AstraZeneca 2019: Banking on oncology
AstraZeneca is rebuilding the company’s strength by making oncology one of the primary focuses in R&D and launching new drugs and indications in this therapy area.
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According to AstraZeneca’s leaders, the plan to “Return to Growth” is working. “As we enter the next phase in our journey, the fundamentals of our strategy and plans remain unchanged, with product sales growth driving improved profitability and the generation of increasing levels of cash,” says AstraZeneca CEO Pascal Soriot. As the world continues to change, “so we too are shifting the way in which we deliver our strategy,” Soriot says. “Our emphasis is on growth through innovation – being more patient-centric, doing more with digital technology and data, and advancing more innovative science.”
AstraZeneca’s strategy, set into place in March 2013 – shortly after Soriot joined AstraZeneca – remains “Achieve Scientific Leadership,” “Return to Growth,” and ensure the company is a “Great Place to Work.”
“Five years on, thanks to the great work of every single one of my colleagues, we have made remarkable progress: our science-led strategy and our open and entrepreneurial culture are underpinning a resurgence in innovation that is fueling sustainable product sales growth and delivering medicines that patients and society value and can access,” Soriot says.
The first phase entailed rebuilding the company’s pipeline. “Having regained our scientific edge, the second stage was crucial as we drove our Growth Platforms forward, launched new medicines, and made them available to patients,” Soriot says.
In 2018, after the previous six years in which revenue had fallen by more than one third, the company “turned the corner” and returned to product sales growth, driven by a new generation of medicines, according to Soriot.
“As we look ahead through 2019 and beyond, continued investment in our product launches and pipeline should keep us in track to deliver sustainable and profitable growth in line with our targets,” he says.
To achieve this, AstraZeneca is reshaping the way the company undertakes research and development to bring new focus and impetus, accelerate the launches of new medicines, and consolidate its pipeline.
“We are also reorganizing our commercial operations to reflect our therapy area focus, maximize collaboration with our R&D organization, and strengthen strategic planning and field force integration to support delivery of our medicines to patients,” Soriot says.
In support of its Return to Growth priority, AstraZeneca continues to focus on five Growth Platforms: Oncology, New CVRM, Respiratory, Japan, and Emerging Markets. Management says in 2013, these areas had represented less than half of sales but by 2018, they represented 84 percent of total revenue.
After four years of decline, executives say the United States returned to sales growth in 2018 for AstraZeneca while product sales in Emerging Markets, which represented 21 percent of sales in 2013, amounted to 33 percent. Executives say Emerging Markets now represents the company’s largest region by product sales.
Revenue was $22.09 billion in 2018, 1.7 percent less than in 2017. While total product sales in 2018 increased by 4 percent to $21.05 billion, driven by strong growth in the last two quarters of the year, externalization revenue slipped 55 percent to $1.04 billion, partly driven by the impact of $1.25 billion of income received during 2017 as part of AstraZeneca’s collaboration with MSD for Lynparza.
2018 net income was reported at $2.16 billion compared to $3 billion during the previous year. Earnings per share in 2018 were $1.70, down 28 percent at actual rate of exchange compared to 2017.
In first-half 2019, total revenue reached $11.31 billion, representing a 12 percent increase. Net income was $670 million, 6 percent more than in the same period of 2018. Diluted EPS amounted to 56 cents compared with 54 cents in first-half 2018.
In 2018, AstraZeneca spent $5.93 billion for R&D, 3 percent more than in 2018. First-half 2019 R&D costs were $2.62 billion, slightly less than in the first half of 2018.
Sales in the Oncology area were $6.03 billion in 2018, an increase of 50 percent from 2017. CVRM sales were $6.71 billion, down 8 percent versus the previous year. Sales in the Respiratory category were $4.91 billion, 4 percent more than in 2017. Sales of drugs in Other Disease Areas totaled $3.4 billion, 18 percent less than in the previous year.
In 2018, the company divided its Oncology business into five franchises that reflect both AstraZeneca’s commercial priorities and key scientific platforms. These franchises comprise Tagrisso and tumor drivers and resistance mechanisms; Imfinzi and immuno-oncology; Lynparza and DNA damage response (DDR); Calquence and hematology; and the Mature portfolio.
“These franchises enable us to best deliver against four strategic priorities we have embraced in order to achieve our ambition of eliminating cancer as a cause of death,” management says.
The company’s top-selling products in 2018 with sales of more than $500 million were Symbicort, Tagrisso, Nexium, Crestor, Farxiga, Brilinta, Pulmicort, Faslodex, Zoladex, Toprol-XL/Seloken, Synagis, Lynparza, Imfinzi, Bydureon, Onglyza, and Iressa.
The respiratory drug Symbicort was again AstraZeneca’s top-selling product in 2018, generating $2.56 billion, 8.6 percent less than in 2017. In the first half of 2019, sales of Symbicort declined 10 percent to $1.17 billion, which executives say reflects continued pricing pressure and the impact of managed-market rebates in the United States. This was partially offset by positive volumes from U.S. government-buying patterns
The lung cancer drug Tagrisso surged into second place in 2018, generating $1.86 billion compared with $955 million in 2017. In the first half of 2019, sales were $1.41 billion, representing growth of 86 percent in the half that was driven by 2018 regulatory approvals in the 1st-line EGFR7-mutated (EGFRm) NSCLC8 setting. There was a sequential quarterly increase of 16 percent in U.S. sales of Tagrisso from the first to the second quarter, partly reflecting continued underlying demand growth. Japan sales increased by 147 percent to $291 million.
No. 3 in sales for AstraZeneca was again the proton-pump inhibitor Nexium, at $1.7 billion, a decline of 13 percent from 2017. Management says Nexium is continuing to perform strongly in China, while sales for the rest of the world are in line with expectations given pressures from generic competition. For first-half 2019, sales were reported at $756 million, a year-over-year decline of 15 percent. First-half 2019 Emerging Markets sales of Nexium grew 8 percent to $369 million. In Europe, sales decreased 74 percent to $32 million, reflecting divestment activity. U.S. sales fell 36 percent to $119 million. In Japan, where AstraZeneca collaborates with Daiichi Sankyo Co. Ltd., sales improved by 1 percent to $207 million.
The fourth best-selling drug in 2018 was the cholesterol drug Crestor. Sales declined by 39 percent as the impact of generic competition continued to take effect. In the first half of 2019, sales were $645 million, 11 percent less than in the same period last year.
The diabetes drug Farxiga was the fifth best-selling drug in 2018, at $1.39 billion, 29.5 percent more than in 2017. The growth included a sales increase of 45 percent in Emerging Markets to $336 million. In the first half of 2019, sales of the drug were $726 million, an increase of 14 percent. Emerging Markets sales of Farxiga increased by 31 percent to $206 million, fueled by growth in China. U.S. sales increased by 2 percent to $270 million, impacted by changes in formulary access for competitor medicines. Sales in Europe rose 17 percent to $178 million. In Japan, sales to the collaborator, Ono Pharmaceutical Co. Ltd, which records in-market sales in Japan, increased by 32 percent to $37 million.
No. 6 in 2018 sales was the heart drug Brilinta, which is in the company’s CVRM area. Brilinta generated sales of $1.32 billion, 22 percent more than in 2017. The drug is approved in more than 100 countries for acute coronary syndromes and more than 60 countries for high-risk patients with history of heart attack. Executives say Brilinta delivered consistent quarter-over-quarter growth in 2018 in all regions.
First-half 2019 sales for Brilinta were reported at $$737 million, an increase of 21 percent. Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction. Emerging Markets sales of Brilinta increased by 47 percent to $217 million. U.S. sales of Brilinta, at $321 million, represented an increase of 24 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. Sales of the product in Europe, where it is marketed as Brilique, declined by 1 percent in the half to $171 million.
At No. 7 was the respiratory drug Pulmicort, at $1.29 billion, 9 percent more than 2018. The drug continued to deliver strong revenue growth, led by Emerging Markets in which China stood out. First-half 2019 sales were $716 million, an increase of 13 percent. Emerging Markets, where sales increased by 20 percent to $576 million, represented 80 percent of global sales of Pulmicort. Executives say China, making up the overwhelming majority of Pulmicort sales in Emerging Markets, delivered a particularly strong double-digit performance, strengthened by higher demand and underpinned by the impact of AstraZeneca’s support to build capacity in more than 17,000 nebulization centers.
Remaining at No. 8 in 2018 was the oncology drug Faslodex, with sales of $1.03 billion, 9.5 percent more than in 2017. In the first half of 2019, sales were $521 million, an increase of 4 percent. AstraZeneca executives anticipated increased challenges for the drug in the second half of the year, from additional generic Faslodex competition in the United States.
The company’s ninth best-selling drug in 2018 was the oncology drug Zoladex. Executives say the drug returned to value growth in 2018 following a six-year period of slowly declining sales across Europe and Japan. The growth was based on increased access to medical castration and ovarian suppression, as well as earlier detection and diagnosis in prostate and breast cancers, predominantly in China and the Emerging Markets. Sales grew to $752 million, 2.3 percent more than in the previous year.
During the first half of 2019 sales were $391 million, an increase of 4 percent. Emerging Markets sales of Zoladex increased by 16 percent to $235 million while sales in Europe declined by 4 percent to $65 million. In the Established RoW region, sales decreased by 16 percent to $87 million, driven by the effects of increased competition.
AstraZeneca’s 10th best seller in 2018 was once more another of its “legacy” products, the heart drug Toprol-XL/Seloken. The product generated $712 million, 2.4 percent more than in 2017. Sales of the product in first-half 2019 were $393 million, 4 percent more than in first-half 2018.
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 is appealing the ruling.
No. 11 was once again the RSV disease preventative Synagis. The drug had sales of $665 million, 3.2 percent less than in 2017. In first-half 2019, sales dropped 40 percent to $149 million. In November 2018, AstraZeneca sold the U.S. rights for Synagis to Swedish Orphan Biovitrum for $1.5 billion.
AstraZeneca’s 12th best seller in 2018 was the oncology drug Lynparza, sales of which jumped from $297 million to $647 million, driven by expanded use in the treatment of ovarian cancer and first approval in the treatment of breast cancer. Sales in the first half of 2019 were $520 million, 93 percent more than in the first half of last year. Executives say sales were driven by expanded use in the treatment of ovarian and breast cancer in the United States and Europe. The performance included growth in Emerging Markets of 228 percent to $59 million and growth in Japan of 480 percent to $58 million.
Surging to No. 13 in 2018 sales was the cancer drug Imfinzi, recording $633 million compared with $19 million the previous year. First-half 2019 sales were also $633 million, 244 percent more than in first-half 2018. While the majority of sales were in the United States, Europe sales amounted to $60 million compared with $3 million in first-half 2018, and sales in Japan came in at $86 million.
No. 14 was the diabetes drug Bydureon, sales of which were $584 million, 1.7 percent more than in 2017. First-half 2019 sales were $283 million, a decline of 4 percent. Executives attributed the decrease to production constraints that are now resolved.
AstraZeneca’s No. 15 product in 2018 sales was the diabetes drug Onglyza, at $543 million, 11 percent less than in 2017. Sales in the first half of 2019 were $269 million, an increase of 5 percent. According to management, the performance was partly driven by favorable prior-year gross-to-net adjustments in the United States, where sales increased by 22 percent to $120 million. Sales in Emerging Markets increased by 7 percent to $87 million, driven by the performance in China. Europe sales declined by 23 percent to $36 million, highlighting the broader trend of a shift away from the dipeptidyl peptidase-4 inhibitor class. Because of the significant future potential of Farxiga, AstraZeneca continues to prioritize commercial support for that product over Onglyza.
At No. 16 was the lung cancer drug Iressa, sales of which decreased 1.9 percent to $518 million. AstraZeneca executives attributed the decline to generic entries in select markets and the initial uptake of Tagrisso in first-line EGFRm advanced non-small cell lung cancer. For the first half of 2019, the company reported sales of $252 million, a decrease of 8 percent. Management says the product faces a pricing impact from centralized procurement in China.
Pushing the pipeline
AstraZeneca has been working on rebuilding the company’s pipeline, executives say. By 2015, the company had 15 new molecular entities in Phase III/pivotal Phase II trials or under regulatory review compared with a target, set in 2013, of 10 by the end of 2016. In 2018, the company had eight new molecular entities in Phase III/pivotal Phase II trials or under regulatory review. Also in 2018, the company made 28 regulatory submissions in major markets and received 23 approvals for our medicines. “Both are record numbers for AstraZeneca,” management says. “Of course, we know that in pushing the boundaries of science we will sometimes experience setbacks.”
For example, in 2018, there were disappointing Phase III trial results for six projects, including the MYSTIC trial of Imfinzi and tremelimumab in stage 4 non-small cell lung cancer.
“However, we remain confident in Imfinzi as the cornerstone of our immuno-oncology program and continue to evaluate its potential in ongoing NSCLC trials, including Imfinzi and Imfinzi plus tremelimumab in combination with chemotherapy,” executives say. “Overall, we are on target for sustainably delivering two NMEs annually by 2020.”
Management also claims AstraZeneca is well on its way to exceeding the company’s target of launching 10 major new medicines by 2020.
In 2018 alone, the company delivered three new medicines – Lumoxiti, Lokelma, and roxadustat. According to executives, roxadustat, for the treatment of chronic kidney disease anemia, is particularly noteworthy as it is the first time that a first-in-class medicine has been approved first in China.
AstraZeneca continues to focus its oncology research on four scientific platforms: tumor drivers and resistance, by developing therapies that target specific molecular mutations to attack cancer cells; immuno-oncology, which uses the body’s immune system to help fight cancer; DNA damage response, which targets the DNA repair process to block tumor cells’ ability to reproduce; and antibody-drug conjugates, which arm antibodies with cancer-killing agents for specific tumor targeting.
AstraZeneca received several pieces of good news throughout 2019 for its Oncology drugs. In September, Tagrisso was approved in China as a first-line treatment for EGFR-mutated non-small cell lung cancer.
The approval followed the Priority Review Pathway and is based on results from the Phase III FLAURA trial, which were published in The New England Journal of Medicine.
“The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new 1st-line treatment option for non-small cell lung cancer patients in China, where approximately 30-40 percent are diagnosed with an EGFR mutation – more than any other country in the world,” says Dave Fredrickson, executive VP, Oncology.
In the FLAURA trial, 1st-line use of Tagrisso provided a statistically significant and clinically meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death by a median of 18.9 months versus 10.2 months for those taking standard EGFR tyrosine kinase inhibitor (TKI) medicines. This benefit was consistent across all patient subgroups including those with central nervous system metastases.
In August, AstraZeneca announced that the Phase III PAOLA-1 trial for Lynparza met its primary endpoint as first-line maintenance treatment with bevacizumab for advanced ovarian cancer. The trial, in the first-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.
The study met its primary endpoint in the intent-to-treat population with a statistically significant and clinically meaningful improvement in PFS, increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone. PAOLA-1 is the second positive Phase III trial with Lynparza in first-line advanced ovarian cancer.
“The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer,” says José Baselga, executive VP, Oncology R&D. “Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a first-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible.”
Lynparza is being developed in a partnership with MSD. According to Roy Baynes, senior VP and head of Global Clinical Development, chief medical officer, MSD Research Laboratories, “The Phase III PAOLA-1 trial demonstrates MSD’s and AstraZeneca’s continued commitment to improving clinical outcomes for women with advanced ovarian cancer. … By studying Lynparza in this broader patient population, we have learned more about how it may help even more patients with advanced ovarian cancer in the future.”
Also during August, Calquence was granted U.S. Breakthrough Therapy Designation for chronic lymphocytic leukemia, as a monotherapy treatment. CLL is one of the most common types of leukemia in adults.
“This is an important regulatory milestone for our work in hematology and for patients living with chronic lymphocytic leukemia, a life-threatening disease,” Baselga says. “The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favorable safety profile.”
FDA granted the Breakthrough Therapy Designation based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.
This is the 10th Breakthrough Therapy Designation that AstraZeneca has received from the FDA since 2014. Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the United States, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.
In June, Lynparza was approved in Japan as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated (BRCAm) advanced ovarian cancer, as detected by an approved companion diagnostic test.
The approval by the Japanese Ministry of Health, Labor and Welfare was based on data from the pivotal Phase III SOLO-1 trial, which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
“This approval in Japan is a critical advance for women with ovarian cancer and a BRCA mutation,” says Dave Fredrickson, executive VP, Oncology Business Unit. “The goals of front-line therapy are long-term remission or a cure, yet currently 70 percent of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to transform patient outcomes.”
Lynparza also received a similar approval in the EU in June. The licensed indication is as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
“This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation,” Frederickson says. “The goals of front-line therapy have always been long-term remission and even cure, yet currently 70 percent of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.”
In June, AstraZeneca shared positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously untreated chronic lymphocytic leukemia, the most common type of leukemia in adults. This is the second Calquence pivotal trial in CLL to meet its primary endpoint early, following the positive results of the ASCEND trial, announced in May.
The study met the primary endpoint, as Calquence in combination with obinutuzumab demonstrated a statistically significant and clinically meaningful improvement in PFS when compared with the chemotherapy-based combo of chlorambucil and obinutuzumab.
The trial met a key secondary endpoint showing Calquence monotherapy achieved a statistically significant and clinically meaningful improvement in PFS versus the chemotherapy and obinutuzumab regimen.
Not everything in the Oncology area has gone smoothly. The company issued an update in August on the Phase III Neptune trial for Imfinzi plus tremelimumab in Stage IV non-small cell lung cancer. AstraZeneca had reviewed final overall survival (OS) results from the Phase III NEPTUNE trial, a randomized, open-label, multi-center, global trial of Imfinzi in combination with the anti-CTLA4 antibody tremelimumab vs. standard-of-care platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumor mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumor, and tumors with high levels of TMB may be more visible to the immune system.
In the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase (mut/Mb), the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving overall survival compared to standard-of-care chemotherapy.
“We are fully committed to a deep analysis of the vast clinical and biomarker data from this trial to gain further insights to improve Immuno-Oncology approaches for patients with metastatic non-small cell lung cancer,” Baselga says.
Despite the disappointment, AstraZeneca continues to push ahead in studies for the drug. Imfinzi is also being tested as monotherapy in the Phase III PEARL trial, and in combination with chemotherapy with or without tremelimumab in the Phase III POSEIDON trial as part of an extensive late-stage Immuno-Oncology program in Stage IV non-small cell lung cancer.
AstraZeneca had recent highlights in other development areas. In September, the company announced that Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets have been recommended for marketing authorization in the European Union for the treatment of adults with Type 2 diabetes. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from five Phase III trials which evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of metformin in patients with inadequately controlled type 2 diabetes. The primary endpoint in these trials was mean change from baseline in HbA1c (average blood glucose levels) at week 24 or 52.
Across the trials, the combination of Forxiga, Onglyza and metformin was superior in reducing HbA1c versus Forxiga combined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin. The combination of Forxiga, Onglyza, and metformin with or without sulfonylurea (SU) was non-inferior to the combined use of insulin and metformin with or without SU in reducing HbA1c.
Qtrilmet is approved in the United States under the name Qternmet XR as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
In September 2019, AstraZeneca received Fast Track designation for Farxiga to reduce the risk of cardiovascular death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction or preserved ejection fraction.
In August, AstraZeneca announced that FDA granted Orphan Drug Designation to Fasenra (benralizumab) for the treatment of eosinophilic esophagitis. The rare, chronic, inflammatory disease occurs when eosinophils, a type of white blood cell, accumulate in the esophagus causing injury and inflammation.
Fasenra is AstraZeneca’s first respiratory biologic medicine and is approved as an add-on maintenance treatment for severe, eosinophilic asthma in the United States, EU, Japan, and other countries. In November 2018, FDA granted Orphan Drug Designation for Fasenra for treating eosinophilic granulomatosis with polyangiitis, and also granted Orphan Drug Designation for the treatment of hypereosinophilic syndrome in February 2019.
AstraZeneca continues to engage in research collaborations. In March the company entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan, a proprietary antibody-drug conjugate and potential new targeted medicine for cancer treatment.
Trastuzumab deruxtecan is in development for the treatment of multiple HER2-expressing cancers, including breast and gastric cancer, and in patients with HER2-low expression. In 2017, trastuzumab deruxtecan was granted Breakthrough Therapy Designation by FDA for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after trastuzumab emtansine.
A first regulatory submission is scheduled for the second half of 2019 for patients in the advanced or refractory breast cancer setting. Additional development for the treatment of breast, non-small cell lung cancer, gastric and colorectal cancers is ongoing. The companies will jointly develop and commercialize trastuzumab deruxtecan worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.