lower sales of older products in established markets. Sales declined by more than $13 billion, after taking into account currency movements. The company expects to lose a further $1 billion of product sales in 2018, in particular through the loss of exclusivity for the cholesterol-lowering drug Crestor in Europe and Japan.

“But now, a new AstraZeneca is emerging from those headwinds, helped by our Growth Platforms, which gathered momentum during last year and grew by 5 percent (6 percent at CER),” Soriot says.

These growth platforms now represent 68 percent of AstraZeneca’s total revenue. Even as the company launched five medicines in 2017, AstraZeneca continued to unlock more uses for existing treatments, including for Lynparza and Tagrisso. In addition, expanded use of Brilinta/Brilique and Farxiga/Forxiga drove annual sales of these products beyond $1 billion for the first time.

“I am excited about AstraZeneca’s prospects as a science-led innovator as I believe we will deliver value for patients and shareholders in the long term,” Soriot says.

As AstraZeneca focuses on the pipeline, a legacy product franchise fell to the wayside. In the first half of 2018, the company announced an agreement to sell the commercial rights to Atacand (candesartan cilexetil) and Atacand Plus (fixed-dose combination of candesartan cilexetil and hydrochlorothiazide) in Europe to Cheplapharm Arzneimittel GmbH. Atacand is a prescription medicine for the treatment of heart failure and hypertension.

According to Mark Mallon, executive VP, Global Product & Portfolio Strategy at AstraZeneca, “This agreement forms part of our strategy of streamlining our portfolio of mature medicines to enable reinvestment in our main therapy areas and bringing new medicines to patients. Cheplapharm’s strong European presence will help expand the commercial potential of Atacand.”

The agreement was expected to be completed in the third quarter of 2018. AstraZeneca will continue to manufacture and supply Atacand and Atacand Plus under a supply agreement and will continue to commercialize the medicines in all markets where the company still holds the rights.

Cheplapharm will pay AstraZeneca $200 million on completion of the agreement, plus a time-bound payment of $10 million and sales-contingent milestones. In 2017, global product sales for Atacand and Atacand Plus were $300 million, including $86 million in Europe.

 

FINANCIAL RESULTS/PRODUCT SALES

Total overall revenue declined by 2.3 percent year-over-year in 2017, falling to about $22.47 billion. Product sales declined by 5 percent from nearly $21.32 billion in 2016 to $20.15 billion for last year. This result includes a decline in sales of Crestor and Seroquel XR. However, externalization revenue in 2017 increased by 37 percent (38 percent at CER) to $2.31 billion.

First-half 2018 revenue totaled $10.33 billion, 1.2 percent less than in the first half of the previous year. Executives say over the 2018 first half, the strong sales growth from new medicines and the continued strength of the Emerging Markets business were offset by the impact from the loss of Crestor exclusivity in Europe and Japan. “In line with expectations, an improved performance is anticipated in the second half, notably Product Sales, where guidance is reiterated for a low single-digit percentage increase over the full year at CER,” executives say.

Total comprehensive income for 2017 was reported at $3.7 billion, 25 percent less than in the previous year. The reduction in part reflects an increase in selling, general, and administrative expenses related to changes in the fair value of contingent consideration arising from the acquisition of the diabetes alliance from Bristol-Myers Squibb Co.

EPS in 2017 totaled $2.37, 14 percent less than in 2016. For the first half of 2018, reported operating profit was $1.46 billion, 20.8 percent less in the same period of 2017. Earnings per share were 54 cents compared with 80 cents in first-half 2017.
In 2017, AstraZeneca spent almost $5.76 billion for R&D, 2.3 percent less than in 2016. First-half 2018 R&D costs were $2.64 billion, 4.9 percent less than in the first half of 2017.

The top-selling products in 2017 at more than $500 million were Symbicort, Crestor, Nexium, Pulmicort, Brilinta, Farxiga, Tagrisso, Faslodex, Zoladex, Toprol-XL/Seloken, Synagis, Onglyza, Bydureon, and Iressa.

The respiratory drug Symbicort became AstraZeneca’s top-selling product in 2017, generating $2.8 billion, 6.2 percent less than in 2016. In the first half of 2018, sales were $1.31 billion, 6 percent less than in the same period of 2017.

Symbicort became AstraZeneca’s best-selling drug in 2017 at $2.8 billion, due to patent expirations affecting Crestor.

According to AstraZeneca executives, during the first half of 2018, Symbicort continued to lead the global market by volume within the inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) class. Sales of the drug in Emerging Markets grew by 13 percent (10 percent at CER) to $241 million, partly reflecting growth in China of 34 percent (24 percent at CER) to $119 million. In contrast, US sales declined by 21 percent to $439 million, reflecting continued pricing pressure and the timing of government buying, partly mitigated by market-share gains.

“The performance was in line with expectations, with challenging pricing pressure expected to continue,” executives say.

Because of patent expirations, Crestor slipped to No. 2 in the company’s product sales during 2017, generating almost $2.37 billion, 30.5 percent less than in 2016. Sales in the first half of 2018 showed a decline of 39 percent compared with the same period last year, at $727 million.

Creator sales in China grew by 33 percent (23 percent at CER) to $238 million in the 2018 first half, a result of underlying demand. Market growth in statin usage, AstraZeneca’s commercial strength in China, and the company’s successful strategy of broader coverage in China also continued to favorably impact sales. U.S. sales declined by 41 percent year-over-year to $90 million, reflecting the ongoing impact of multiple Crestor generic medicines. In Europe, sales declined 69 percent (72 percent at CER) to $111 million, reflecting the impact of the entry of generic Crestor medicines in various countries in 2017. AstraZeneca expected these impacts to begin to recede in second-half 2018.

In Japan, where Shionogi Co. Ltd. is a partner, the cholesterol medication’s sales declined by 71 percent (72 percent at CER) to $76 million, reflecting the impact of the entry of multiple Crestor competitors in the market in the second half of 2017. AstraZeneca expected this impact to recede in the second half of 2018. The decline also reflected actions by the Japanese government to focus further on incentives to increase the adoption of generic medicines.

No. 3 in yearly sales once again was the proton-pump inhibitor Nexium at $1.95 billion, a decline of 3.9 percent compared to 2016. For the first half of 2018, Nexium sales amounted to $890 million, a decline of 16 percent (19 percent at CER). Emerging Markets sales for the drug during January-June 2018 were stable (down by 3 percent at CER) at $343 million. Sales in the United States declined by 45 percent to $187 million in the half. Sales in Europe compared to first-half 2017 increased by 2 percent (down by 9 percent at CER) at $122 million. In Japan, where Daiichi Sankyo Co. Ltd. is a partner, sales declined by 2 percent (6 percent at CER) to $205 million, reflecting the biennial price cut implemented on April 1.

The fourth best-selling drug in 2017 was the respiratory drug Pulmicort, at about $1.18 billion, 10.8 percent more than 2016. First-half 2018 sales were $633 million, an increase of 12 percent (6 percent at CER). During the 2018 first half, Emerging Markets represented 76 percent of global sales and increased by 22 percent (15 percent at CER) to $482 million.

In China, Pulmicort’s first-half sales grew by 25 percent (16 percent at CER) to $401 million, despite a temporary supply constraint in the first quarter. The growth in the half reflected higher demand, strong underlying volume growth, and AstraZeneca’s delivery of more than 15,000 nebulization centers in China.

Sales in the United States declined by 24 percent versus the 2017 first half to $59 million and in Europe increased by 4 percent (down by 6 percent at CER) to $50 million, a consequence of the respiratory medicine’s legacy status there.

No. 5 in 2017 sales was the heart drug Brilinta, which represents one of AstraZeneca’s six focused growth platforms. Brilinta generated sales of $1.08 billion, 28.6 percent more than in 2016.

Brilinta is one of AstraZeneca’s growth engines, achieving sales of $1.08 billion in 2017.

First-half 2018 sales were reported at $609 million, generating an increase of 23 percent (18 percent at CER) versus the January-June 2017 performance. Emerging Markets sales of Brilinta grew by 22% (17% at CER) to $148 million, partly reflecting the benefits of inclusion on the NRDL in China in 2017.

U.S. sales of Brilinta, at $259 million in first-half 2018, represented growth of 20 percent. The performance, reflecting volume growth, was driven primarily by an increase in the number of patients initiated on Brilinta in the hospital and an increase in volume of 90-day prescriptions. Brilinta continued to deliver increasing levels of market share in the half. U.S. sales growth in Q2 2018 slowed to 13 percent, with sales of $144 million reflecting the impact of affordability programs. Sales in Europe, where the drug is marketed as Brilique, increased by 27 percent (14 percent at CER) to $172 million, reflecting indication leadership across various markets; sales were bolstered by the inclusion within HR PMI guidelines by the European Society of Cardiology in 2017. Brilique gained further reimbursement in key countries in its HR PMI indication with the 60mg dose.

The diabetes drug Farxiga/Forxiga in 2017 repeated as AstraZeneca’s sixth best-selling drug at $1.07 billion, 28.6 percent more than in 2016. In the first half of 2018, sales of the type 2 diabetes medicine were $639 million, an increase of 40 percent (36 percent at CER). Executives say Farxiga/Forxiga consolidated the product’s global leadership position within the sodium-glucose co-transporter 2 (SGLT2) inhibitor class.

Emerging Markets sales in the first two quarters of 2018 increased by 57 percent (59 percent at CER) to $157 million, reflecting ongoing launches and improved levels of patient access. In March 2017, Forxiga became the first SGLT2-inhibitor medicine to be approved in China, with encouraging levels of access and performance.

U.S. sales in first-half 2018 for Farxiga increased by 29 percent to $266 million. The product’s performance in the one-year-earlier period was adversely impacted by the company’s level of participation in affordability programs. Subsequent changes to AstraZeneca’s approach to these programs, however, helped to deliver a much-improved performance in first-half 2018.

Despite slowing growth in the United States, the SGLT2 class continued to be scientifically underpinned by growing evidence around cardiovascular benefits, including data from the CVD-REAL series of studies. First published in May 2017, the studies showed a statistically significant reduced rate of hospitalization for heart failure and death from any cause compared to other type 2 diabetes medicines.

Sales in Europe for Forxiga increased by 45 percent (28 percent at CER) versus first-half 2017 to $152 million. In Japan, sales grew by 40 percent (35 percent to CER) to $28 million.

Tagrisso sales more than doubled in 2017, reaching $955 million.

Leaping to No. 7 in 2017 sales was the lung cancer drug Tagrisso, which generated $955 million compared with $423 million in 2016.

In the first half of 2018, Tagrisso sales of $760 million represented growth of 89 percent (82 percent at CER), partly driven by increased testing rates and the April 2018 U.S. approval in the first-line setting. Continued growth was also delivered in the second-line indication in other countries. Sales in the United States grew by 89 percent to $341 million, with sequential growth in the second quarter of 32 percent to $194 million, reflecting a rapid uptake in the first-line setting that followed the April 2018 approval of Tagrisso as a first-line treatment of patients with metastatic EGFRm NSCLC. Tagrisso achieved market leadership in new patient starts for the first-line treatment of patients with EGFRm NSCLC in the United States. The product was approved in Europe for the same indication in June 2018.

Within Emerging Markets, Tagrisso sales grew by 298 percent (280 percent at CER) to $159 million, with notable growth in China, where the medicine was approved in March 2017 as a second-line treatment for patients with EGFR T790M-mutated NSCLC. Asia-Pacific has a relatively high prevalence of patients with an EGFR mutation at 30-40 percent compared to 10-15 percent in western markets.

In Europe, Tagrisso first-half 2018 sales of $139 million represented growth of 83 percent (63 percent at CER), driven by positive reimbursement decisions, further growth in testing rates and strong levels of demand. Sequentially, sales were stable as increased volumes were offset by adjustments to access agreements, some with retrospective effect, as the medicine reached more patients in each country. Following EU regulatory approval on June 8, 2018, for the initial treatment of patients with EGFRm NSCLC, Tagrisso launched in select EU countries, including in France and Germany. Reimbursement negotiations are under way elsewhere.

Sales of Tagrisso in Japan increased by 15 percent (11 percent at CER) over the January-June 2017 performance to $118 million, reflecting focused activities to maximize testing and utilization rates in the second-line indication. In August 2018, Japan’s Ministry of Health, Labour and Welfare approved Tagrisso as a first-line treatment for EGFRm NSCLC.

Coming in at No. 8 in 2017 was the oncology drug Faslodex, with sales of $941 million, 13.4 percent more than in 2016. In the first half of 2018, sales were $501 million, an increase of 8 percent (5 percent at CER) that reflected volume growth.

Emerging Markets sales for Faslodex grew by 31 percent (30 percent at CER) to $71 million compared to the 2017 first half. China sales grew by 100 percent (82 percent at CER) to $22 million. U.S. sales increased by 7 percent year-over-year to $259 million, mainly reflecting a continued strong uptake of the combination with the CDK4/6 class, a medicine approved for the treatment of hormone-receptor-positive breast cancer. Europe sales declined by 11 percent (21 percent at CER) to $118 million, reflecting the impact of generic entrants in certain countries. In June 2017, a label extension based upon the FALCON trial in the first-line setting was approved in Japan, where sales grew by 56 percent (50 percent at CER) to $50 million, despite the impact of the biennial price cut implemented on April 1, 2018.

AstraZeneca’s ninth best-selling drug in 2017 was the oncology drug Zoladex. The product’s sales declined 10 percent to $735 million. During the first half of 2018, sales reached $376 million, an increase of 4 percent (down by 1 percent at CER).

Zoladex’s Emerging Markets sales during first-half 2018 increased by 20 percent (17 percent at CER) to $202 million. Sales in Europe increased by 1 percent (down by 9 percent at CER) to $68 million. In the Established Rest Of World (ROW) region, sales declined by 10 percent (13 percent at CER) to $103 million, driven by the effects of increased competition. On March 31, 2017, AstraZeneca completed an agreement with TerSera for the sale of the commercial rights to Zoladex in the United States and Canada.

AstraZeneca’s 10th top seller in 2017 was another of its “legacy” products, the heart drug Toprol-XL/Seloken. The product generated $695 million, 5.7 percent less than in 2016. Sales of the product in first-half 2018 amounted to $373 million, 4 percent more than in first-half 2017.

Ranking No. 11 for AstraZeneca in 2017 was the RSV disease preventative Synagis. The drug achieved sales of $687 million, 1.5 percent more than in 2015. In the first half of 2018, sales were reported at $250 million, a decline of 17 percent compared with first-half 2017. U.S. sales declined by 25 percent to $125 million and continued to be impacted by the prevailing guidelines from the American Academy of Pediatrics Committee on Infectious Diseases. Product Sales to AbbVie Inc., responsible for the commercialization of Synagis in more than 80 countries outside the United States, declined by 6 percent to $125 million.

AstraZeneca’s 12th best seller in 2017 was the diabetes drug Onglyza, with sales declining from $720 million during 2016 to $611 million for 2017. Sales in the first half of 2018 were $255 million, 16 percent (19 percent at CER) less than in the first half of last year. Executives say the performance reflected adverse pressures on the dipeptidyl peptidase-4 (DPP-4) class and an acceleration of ongoing diabetes-market dynamics, where patients are moving to medicines and classes of medicines with documented CV benefits. “Given the significant future potential of Farxiga, the company continues to prioritize commercial support for Farxiga,” management says. In 2017, the diabetes drug Farxiga achieved annual sales of more than $1 billion for the first time.

In 2017, the diabetes drug Farxiga achieved annual sales of more than $1 billion for the first time.

Sales in Emerging Markets for Onglyza increased by 29 percent (24 percent at CER) to $81 million for the 2018 first half. After the addition onto the National Reimbursement Drug List (NRDL) in China in 2017, sales grew there by 136 percent (121 percent at CER) to $33 million, driving the Emerging Market sales growth. Sales in Europe declined by 10 percent (17 percent at CER) to $47 million, reflecting the broader trend of a shift away from the DPP-4 class.

Registering at No. 13 on the company’s 2017 drug sales list was the diabetes product Bydureon at $574 million. First-half 2018 sales totaled $294 million, a decline of 2 percent (3 percent at CER). Executives say an encouraging BCise device launch in the United States was reflected in an increase in second-quarter 2018 sales of 6 percent (5 percent at CER) to $155 million. But first-half sales in the United States declined by 4 percent to $234 million, reflecting pricing headwinds that offset an encouraging performance from the BCise launch. Bydureon sales in Europe increased 2 percent (down by 10 percent at CER) year-over-year to $43 million. At the end of August 2018, the European Commission approved the BCise device.

Coming in at No. 14 for the second consecutive year was the lung cancer drug Iressa, with sales increasing 2.9 percent from 2016 to $528 million. For the first half of this year, the company reported sales of $275 million, an increase of 5 percent (down by 1 percent at CER). Emerging Markets sales increased by 15 percent (8 percent at CER) to $148 million. China sales in first-half 2018 increased 27 percent (17 percent at CER) to $95 million. Iressa was included on the NRDL in 2017. Sales in the United States declined by 18 percent to $14 million and increased in Europe by 13 percent (2 percent at CER) to $61 million.

AstraZeneca executives say in the first half of 2018, new medicines generated more than $1 billion in additional sales at CER compared to first-half 2017. Product sales highlights included Oncology sales growth of 42 percent (37 percent at CER) to $2.66 billion. Besides Tagrisso, this takes into account Lynparza sales of $269 million, with growth of 132 percent (124 percent at CER) driven by expanded use in the treatment of ovarian cancer and a new approval for the use in the treatment of breast cancer. According to company management, the product had a very strong start in Japan following Lynparza’s launch in second-quarter 2018. Imfinzi sales of $184 million, with second-quarter 2018 sales of $122 million, reflect ongoing launches for the treatment of unresectable, Stage III NSCLC, where the number of new-patient starts continued to grow.

Emerging Markets were the largest region by Product Sales in the first six months of 2018, with growth of 14 percent (10 percent at CER) to $3.42 billion. This includes a China sales increase of 33 percent (24 percent at CER) to $1.89 billion. Underpinned by the launch of Tagrisso, executives say Oncology sales in China grew by 57 percent (46 percent at CER) to $403 million.

 

PUSHING THE PIPELINE

AstraZeneca is enthusiastically promoting the company’s pipeline. “If our launches are delivering benefits to patients now, our pipeline is intended to ensure we deliver those benefits sustainably in the years to come,” Soriot says. “During 2017, we made 18 NME or life-cycle management regulatory submissions in major markets and approved nine Phase III investment decisions. These will provide plenty of news in 2018 as we await regulatory decisions and data read outs from clinical trials. Looking further ahead, we approved 14 NME Phase II starts or progressions in 2017 which will shape our future in the years to come.”

In 2017, one of the company’s most significant R&D efforts was the global strategic oncology collaboration with MSD to jointly develop and commercialize Lynparza for multiple cancer types. AstraZeneca will also jointly develop with MSD and seek to commercialize the MEK inhibitor selumetinib, which is being developed for multiple indications, including thyroid cancer.

AstraZeneca is working to develop a diverse range of drug modalities such as modified RNA, antisense oligonucleotides, and bi-specific monoclonal antibodies (mAbs). Management plans to maintain scientific work on pioneering technologies including genome editing with CRISPR/Cas9, and machine learning and artificial intelligence.

Executives say AstraZeneca’s Precision Medicine and Genomics team is strengthening the company’s ability to match targeted medicines to patients who need them most.

The company had five significant launches in 2017 from each of its three main therapy areas. Imfinzi (durvalumab) received accelerated approval from the FDA in May 2017 for the treatment of advanced bladder cancer. The drug was AstraZeneca’s first immuno-oncology (IO) approval and represents the cornerstone of its IO program, in development across many tumor types, both as monotherapy and with other medicines.

In May 2017, AstraZeneca announced positive top-line results for the Phase III PACIFIC trial as Imfinzi demonstrated superior PFS in patients with locally advanced, unresectable NSCLC.

The product was approved in Japan during July 2018 as maintenance therapy after definitive chemoradiation therapy (CRT) in locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).

In October 2017, FDA granted accelerated approval of Calquence (acalabrutinib) as a treatment for relapsed or refractory mantle cell lymphoma (MCL). This represented another landmark for AstraZeneca as the company’s first approval in blood cancer and was cleared for marketing less than five months after the regulatory submission. With a development program including more than 35 clinical trials in multiple blood cancers, executives believe that the promise of Calquence is significant.

During November 2017, Fasenra (benralizumab) was approved in the United States for patients with severe asthma with an eosinophilic phenotype and is AstraZeneca’s first approved respiratory biologic medicine.

AstraZeneca announced in September 2018 results from the BORA Phase III extension trial evaluating the long-term safety and efficacy of Fasenra as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials. In the BORA trial, Fasenra given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. The improvements in efficacy measures observed with Fasenra in the studies were maintained over the second year of treatment. Patients who were treated with placebo in the SIROCCO or CALIMA trials and subsequently transitioned to Fasenra in the BORA trial experienced improvements in efficacy outcomes consistent with those observed for Fasenra-treated patients in the previous trials.

During September 2018, AstraZeneca announced the U.S. approval of Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukemia. This marks the first new treatment option for patients in more than 20 years. 75 percent of patients receiving Lumoxiti achieved an overall response, and 30 percent had a durable complete response.

According to Robert J. Kreitman, M.D., senior investigator, head of Clinical Immunotherapy Section, Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, and principal investigator of the Phase III trial, the approval is significant because while many patients with hairy cell leukemia experience a remission with current treatments, 30 percent to 40 percent will relapse five to 10 years after their first treatment.

Lumoxiti was approved under FDA priority review. The approval is based on data from the Phase III single-arm, open-label ‘1053’ trial of Lumoxiti monotherapy in 80 patients who have received at least two prior therapies, including a purine nucleoside analog. The primary endpoint of the trial was durable complete response.

Additionally during September, AstraZeneca and its partner Amgen Inc. announced that the FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

The Breakthrough Therapy Designation is based on the tezepelumab Phase IIb PATHWAY data showing a significant reduction in the annual asthma exacerbation rate versus placebo in a broad population of severe asthma patients irrespective of patient phenotype including Type 2 (T2) biomarker status. Currently available biologic therapies only target T2-driven inflammation. Tezepelumab is a potential first-in-class medicine that blocks thymic stromal lymphopoietin, an upstream modulator of multiple inflammatory pathways.

In August 2018, the European Medicines Agency granted orphan designation to selumetinib for the treatment of neurofibromatosis type 1 (NF1).

In first-half 2018, results from a new real-world analysis of more than 45,000 heart-attack survivors was published in Heart, suggesting that treatment with Brilinta plus low-dose aspirin, compared to clopidogrel plus low-dose aspirin, was associated with an 18 percent reduction of risk over one year for the composite endpoint of death, heart attack or stroke, in patients with moderate kidney disease. The results from PRACTICAL, an analysis of data from the ongoing SWEDEHEART registry, provided real-world evidence that patients who survived a heart attack and have moderate kidney disease had a lower risk of experiencing future CV events when treated with Brilinta rather than clopidogrel.

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