REG - AstraZeneca PLC - Year-To-Date and Q3 2016 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 2
10/11/2016 07:10
- Part 2: For the preceding part double click ID:nRSJ8325Oa
supporting the progressive dividend policy and
maintaining a strong, investment-grade credit rating, the Board will keep under review potential investment in immediately
earnings-accretive, value-enhancing opportunities.
Sensitivity: Foreign-Exchange Rates
The Company provides the following currency sensitivity information:
Average Exchange Rates Versus USD Impact Of 5% Weakening In Exchange Rate Versus USD ($m)2
Currency Primary Relevance FY 2015 YTD 20161 Change % Total Revenue Core Operating Profit
EUR Product Sales 0.90 0.90 1 (178) (103)
JPY Product Sales 121.04 108.64 11 (102) (66)
CNY Product Sales 6.28 6.59 (5) (133) (62)
SEK Costs 8.43 8.40 - (8) 71
GBP Costs 0.65 0.72 (9) (34) 96
Other3 (201) (122)
1Based on average daily spot rates in the nine months to the end of September 2016.2Based on 2015 actual results at 2015 actual exchange rates.3Other important currencies include AUD, BRL, CAD, KRW and RUB.
Currency Hedging
AstraZeneca monitors the impact of adverse currency movements on a portfolio basis, recognising correlation effects. The
Company may hedge to protect against adverse impacts on cash flow over the short to medium term. As at 30 September 2016,
AstraZeneca had hedged 86% of forecast short-term currency exposure that arises between the booking and settlement dates on
Product Sales and non-local currency purchases.
Corporate and Business Development Update
______________________________________________________________________________________
The highlights of the Company's corporate and business development activities since the prior results announcement are
shown below.
a) Sale Of Small-Molecule Antibiotics Business
On 24 August 2016, the Company announced that it had entered into an agreement with Pfizer to sell the commercialisation
and development rights to its small-molecule antibiotics business and late-stage pipeline in most markets outside the US.
The agreement with Pfizer is expected to close in the fourth quarter of 2016, subject to customary closing conditions.
As AstraZeneca will de-recognise an intangible product asset and will not maintain a significant ongoing interest in the
late-stage, small-molecule antibiotics business, all payments will be reported as Other Operating Income in the Company's
financial statements. This includes the upfront payment of $550m and an unconditional payment of $175m in 2019 (both to be
recognised net of the carrying value of assets disposed and other costs to sell in 2016), the milestones of up to $250m,
sales-related payments of up to $600m and recurring double-digit royalties on sales of Zavicefta and ATM AVI.
b) Sale Of Rhinocort Aqua
On 7 October 2016, the Company announced that it had entered into an agreement with Cilag, an affiliate of Johnson &
Johnson, for the divestment of the rights to Rhinocort Aqua outside the US. Rhinocort Aqua is a nasal spray indicated for
allergic and non-allergic rhinitis (inflammation of the inside of the nose), and for the treatment of nasal polyps
(swelling of the nasal lining). The active ingredient is the anti-inflammatory medicine budesonide.
The agreement is subject to customary closing conditions and is expected to complete in the fourth quarter of 2016. As
AstraZeneca will not maintain a significant ongoing interest in Rhinocort Aqua, the $330m payment received from Cilag upon
completion of the transaction will be recognised as Other Operating Income in the Company's financial statements.
c) Externalisation Of Beta-Blocker Medicine Toprol-XL
On 31 October 2016, the Company completed an agreement with Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez
Pharmaceuticals Inc., for the rights to branded and authorised generic Toprol-XL (metoprolol succinate) in the US.
Toprol-XL is a beta-blocker medicine for the control of hypertension (high blood pressure), angina (chest pain) and heart
failure. It was first approved in the US in 1992.
AstraZeneca will retain a significant ongoing interest in Toprol-XL through retained ownership of the brand in Rest of
World (ROW) markets and product supply to Aralez. Therefore the upfront payment of $175m, milestones and sales-related
payments of up to $48m and mid-teen percentage royalties will be reported as Externalisation Revenue in the Company's
financial statements.
d) Licensing Agreement: Monoclonal Antibody MEDI2070
On 3 October 2016, the Company announced that MedImmune, its global biologics research and development arm, had entered
into a licensing agreement with Allergan for the global rights to MEDI2070. MEDI2070 is an IL-23 monoclonal antibody
currently in a Phase IIb clinical trial for moderate-to-severe Crohn's disease (a chronic inflammatory disease of the
intestines) and is ready for Phase II for ulcerative colitis (a chronic inflammatory condition of the colon and rectum).
MedImmune will continue the ongoing Phase II trials until a mutually-agreed transition date.
The transaction is expected to close in the fourth quarter of 2016, subject to customary closing conditions, including the
expiration or early termination of the waiting period under the Hart Scott Rodino Act. AstraZeneca is expected to retain
approximately $167m of the upfront payment and up to approximately $847m in future potential milestones, as well as the
tiered royalty payments of up to low double-digit percent, following payment to Amgen under the provisions of the original
agreement. As AstraZeneca will not retain a significant ongoing interest in MEDI2070, all income will be reported as Other
Operating Income in the Company's financial statements.
e) Benralizumab in Japan
On 28 October 2016, AstraZeneca exercised its exclusive option to commercialise benralizumab for the treatment of severe,
uncontrolled asthma and COPD in Japan. This follows the option agreement entered into with Kyowa in July 2015. Previously,
Kyowa held the exclusive development and commercialisation rights for benralizumab in Japan, as well as certain other
countries in Asia, while AstraZeneca has exclusive rights in all other countries, including the US and Europe. On
exercising the option, AstraZeneca is responsible for all sales and marketing activity for benralizumab in asthma and COPD
in Japan.
f) Externalisation of Bydureon and Byetta in China
On 10 October 2016, AstraZeneca entered into a strategic collaboration with 3SBio for the rights to commercialise Bydureon
and Byetta in the Chinese market. The agreement allows the Company to benefit from 3SBio's established expertise in
injectable medicines and also focus resources on AstraZeneca's oral diabetes franchise, including Onglyza, which is already
marketed in China, as well as Forxiga and Kombiglyze, which are anticipated to launch in China in 2017.
Under the terms of the collaboration agreement, 3SBio will make an upfront payment of $50m and will pay development
milestones of up to a further $50m for the exclusive rights to commercialise Bydureon and Byetta in the Chinese market
(excluding Hong Kong) for an initial period of 20 years. AstraZeneca will retain a significant ongoing interest in Bydureon
and Byetta through retained ownership of the brands in other markets and will manufacture and supply these medicines to
3SBio for an agreed purchase price. Therefore the upfront payment and development milestones will be reported as
Externalisation Revenue in the Company's financial statements.
Research and Development Update
______________________________________________________________________________________
A comprehensive table with AstraZeneca's pipeline of medicines in human trials can be found later in this document.
Since the results announcement on 28 July 2016 (the period):
Regulatory Approvals 1 - Brilinta - CV disease (JP)
Regulatory Submissions* /Acceptances 3 - Faslodex - breast cancer (1st line) (JP)*- Tagrisso - lung cancer (CN)*- ZS-9 - hyperkalaemia (US)
Positive Phase III Data Readouts 3 - Lynparza - ovarian cancer (2nd line) - Farxiga + Bydureon - type-2 diabetes - benralizumab - severe, uncontrolled asthma
Other Key Developments 2 - Priority Review Designation: Tagrisso (CN)- Fast Track Designation: AZD3293 - Alzheimer's disease (US)
New Molecular Entities (NMEs) in Pivotal Trials or under Regulatory Review**# 13 Oncology- durvalumab - multiple cancers- durva + treme - multiple cancers- acalabrutinib - blood cancers- moxetumomab pasudotox - leukaemia-
selumetinib - thyroid cancer Cardiovascular & Metabolic Diseases- ZS-9** - hyperkalaemia- roxadustat - anaemia Respiratory- benralizumab - severe,
uncontrolled asthma- tralokinumab - severe, uncontrolled asthma- PT010 - COPD Other- brodalumab - psoriasis**- anifrolumab - lupus- AZD3293 -
Alzheimer's disease
Projects in clinical pipeline# 138
# As at 10 November 2016
ONCOLOGY
AstraZeneca has a deep-rooted heritage in Oncology and offers a growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020
and a broad pipeline of small molecules and biologics in development, the Company is committed to advancing New Oncology as
one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers.
In addition to core capabilities, the Company is actively pursuing innovative collaborations and investments that
accelerate the delivery of AstraZeneca's strategy, as illustrated by the Company's recent investment in Acerta Pharma in
haematology.
At the recent European Society for Medical Oncology meeting, AstraZeneca highlighted its progress in Oncology with 46
scientific presentations, including new 1st-line data that demonstrated the superiority of Faslodex over the current
standard of care in postmenopausal women with HR-positive, locally-advanced or metastatic breast cancer. The Company also
presented updated safety and efficacy data from two cohorts from Study 1108; durvalumab monotherapy in NSCLC and HNSCC, in
addition to a comparative analysis of PD-L1 diagnostic assays in c.500 HNSCC-tumour samples.
a) Lynparza (ovarian and other cancers)
Lynparza continues to be the cornerstone of the AstraZeneca DNA Damage Response (DDR) line of medicines. An extensive
lifecycle programme is underway, including in earlier lines of treatment in metastatic ovarian, breast and prostate
cancers. For the potential treatment in metastatic BRCA-mutated breast cancer, the OLYMPIAD trial has seen fewer events
than originally expected and, as a consequence, the data readout is now anticipated to be in the first half of 2017.
During the period, the Company reported positive results from the Phase III SOLO-2 trial designed to determine the efficacy
of Lynparza tablets (300mg, twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed,
BRCA-mutated ovarian cancer. Results from the trial demonstrated a clinically-meaningful and statistically-significant
improvement of progression-free survival (PFS) among patients treated with Lynparza, compared to placebo and provided
additional evidence to support the use of Lynparza in this patient population.
b) Tagrisso (lung cancer)
During the period, Tagrisso was accepted for submission and granted Priority Review status by the China Food and Drug
Administration agency as a potential treatment for patients with locally-advanced, or metastatic EGFR T790M
mutation-positive NSCLC, who have been previously treated with EGFR TKI therapy. The designation has the potential to
expedite more rapid access to Tagrisso for patients in China. The Chinese application was supported by three key trials - a
China-led Asian regional trial (AURA17), a pharmaco-kinetic trial in the local population (AURA18) and the global AURA3
trial, which included Chinese patients.
c) Cediranib (ovarian cancer)
On 21 September 2016, AstraZeneca announced the decision to voluntarily withdraw the marketing authorisation application
(MAA) submitted to the EMA's Committee for Medicinal Products for Human Use for cediranib in combination with
platinum-based chemotherapy, followed by maintenance monotherapy for the treatment of adult patients with
platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal). The decision to withdraw the
MAA was based on questions raised by the EMA at the late stage of the review process. The MAA for cediranib was supported
by data from ICON6, a Phase III trial led by investigators from University College, London and the Medical Research
Council. The Company has not made additional regulatory submissions for cediranib in this indication in any other markets.
Cediranib remains an important part of AstraZeneca's ovarian cancer pipeline, and a number of Phase III trials are ongoing
to test cediranib as a potential combination partner with Lynparza and other pipeline medicines; these trials are not
affected by the aforementioned withdrawal.
d) Selumetinib (multiple cancers)
On 9 August 2016, the Company announced the high-level results from the Phase III SELECT-1 trial for selumetinib in
patients with 2nd-line KRAS mutant (KRASm) NSCLC. The results showed that the trial did not meet its primary endpoint of
PFS, and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib
and docetaxel were consistent with those seen previously. This outcome did not impact the on-going selumetinib programme in
differentiated thyroid cancer, in paediatric neurofibromatosis Type 1 (in collaboration with the US National Cancer
Institute), and in combination with other potential medicines in a range of tumour types.
e) Savolitinib (multiple cancers)
Based on data from multiple Phase I/II trials, savolitinib has shown early clinical benefit as a highly selective c-Met
inhibitor in a number of cancers. As a result, Chi-Med (part of CK Hutchison Holdings Limited) and AstraZeneca have
expanded the joint development plan for savolitinib to cover multiple c-Met-driven, solid tumour indications including
NSCLC, kidney, gastric and colorectal cancers.
f) Durvalumab (multiple cancers)
The Company continues to advance multiple monotherapy trials of durvalumab and combination trials of durvalumab with
tremelimumab and other potential medicines in Immuno-Oncology (IO). An update on key AstraZeneca-sponsored ongoing trials
with durvalumab is provided over the page:
LUNG CANCER Name Phase Line of treatment Population Design Timelines Status Early disease Monotherapy ADJUVANT1 III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo FPD2 Q1 2015 Data expected 2020 Ongoing PACIFIC III N/A Stage III unresectable NSCLC durvalumab vs placebo FPD Q2 2014 LPCD3 Q2 2016 Data expected H2 2017 Recruitment completed Advanced/metastatic disease Combination therapy MYSTIC III 1st line NSCLC durvalumab vs durva + treme vs SoC4 FPD Q3 2015
LPCD Q3 2016 Data expected H1 2017 Recruitment completed NEPTUNE III 1st line NSCLC durva + treme vs SoC FPD Q4 2015 Data expected 2018 Ongoing - III 1st line NSCLC durvalumab + chemotherapy +/- tremelimumab - Ongoing in safety lead-in Phase I/II trial ARCTIC III 3rd line PD-L1 neg. NSCLC durvalumab vs tremelimumab vs durva + treme vs SoC FPD Q2 2015 LPCD Q3 2016 Data expected H1 2017 Recruitment completed 1 Conducted by the National Cancer Institute of Canada 2 FPD = First Patient Dosed 3LPCD = Last
Patient Commenced Dosing4 SoC = Standard of Care 5 SCLC = Small Cell Lung Cancer METASTATIC OR RECURRENT HEAD AND NECK CANCER Name Phase Line of treatment Population Design Timelines Status Monotherapy HAWK II 2nd line PD-L1 pos. HNSCC Durvalumab (single arm) FPD Q1 2015
LPCD Q2 2016
Data expected Q4 2016 (internal availability) Recruitment completed Combination therapy CONDOR II 2nd line PD-L1 neg. HNSCC durvalumab vs tremelimumab vs durva + treme FPD Q2 2015 LPCD Q2 2016 Data expected H1 2017 Recruitment completed KESTREL III 1st line HNSCC durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected H2 2017 Ongoing EAGLE III 2nd line HNSCC durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Ongoing
Early disease Monotherapy
ADJUVANT1 III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo FPD2 Q1 2015 Data expected 2020 Ongoing
PACIFIC III N/A Stage III unresectable NSCLC durvalumab vs placebo FPD Q2 2014 LPCD3 Q2 2016 Data expected H2 2017 Recruitment completed
Advanced/metastatic disease Combination therapy
MYSTIC III 1st line NSCLC durvalumab vs durva + treme vs SoC4 FPD Q3 2015 Recruitment completed
LPCD Q3 2016 Data expected H1 2017
NEPTUNE III 1st line NSCLC durva + treme vs SoC FPD Q4 2015 Data expected 2018 Ongoing
- III 1st line NSCLC durvalumab + chemotherapy +/- tremelimumab - Ongoing in safety lead-in Phase I/II trial
ARCTIC III 3rd line PD-L1 neg. NSCLC durvalumab vs tremelimumab vs durva + treme vs SoC FPD Q2 2015 LPCD Q3 2016 Data expected H1 2017 Recruitment completed
ARCTIC
III
3rd line
PD-L1 neg. NSCLC
durvalumab vs tremelimumab vs durva + treme vs SoC
FPD Q2 2015 LPCD Q3 2016 Data expected H1 2017
Recruitment completed
1 Conducted by the National Cancer Institute of Canada 2 FPD = First Patient Dosed 3LPCD = Last Patient Commenced
Dosing4 SoC = Standard of Care 5 SCLC = Small Cell Lung Cancer METASTATIC OR RECURRENT HEAD AND NECK CANCER
Name Phase Line of treatment Population Design Timelines Status
Monotherapy
HAWK II 2nd line PD-L1 pos. HNSCC Durvalumab (single arm) FPD Q1 2015 Recruitment completed
LPCD Q2 2016
Data expected Q4 2016 (internal availability)
Combination therapy
CONDOR II 2nd line PD-L1 neg. HNSCC durvalumab vs tremelimumab vs durva + treme FPD Q2 2015 LPCD Q2 2016 Data expected H1 2017 Recruitment completed
KESTREL III 1st line HNSCC durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected H2 2017 Ongoing
EAGLE III 2nd line HNSCC durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Ongoing
With recent changes in the HNSCC competitive landscape, including the approval in the US for PD-1 monotherapy for recurrent
or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy, the Company is unlikely to make
a regulatory submission for this single-arm Phase II trial. This trial in PD-L1+ patients was originally designed as a
potential fast-to-market opportunity in 2nd-line HNSCC. The HAWK trial results are anticipated to be available internally
in due course, following trial conclusion and data analysis.
On 27 October 2016, AstraZeneca confirmed that the FDA had placed a partial clinical hold on the enrolment of new patients
with HNSCC in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential
medicines. All trials are continuing with existing patients. The partial clinical hold on new patient enrolment relates
only to HNSCC. Trials for durvalumab in different cancer types, as monotherapy, or in combination with tremelimumab or
other potential medicines, are progressing as planned with pivotal data in lung cancer anticipated in the first half of
2017.
METASTATIC UROTHELIAL BLADDER CANCER
Name Phase Line of treatment Population Design Timelines Status
Combination therapy
DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Ongoing
g) Acalabrutinib (blood cancers)
Based on maturity of clinical data in an intended fast-to-market indication of unmet need in B-cell blood cancers, the
Company rolled the potential data readout and regulatory submission for one blood cancer to the first half of 2017.
Acalabrutinib is a cornerstone of the AstraZeneca strategy in haematology and the Company continues to see important
progress in the clinical-development programme for the potential medicine. With more than 2,000 patients now having been
treated with acalabrutinib in clinical trials, the safety profile supports the potential for acalabrutinib to become a
best-in-class BTK inhibitor for patients intolerant to a currently-approved BTK inhibitor with B-cell cancers.
CARDIOVASCULAR & METABOLIC DISEASES
This therapy area includes a broad type-2 diabetes portfolio, differentiated devices and unique small and large-molecule
programmes to reduce morbidity, mortality and organ damage across CV disease, diabetes and chronic kidney disease (CKD)
indications.
a) Brilinta (CV disease)
During the period, the EUCLID Phase III trial in Peripheral Artery Disease (PAD) readout, with the data demonstrating that
the primary endpoint of superiority over clopidogrel was not met. Safety findings from the trial were in line with the
known safety profile of Brilinta. Based on the current expectations, it is unlikely that the Company will seek regulatory
submission of an indication in PAD.
During the period, the Japanese Ministry of Health, Labour and Welfare approved Brilinta 90mg for patients with acute
coronary syndrome (ACS) for whom the use of other antiplatelet medicines in combination with aspirin is difficult. Brilinta
60mg was also approved for patients who have suffered a heart attack at least one year prior and are at high risk of
developing a further atherothrombotic event.
b) Farxiga + Bydureon (type-2 diabetes)
With the increasing evidence suggesting the beneficial effect of SGLT2 inhibitors, such as Farxiga, on renal and CV
outcomes in patients with type-2 diabetes, the decision was made to design two large Phase IIIb outcome trials to further
investigate the potential role of Farxiga in the management of CKD and chronic heart failure (CHF), in patients with or
without type-2 diabetes. This marked the first time that a major outcome trial will be conducted to evaluate an SGLT2
inhibitor in CKD, for which there are currently few treatment options and a significant unmet medical need.
During the period, the DURATION-8 combination trial of Farxiga and Bydureon showed reduced blood sugar, weight and systolic
blood pressure. The Phase III trial demonstrated that the combination of these medicines provides benefits to patients
above and beyond what is seen with the individual medicines. The Company is currently assessing the potential for a
regulatory submission based on these data.
c) Type-2 diabetes medicines in CV outcomes trials
As the field of type-2 diabetes medicines consistently evolves, with multiple outcomes trials producing data, AstraZeneca
continues to assess both Farxiga and Bydureon for potential long-term CV benefits. Two significant type-2 diabetes outcomes
trials are underway and are ongoing:
Medicine Trial Mode of Action Number of Patients Primary Endpoint Timeline
Bydureon EXSCEL GLP-1 agonist ~15,000 Time to first occurrence of CV death, non-fatal MI or non-fatal stroke Latest 2018(final analysis)
Farxiga DECLARE SGLT2 inhibitor ~17,000* Time to first occurrence of CV death, non-fatal MI or non-fatal stroke Latest 2019(final analysis) 2017(anticipated interim analysis)
*Includes ~10,000 patients who have had no prior index event (primary prevention) and ~7,000 patients who have suffered an
index event (secondary prevention).
d) ZS-9 (hyperkalaemia)
In the beginning of the fourth quarter, the FDA accepted AstraZeneca's resubmission of the new drug application (NDA) for
ZS-9 (sodium zirconium cyclosilicate), the medicine in development for the treatment of hyperkalaemia (high potassium level
in blood serum) by ZS Pharma, a wholly owned subsidiary of AstraZeneca. The FDA indicated that this was a complete Class 2
response; the Agency is anticipated to act on the resubmission within 6 months of the date of receipt.
e) Roxadustat (anaemia)
Roxadustat is a potential first-in-class oral HIF-PH inhibitor in Phase III development for the treatment of anaemia in CKD
patients, including those on dialysis and not on dialysis. AstraZeneca, FibroGen, Inc. (Fibrogen) and Astellas Pharma Inc.
are jointly undertaking an extensive worldwide Phase III programme consisting of 15 trials enrolling more than 8,000
patients.
FibroGen, responsible for regulatory activities in China, recently announced that enrolment had completed in both Phase III
clinical trials, intended for regulatory submission. These trials include both CKD patients on and not on dialysis.
Further, FibroGen has confirmed that roxadustat is on track to initiate the rolling regulatory-submission process in 2016.
RESPIRATORY
AstraZeneca's Respiratory portfolio includes a range of differentiated potential medicines such as novel combinations,
biologics and devices for the treatment of asthma and COPD.
Benralizumab (severe, uncontrolled asthma)
AstraZeneca shared positive benralizumab Phase III data from the SIROCCO and CALIMA trials at the recent European
Respiratory Society meeting. These data were also published in The Lancet on 5 September 2016. These results demonstrated
that adding benralizumab to the standard of care significantly reduced exacerbations and improved lung function and asthma
symptoms in severe, uncontrolled asthma. The outcomes were demonstrated for the 8-week dosing regimen, with no additional
benefit observed with 4-week dosing.
During the period, the Phase III ZONDA trial also met its primary endpoint. ZONDA is an efficacy and safety trial of
benralizumab to reduce oral corticosteroid use in patients with uncontrolled asthma on high-dose, inhaled corticosteroid
plus long-acting Beta2 agonist and chronic oral corticosteroid therapy. Full results will be presented at a forthcoming
medical meeting. ZONDA is the fourth positive efficacy trial supporting benralizumab's unique efficacy and safety profile
in severe, uncontrolled asthma.
OTHER
a) Anifrolumab (lupus)
During the period, the first patient completed the anifrolumab systemic lupus erythematosus (SLE) Phase III trial and
rolled over to the long-term extension trial for another three years of treatment/follow-up. The Phase III programme
consists of two double-blind placebo controlled trials (TULIP SLE1 and TULIP SLE2) as well as the long-term extension; the
Company continues to anticipate regulatory submission in 2019.
Anifrolumab is a monoclonal antibody that blocks the type I interferon (IFN) receptor, thereby inhibiting the activity of
all type I IFNs, which play a central role in lupus pathophysiology. Anifrolumab is currently in Phase III development for
SLE and Phase II for Lupus Nephritis; a Phase I trial for expansion from current intravenous to subcutaneous administration
was recently completed.
b) AZD3293 (Alzheimer's Disease)
On 22 August 2016, AstraZeneca and Lilly announced the receipt of the FDA's Fast Track Designation for the development
programme in Alzheimer's disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase
III clinical trial. The FDA's Fast Track programme is designed to expedite the development and review of new therapies to
treat serious conditions and tackle key unmet medical needs. Lilly leads clinical development, in collaboration with
scientists from AstraZeneca who will be responsible for manufacturing.
AZD3293 has been shown in trials to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer's and
healthy volunteers. The progression of Alzheimer's disease is characterised by the accumulation of amyloid plaque in the
brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the
formation of amyloid plaque and eventually slow the progression of the disease. In addition to the AMARANTH Phase III trial
for AZD3293, AstraZeneca and Lilly have dosed patients in a second Phase III trial, DAYBREAK-ALZ, which studies the safety
and efficacy of AZD3293 in patients with mild Alzheimer's disease.
ASTRAZENECA DEVELOPMENT PIPELINE 30 SEPTEMBER 2016
AstraZeneca-sponsored or -directed studies
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional indications
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by
the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed
at this time.
Oncology
TagrissoAURA, AURA2, (AURA17 Asia regional) EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q2 2014 Launched(Breakthrough Therapy, Priority Review, Orphan drug) Launched (Accelerated assessment) Approved Accepted1
TagrissoAURA3 EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q3 2014 Q4 2016 Q4 2016 N/A2 N/A
acalabrutinib# BTK inhibitor B-cell malignancy Q1 2015 2017(Orphan drug)
acalabrutinib# BTK inhibitor 1st-line CLL Q3 2015 2020(Orphan drug) 2020(Orphan drug)
acalabrutinib# BTK inhibitor r/r CLL, high risk Q4 2015 2020(Orphan drug) 2020(Orphan drug)
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2018(Orphan drug) 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 2017(Orphan drug) 2018
immunotoxin
durvalumab#PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 2017 2017 2017
durvalumab# PD-L1 mAb 2nd-line HNSCC (PD-L1 positive) Q1 2015 2017(Fast Track) 2017
HAWK¶
durvalumab# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 2017 2017 2017
ARCTIC
durvalumab# + tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q3 2015 2017 2017 2017 2020
durvalumab# + tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q4 2015 2019 2019 2019
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line HNSCC (PD-L1 negative) Q2 2015 2017 2017
CONDOR¶
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line HNSCC Q4 2015 2018 2018 2018
KESTREL
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line HNSCC Q4 2015 2018 2018 2018
EAGLE
durvalumab# + tremelimumabALPS¶ PD-L1 mAb + CTLA-4 mAb metastatic pancreatic ductal carcinoma Q4 2015 2017 2017 2017
durvalumab# + tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder cancer Q4 2015 2018 2018 2018
Cardiovascular & Metabolic Diseases
Brilinta3 P2Y12 receptor antagonist arterial thrombosis Launched Launched Approved3 Launched
Farxiga4 SGLT2 inhibitor type-2 diabetes Launched Launched Launched Accepted
Epanova# omega-3 carboxylic acids severe hypertrigly-ceridemia Approved 2018
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia Accepted5 Accepted
roxadustat# OLYMPUS (US) ROCKIES (US) hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD/ESRD Q3 2014 2018 N/A N/A Q4 20166
Respiratory
Bevespi Aerosphere (PT003) LABA/LAMA COPD Q2 2013 Approved 2017 2018 2018
benralizumab#CALIMA SIROCCO ZONDABISEBORAGREGALE IL-5R mAb severe asthma Q4 2013 Q4 2016 Q4 2016 N/A N/A
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 2018 2018 N/A N/A
PT010 LABA/LAMA/ICS COPD Q3 2015 2018 2018 2018 2019
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe asthma Q3 2014 2018 2018 2018
Other
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
Zinforo#7 extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia/skin infections N/A Launched N/A Submitted
Zavicefta#7 (CAZ AVI#) cephalosporin/ beta lactamase inhibitor hospital-acquired pneumonia/ ventilator-associated pneumonia Q2 2013 N/A Approved N/A 2017
Zavicefta#7 cephalosporin/beta lactamase inhibitor serious infections, complicated intra-abdominal infection, complicated urinary tract infection Q1 2012 N/A Approved N/A 2017
AZD3293#AMARANTHDAYBREAK-ALZ beta-secretase inhibitor Alzheimer's disease Q2 2016 20208(Fast Track) 2020 2020
N/A
2017
AZD3293#AMARANTHDAYBREAK-ALZ
beta-secretase inhibitor
Alzheimer's disease
Q2 2016
20208(Fast Track)
2020
2020
¶ Registrational Phase IItrial
# Collaboration
1 CN submission accepted 1 September 2016
2 Tagrisso has full approval in Japan. A Japanese Patient Information update will include AURA3 data
3 Brilinta in the US; Brilique in rest of world. JP approval received 28 Sept 2016
4 Farxiga in the US; Forxiga in rest of world
5 US resubmission accepted on 13 October 2016
6 Rolling NDA submission to be initiated in Q4 2016
7 AstraZeneca announced on 24 August 2016 that it had entered into an agreement with Pfizer to sell the commercialisation
and development rights to its late-stage, small-molecule antibiotics business in most markets globally outside the US. The
transaction is expected to close during Q4 2016
8 Fast Track Designation, 22 August 2016
Phases I and II
NMEs and significant additional indications
Oncology
durvalumab# PD-L1 mAb bladder cancer II Q1 2016(Breakthrough Therapy)
durvalumab# PD-L1 mAb solid tumours II Q3 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
durvalumab# + AZD5069 PD-L1 mAb + CXCR2 HNSCC II Q3 2015
durvalumab# + AZD9150# PD-L1 mAb + STAT3 inhibitor
durvalumab# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours II Q3 2016
durvalumab# PD-L1 mAb solid tumours I Q3 2014
durvalumab# + monalizumab PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
durvalumab# + MEDI9447 PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
durvalumab#+ Iressa PD-L1 mAb+ EGFR tyrosine kinase inhibitor NSCLC I Q2 2014
durvalumab# + dabrafenib + trametinib PD-L1 mAb+ BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
Tagrisso + (durvalumab# or selumetinib# or savolitinib#)TATTON EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor) advanced EGFRm NSCLC II Q2 2016
Tagrisso EGFRm leptomeningeal disease II Q3 2016
selumetinib + durvalumab# MEK inhibitor + PD-L1 mAb solid tumours I Q4 2015
savolitinib/volitinib# MET tyrosine kinase inhibitor papillary renal cell carcinoma II Q2 2014
AZD1775#+ chemotherapy Wee1 inhibitor + chemotherapy ovarian cancer II Q4 2012
AZD1775# Wee1 inhibitor solid tumours I Q3 2015
AZD1775# + Lynparza Wee1 inhibitor + PARP inhibitor solid tumours I Q3 2015
AZD1775# + durvalumab# Wee1 inhibitor + PD-L1 mAb solid tumours I Q4 2015
AZD6738 + Lynparza ATR inhibitor gastric cancer II Q3 2016
vistusertib (AZD2014) mTOR serine/ threonine kinase inhibitor solid tumours II Q1 2013
AZD3759 BLOOM# EGFR tyrosine kinase inhibitor CNS metastases in advanced EGFRm NSCLC II Q4 2015
Tagrisso BLOOM EGFR tyrosine kinase inhibitor
AZD5363# AKT kinase inhibitor breast cancer II Q1 2014
AZD4547 FGFR tyrosine kinase inhibitor solid tumours II Q4 2011
MEDI-573# IGF mAb metastatic breast cancer II Q2 2012
AZD0156 ATM serine/threonine kinase inhibitor solid tumours I Q4 2015
AZD2811# Aurora B kinase inhibitor solid tumours I Q4 2015
AZD6738 ATR serine/threonine kinase inhibitor solid tumours I Q4 2013
AZD8186 PI3 kinase beta inhibitor solid tumours I Q2 2013
AZD9150# STAT3 inhibitor haematological malignancies I Q1 2012
AZD9496 selective oestrogen receptor downregulator (SERD) ER+ breast cancer I Q4 2014
AZD4635 A2aR inhibitor
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