REG - AstraZeneca PLC - AstraZeneca Full-Year and Q4 2015 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 2
04/02/2016 07:10
- Part 2: For the preceding part double click ID:nRSD0427Oa
Capital Structure
At 31 December 2015, outstanding gross debt (interest-bearing loans and borrowings) was $15,053m (31 December 2014:
$10,843m). In November 2015, the Company issued a total of $6bn of notes, with the proceeds of the issue to be used to fund
corporate and business development activity, repay certain outstanding commercial paper obligations and for general
corporate purposes. Of the gross debt outstanding at 31 December 2015, $916m was due within one year (31 December 2014:
$2,446m). The Company's net debt position at 31 December 2015 was $7,762m (31 December 2014: $3,223m).
Shares in Issue
During the year, one million shares were issued in respect of share option exercises for a consideration of $43m. The total
number of shares in issue as at 31 December 2015 was 1,264 million.
Capital Allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and the
Company's shareholders. After providing for investment in the business, supporting the progressive dividend policy and
maintaining a strong, investment-grade credit rating, the Board will keep under review investment in earnings-accretive
opportunities.
Sensitivity: Foreign-Exchange Rates
The Company provides the following currency sensitivity information:
Average Exchange Rates Versus USD Impact Of 5% Weakening In Exchange Rate Versus USD ($m)2
Currency Primary Relevance FY 2015 YTD 20161 Change % Total Revenue Core Operating Profit
EUR Product Sales 0.90 0.92 (2) (178) (103)
JPY Product Sales 121.04 118.27 2 (102) (66)
CNY Product Sales 6.28 6.57 (4) (133) (62)
SEK Costs 8.43 8.54 (1) (8) 71
GBP Costs 0.65 0.69 (6) (34) 96
Other3 (201) (122)
1Based on average daily spot rates between 1 January 2016 and 29 January 20162Based on 2015 actual results at 2015 actual exchange rates3Other 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 31 December 2015,
AstraZeneca had hedged around 85% of forecast short-term currency exposure that arises between the booking and settlement
dates on non-local currency purchases and Product Sales.
Corporate and Business Development Update
___________________________________________________________________________
The highlights of the Company's corporate and business development activities since the prior results announcement on 5
November 2015 are shown below.
a) Investment in Acerta Pharma
On 17 December 2015, AstraZeneca announced that it had entered into an agreement to invest in a majority equity stake in
Acerta Pharma B.V. (Acerta), a privately-owned biopharmaceutical company based in the Netherlands and the US. The
transaction will provide AstraZeneca with a potentially best-in-class irreversible oral Bruton's tyrosine kinase (BTK)
inhibitor, acalabrutinib (ACP-196), currently in Phase II/III development for B-cell blood cancers and in Phase I/II
clinical trials in multiple solid tumours.
On 2 February 2016, on completion of the agreement, AstraZeneca acquired 55% of the entire issued share capital of Acerta
for an upfront payment of $2.5bn. A further payment of $1.5bn will be paid either on receipt of the first regulatory
approval for acalabrutinib in the US, or the end of 2018, whichever is sooner. The agreement also includes options, which
if exercised, provide the opportunity for Acerta shareholders to sell, and AstraZeneca to buy, the remaining 45% of shares
in Acerta (see Note 5).
b) Acquisition of ZS Pharma
On 6 November 2015, AstraZeneca announced that it had entered into an agreement to acquire ZS Pharma Inc. (ZS Pharma), a
biopharmaceutical company based in San Mateo, California. The transaction, completed in Q4 2015, gives AstraZeneca access
to the potassium-binding compound ZS-9. This is a potential best-in-class treatment for hyperkalaemia, a condition
associated with increased mortality in chronic kidney disease (CKD) and chronic heart failure (CHF). Under the terms of the
agreement, AstraZeneca acquired ZS Pharma for $90 per share (see Note 4).
c) Respiratory portfolio acquisition
On 16 December 2015, AstraZeneca announced that it had entered into a definitive agreement to acquire the core Respiratory
business of Takeda Pharmaceutical Company Limited (Takeda). The transaction, once completed, will include the expansion of
rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor
for the treatment of COPD.
Under the terms of the agreement, AstraZeneca will make a payment of $575m. Upon completion approximately 200 staff will
transfer to AstraZeneca.
d) Allergan - ATM-AVI
On 29 January 2016, it was announced that AstraZeneca had entered into a global agreement with Allergan plc (Allergan) to
develop and commercialise ATM-AVI, an investigational, fixed-dose antibiotic, combining aztreonam and avibactam. Together,
the two companies will evaluate the combination to treat serious infections caused by metallo β-lactamase MBL-producing
Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae, for which there are
currently very limited treatments. ATM-AVI may present a new treatment option for patients with MBL-producing pathogens.
Under the terms of the agreement, Allergan will maintain commercialisation rights in the US and Canada and AstraZeneca will
retain commercialisation rights in all other countries. AstraZeneca initiated a Phase I trial for ATM-AVI in 2012.
e) Agreement on rights to Entocort in the US
On 15 December 2015, AstraZeneca completed an agreement with Perrigo Company plc (Perrigo) for the divestment of US rights
to Entocort (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn's disease. Under the terms
of the agreement, Perrigo paid AstraZeneca $380m to acquire the rights to sell Entocort capsules and the authorised generic
Entocort capsules marketed by Par Pharmaceuticals Companies, Inc.
The transaction did not include the transfer of any AstraZeneca employees or facilities. As a divestment, the income was
recorded within Other Operating Income.
f) Strategic investments in China
On 16 December 2015, AstraZeneca announced a range of strategic initiatives to accelerate the delivery of innovative
biologics and targeted medicines to patients in China. The initiatives and investments include a strategic alliance with
WuXi AppTec, a leading Chinese biologics manufacturer and contract research organisation, to produce innovative biologics
locally in China. Under the agreement, AstraZeneca has the option to acquire WuXi AppTec's biologics manufacturing capacity
in Wuxi City in the next few years through an overall investment approximating $100m. Prior to that, WuXi AppTec remains
the Company's exclusive partner for R&D manufacturing for innovative biologics in China.
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 prior results announcement on 5 November 2015:
Regulatory Approvals 3 - Zurampic (US)- Tagrisso (US, EU)
Regulatory Submission Acceptances 3 - brodalumab (US, EU)- ZS-9 (EU)
Other Key Developments 3 - CHMP positive recommendations (EU): Zurampic, Brilique, Tagrisso
New Molecular Entities (NMEs) in Pivotal Trials or under Regulatory Review* 15 RIA- PT003* - COPD- brodalumab*- benralizumab- tralokinumab - severe asthma- PT010 - COPD- anifrolumab - lupus (SLE) CVMD- roxadustat- ZS-9* Oncology- cediranib*- tremelimumab- durvalumab - multiple cancers- acalabrutinib- moxetumomab pasudotox - leukaemia- selumetinib ING- CAZ AVI*
Projects in clinical pipeline 125
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD - Cardiovascular & Metabolic Disease, ING - Infection,
Neuroscience & Gastrointestinal
1. Respiratory, Inflammation & Autoimmunity (RIA)
Steady progress continues to be made in the RIA pipeline, which now includes six programmes in pivotal trials or under
registration. 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. The pipeline also includes a number of assets in
inflammatory and autoimmune diseases within areas such as psoriasis, systemic lupus and rheumatoid arthritis.
a) Symbicort (asthma)
Symbicort comprises budesonide (a corticosteroid, ICS) and formoterol (a long-acting beta agonist, LABA). The FDA required
all manufacturers of medicines indicated for the treatment of asthma, containing LABA-based medicines, to conduct identical
trials evaluating the safety when used in combination with an inhaled corticosteroid compared to the ICS alone.
The Symbicort LABA safety trial met its primary endpoint in the period, based on top-line results, demonstrating that the
risk of serious asthma-related events for Symbicort is no different to that of budesonide alone. The trial was a
randomised, double-blind, 26-week, active-controlled trial in 11,700 patients, aged at least 12 years of age and suffering
from asthma.
b) Zurampic (gout)
On 22 December 2015, AstraZeneca announced that the FDA had approved Zurampic (lesinurad) 200mg tablets in combination with
a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not
achieved target serum uric-acid levels with an XOI alone. The approval was based on data from three pivotal Phase III
trials, CLEAR1, CLEAR2 and CRYSTAL. These represent the largest clinical trial data set of gout patients (n=1,537) treated
with combination urate-lowering therapy.
On 18 December 2015, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorisation of Zurampic 200mg tablets.
Zurampic is recommended for the adjunctive treatment of hyperuricaemia in adult gout. Zurampic will now be reviewed by the
European Commission (EC). AstraZeneca anticipates a final decision in the first half of 2016.
c) Brodalumab (psoriasis)
During the period, regulatory submissions for brodalumab for the treatment of moderate-to-severe psoriasis were accepted in
the US and EU. The submissions were supported by data from the three AMAGINE Phase III pivotal trials. The results
indicated that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant
number of moderate-to-severe plaque psoriasis patients achieve total clearance of skin disease.
Under a collaboration agreement, Valeant Pharmaceuticals International Inc. (Valeant) has an exclusive license to develop
and commercialise brodalumab globally, except in Japan and certain other Asian countries. Valeant assumes decisions on
future development and development costs associated with the regulatory approval of brodalumab, as well as decisions on
future development.
d) Tralokinumab (IPF)
A Phase II trial for tralokinumab in idiopathic pulmonary fibrosis (IPF), a potential exploratory indication for the
medicine, was terminated in the period due to lack of efficacy on endpoints of IPF progression. No safety issues were
detected. The Phase III programme for severe asthma, the lead indication for tralokinumab, is ongoing, with top-line
results expected in 2017. Tralokinumab is anticipated to become AstraZeneca's second biologic medicine in Respiratory
diseases after benralizumab.
e) Anifrolumab (lupus)
Positive new data on anifrolumab in systemic lupus erythematosus (SLE) were presented at the American College of
Rheumatology's annual scientific meeting in San Francisco. The trial met primary and secondary endpoints in Phase II, with
anifrolumab significantly reducing lupus disease activity compared with placebo across multiple endpoints.
In line with the Company's dedication to personalised medicines, anifrolumab is being developed with an interferon-gene
signature test designed to identify patients who may be more likely to benefit from treatment. The anifrolumab Phase III
programme in SLE was initiated in July 2015 and is expected to read out with top-line results in 2018. Additional ongoing
trials include a Phase II lupus nephritis trial and a Phase I trial with a subcutaneous route of administration.
2. Cardiovascular & Metabolic Disease (CVMD)
AstraZeneca's strategy in CVMD focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk
factors across CV disease, Diabetes and CKD indications. The patient-centric approach is reinforced by science-led
life-cycle management programmes and technologies, including early research into regenerative methods.
a) Brilinta/Brilique (CV disease)
On 18 December 2015, AstraZeneca announced that the CHMP adopted a positive opinion, recommending approval of the 60mg dose
of Brilique for the treatment of patients with a history of heart attack and at high risk of having a further coronary
event. The opinion stated that treatment may be started as continuation therapy after an initial one-year treatment with
dual anti-platelet therapy. The 90mg dose of Brilique is currently indicated in the EU to reduce the rate of cardiovascular
death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome.
b) Saxagliptin/dapagliflozin (type-2 diabetes)
AstraZeneca has continued to work closely with the FDA following the receipt of a Complete Response Letter in October 2015.
The Company plans to submit additional clinical data for saxagliptin/dapagliflozin from a trial that is now completed and
anticipates a new regulatory submission in the first half of 2016.
c) ZS-9 (hyperkalaemia)
The acquisition of ZS Pharma was completed on 17 December 2015 and ZS-9 (sodium zirconium cyclosilicate), a potential
best-in-class treatment for hyperkaelemia, was accepted in the period by CHMP for regulatory review, in line with the
Company's expectations.
3. Oncology
AstraZeneca has a deep-rooted heritage in Oncology with a rejuvenating portfolio of medicines that has the potential to
transform patients' lives and the Company's future. With at least six new medicines molecular entities to be launched
between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, the Company is committed to
advance Oncology as one of AstraZeneca's six Growth Platforms, focusing on lung, ovarian, breast and blood cancers. By
exploiting the power of four scientific platforms -- immuno-oncology (IO), the genetic drivers of cancer and resistance,
DNA damage repair and antibody drug conjugates -- and by championing the development of personalised medicines
combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.
a) Faslodex (breast cancer)
On 29 January 2016, the Company received notification that the FDA had accepted for regulatory submission a supplemental
new drug application (sNDA) for Faslodex. The aim of the sNDA is to supplement the currently-approved indication for
Faslodex to encompass the positive results of the Phase III PALOMA-3 trial. This trial tested adding Ibrance (palbociclib)
to Faslodex versus Faslodex alone in women with HR-positive, HER2-negative metastatic breast cancer. The trial was
conducted by Pfizer Inc., in collaboration with AstraZeneca.
b) Lynparza (ovarian and other cancers)
In January 2016 Breakthrough Therapy designation was granted by the FDA for Lynparza for prostate cancer patients with
BRCA1/2 or ATM gene-mutated metastatic castrate-resistant prostate cancer (mCRPC) who have received previous taxane-based
chemotherapy and one newer hormonal agent (abiraterone or enzalutamide). Accompanying this designation, Lynparza received a
positive Phase III investment decision in the period from the Company for development in mCRPC.
These developments highlighted Lynparza's significant future potential, in addition to the approved use in treating
patients with a particular form of ovarian cancer.
c) Tagrisso (lung cancer)
On 13 November 2015, Tagrisso was approved by the FDA for patients with epidermal growth factor receptor (EGFR) T790M
mutation-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on an EGFR tyrosine kinase inhibitor
(TKI). This followed one of the fastest medicine-development programmes in history, from the start of clinical trials to
approval in two years and eight months. Tagrisso provides an important new option for patients, with an objective response
rate of 59% and a median duration of response of over one year.
On 3 February 2016, Tagrisso received conditional approval in the EU for the treatment of adult patients with
locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is the first T790M-directed inhibitor to
receive marketing authorisation by the EU. Tagrisso's indication includes patients with T790M NSCLC regardless of previous
treatment with an EGFR TKI, underlining the unmet medical need in the small number of EGFR-mutated NSCLC patients who are
initially (de novo) diagnosed with the T790M mutation. The approval follows the positive opinion received on 18 December
2015.
Interactions with regulatory authorities in the rest of the world, including the accelerated review process in Japan, are
ongoing.
The ADAURA Phase III trial in adjuvant EGFRm NSCLC began enrollment in the quarter and will measure disease-free survival.
d) Durvalumab (multiple cancers)
Monotherapy
As announced on 18 December 2015, the preliminary findings of the ATLANTIC trial supported the clinical activity of
durvalumab. In the trial of 3rd-line or later-stage NSCLC patients, durvalumab demonstrated expected clinical activity and
durable response in heavily pre-treated patients. The treatment and regulatory landscape in lung cancer is evolving
however, and the Company does not anticipate any regulatory submission as a monotherapy for 3rd-line PD-L1-positive NSCLC
patients. Durvalumab is a cornerstone of the IO portfolio, with a fast-advancing development programme focused primarily on
novel combinations.
Combination therapy
New data from the Phase Ib durvalumab + tremelimumab (durva + treme) combination trial in NSCLC were presented at the
Society for Immunotherapy of Cancer meeting in November 2015. The trial investigators presented updated safety and efficacy
results for 102 patients. In 84 of the patients evaluable for efficacy, results showed an overall response rate of 25%
(21/84, 95% CI of 16-36%), consistent with data presented at the American Society of Clinical Oncology's meeting in 2015.
Response rates did not appear dependent on PD-L1 status: 35% (PD-L1-positive), 22% (PD-L1-negative, <25% tumour-cell
staining) and 33% (PD-L1-negative, 0% tumour-cell staining). Higher response rates were observed in those patients who had
only received one prior treatment: 47% (15/32, 95% CI of 29-65%).
The CAURAL trial, combining Tagrisso and durvalumab, remains on clinical hold, based on an increase in the incidence of
interstitial lung disease, compared to what has been previously reported with each medicine used on its own. Investigation
of the safety signal is ongoing.
During the period, first patients were dosed in a number of durva + treme combination trials, including NEPTUNE, EAGLE,
KESTREL, DANUBE and ALPS as well as in the safety lead-in of the triple combination trial in NSCLC with chemotherapy.
AstraZeneca is planning a Phase III trial with durvalumab in small cell lung cancer that will include the first
IO-IO-chemotherapy triple-combination arm. A second, earlier-stage trial will also pair durvalumab with other portfolio
medicines such as Lynparza and AZD1775 (WEE-1).
The MYSTIC trial saw its primary endpoint updated to a co-primary endpoint of progression-free survival (PFS) and overall
survival. The trial is recruiting ahead of expectations and is expected to be the first IO-IO combination 1st-line NSCLC
trial to provide PFS data, in the first half of 2017.
An update on ongoing trials with durvalumab is provided over the page:
OTHER METASTATIC CANCERs Name Phase Line of treatment Population Design Timelines Status DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 First patient now dosed ALPS II 2nd line Metastatic pancreatic cancer durva + treme (single arm) FPD Q4 2015 Data expected 2017 First patient now dosed - II 2nd/3rd line Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme - In preparation - II 2nd line
Unresectable liver cancer durvalumab vs tremelimumab vs durva + treme - In preparation FPD=First Patient Dosed, LPD=Last Patient Dosed, SoC=Standard of Care, SCCHN = Squamous Cell Carcinoma of the Head and Neck
Early disease Monotherapy
ADJUVANT1 III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo FPD Q1 2015 Data expected 2020 Recruiting
PACIFIC III N/A Stage III unresectable NSCLC durvalumab vs placebo FPD Q2 2014 Data expected 2017 Recruiting; >50% of patients now randomised
Advanced/metastatic disease Combination therapy
ARCTIC III 3rd line PD-L1 neg. NSCLC durvalumab vs tremelimumab vs durva + treme vs SoC FPD Q2 2015 Data expected H1 2017 Recruiting
MYSTIC III 1st line NSCLC durvalumab vs durva + treme vs SoC FPD Q3 2015 Data expected H1 2017 Recruiting
NEPTUNE III 1st line NSCLC durva + treme vs SoC FPD Q4 2015 Data expected 2018 First patient now dosed
- III 1st line NSCLC durvalumab + chemotherapy +/- tremelimumab - First patient now dosed in safety lead-in
- III 1st line SCLC durva + treme + chemotherapy vs SoC - Awaiting first patient dosed
-
III
1st line
SCLC
durva + treme + chemotherapy vs SoC
-
Awaiting first patient dosed
1 Conducted by the National Cancer Institute of Canada METASTATIC OR RECURRENT HEAD AND NECK CANCER
Name Phase Line of treatment Population Design Timelines Status
Monotherapy
HAWK II 2nd line PD-L1 pos. SCCHN durvalumab (single arm) FPD Q1 2015 Data expected H2 2016 Recruiting Indication granted FDA Fast Track designation
Combination therapy
CONDOR II 2nd line PD-L1 neg. SCCHN durvalumab vs tremelimumab vs durva + treme FPD Q2 2015 Data expected 2017 Recruiting
EAGLE III 2nd line SCCHN durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 First patient now dosed
KESTREL III 1st line SCCHN durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 First patient now dosed
OTHER METASTATIC CANCERs
Name Phase Line of treatment Population Design Timelines Status
DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 First patient now dosed
ALPS II 2nd line Metastatic pancreatic cancer durva + treme (single arm) FPD Q4 2015 Data expected 2017 First patient now dosed
- II 2nd/3rd line Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme - In preparation
- II 2nd line Unresectable liver cancer durvalumab vs tremelimumab vs durva + treme - In preparation
FPD=First Patient Dosed, LPD=Last Patient Dosed, SoC=Standard of Care, SCCHN = Squamous Cell Carcinoma of the Head and
Neck
e) Early-stage Oncology
New Oncology programmes that progressed into human trials during the period included MEDI9197, a TLR 7/8 agonist, in solid
tumours and a GITR fusion protein, MEDI1873. Furthermore, two small-molecule programmes developed in collaboration with
BIND Therapeutics moved into clinical trials: AZD0156, a first-in-class ATM kinase inhibitor which further strengthens the
Company's leading position in DNA damage response and AZD2811, a nanoparticle formulation of a novel, selective inhibitor
of Aurora B kinase that has been shown to be active in both solid and haematological tumours.
Additionally the Company now has a HER2-targeted, bi-specific antibody drug conjugate, MEDI4276, in a Phase I trial in
solid tumours. HER2 (receptor tyrosine-protein kinase) is over-expressed in several cancers, including breast and gastric
cancers. AZD3759, an EGFR inhibitor designed to cross the blood brain barrier, progressed into Phase II expansion cohorts
in leptomeningeal disease, a form of brain cancer, and in patients with brain metastases.
ASTRAZENECA DEVELOPMENT PIPELINE 31 DECEMBER 2015
Includes AstraZeneca-sponsored or directed studies only
Phase III / Pivotal Phase II / Registration
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.
† US and EU dates correspond to anticipated acceptance of the regulatory submission.
# Partnered and/or in collaboration.
Respiratory, Inflammation and Autoimmunity
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
benralizumab#CALIMA SIROCCO ZONDA BISE BORAGREGALE IL-5R mAb severe asthma Q4 2013 H2 2016 H2 2016 N/A N/A
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 2018 2018 N/A N/A
brodalumab#AMAGINE-1,2,3 IL-17R mAb psoriasis Q3 2012 Accepted1 Accepted N/A N/A
Zurampic (lesinurad) selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout Q4 2011 Approved Accepted2
CLEAR 1,2
CRYSTAL
PT003 GFF PINNACLE LABA/LAMA COPD Q2 2013 Accepted H2 2016 2017 2017
PT010 LABA/LAMA/ ICS COPD Q3 2015 2018 2018 2017 2019
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe asthma Q3 2014 2018 2018 2018
Cardiovascular and Metabolic Diseases
Brilinta/Brilique3 P2Y12 receptor antagonist arterial thrombosis Launched Launched Accepted Launched
Epanova# omega-3 carboxylic acids severe hypertrigly-ceridemia Approved 2018 2019
Farxiga/Forxiga4 SGLT2 inhibitor type-2 diabetes Launched Launched Launched Accepted
roxadustat# OLYMPUS ROCKIES hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD/ESRD Q3 2014 2018 N/A N/A H2 20165
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia Accepted Accepted
Oncology
acalabrutinib#6 Bruton's tyrosine kinase (BTK) inhibitor B-cell blood cancers H2 2016
cediranibICON 6 VEGFR tyrosine kinase inhibitor PSR ovarian cancer Q2 2007 Accepted (Orphan Drug)
durvalumab# + tremelimumabALPS¶ PD-L1 mAb + CTLA-4 mAb metastatic pancreatic ductal carcinoma Q4 2015 2017 2017 2017
durvalumab#PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 2017 2020 2020
durvalumab# PD-L1 mAb 2nd-line SCCHN (PD-L1 positive) Q1 2015 2017(Fast Track) 2019 2019
HAWK¶
durvalumab# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 2017 2017 2017
ARCTIC
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN (PD-L1 negative) Q2 2015 2017 2019 2019
CONDOR¶
durvalumab# + tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder Q4 2015 2018 2018 2018
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN Q4 2015 2019 2019 2019
EAGLE
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line SCCHN Q4 2015 2018 2018 2018
KESTREL
durvalumab# + tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q3 2015 2017 2017 2017
durvalumab# + tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q4 2015 2019 2019 2019
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 2017(Orphan Drug) 2018
immunotoxin
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2018 2018
ASTRA
selumetinib# MEK inhibitor 2nd-line KRASm NSCLC Q4 2013 2017 2017
SELECT-1
Tagrisso (AZD9291)AURA, AURA 2 EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q2 2014 Launched(Breakthrough designation, Priority Review, Orphan Drug) Approved7 (Accelerated assessment) Accepted(Priority Review) 2017
Tagrisso (AZD9291)AURA 3 EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q3 2014 2017 2017 2017
tremelimumab¶ DETERMINE CTLA-4 mAb mesothelioma Q2 2014 H2 2016(Orphan Drug, Fast Track) H2 2016 H2 2016
Infection, Neuroscience and Gastrointestinal
CAZ AVI# cephalosporin/beta lactamase inhibitor serious infections, complicated intra-abdominal infection, complicated urinary tract infection Q1 2012 N/A Accepted 2017
CAZ AVI# cephalosporin/ beta lactamase inhibitor hospital-acquired pneumonia/ ventilator-associated pneumonia Q2 2013 N/A Accepted 2017
MEDI-550 pandemic influenza virus vaccine pandemic influenza prophylaxis N/A H1 20168 N/A N/A
Zinforo# extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia/skin infections N/A Launched N/A Submitted
¶ Registrational Phase II/IIItrial.1 US regulatory
submission accepted Q1 2016.2 CHMP Positive Opinion received
December 2015.3 Brilinta in the US; Brilique in rest of
world.4 Farxiga in the US; Forxiga in rest of world.5
Rolling NDA submission to be initiated in H2 2016.6
Completion of the agreement with Acerta Pharma Q1 20167 CHMP
Positive Opinion received December 2015. Approval received Q1
2016.8 MAA submitted December 2015. Regulatory acceptance
anticipated H1 2016.
N/A
Zinforo#
extended spectrum cephalosporin with affinity to penicillin-binding proteins
pneumonia/skin infections
N/A
Launched
N/A
Submitted
¶ Registrational Phase II/IIItrial.1 US regulatory submission accepted Q1 2016.2 CHMP Positive Opinion received
December 2015.3 Brilinta in the US; Brilique in rest of world.4 Farxiga in the US; Forxiga in rest of world.5
Rolling NDA submission to be initiated in H2 2016.6 Completion of the agreement with Acerta Pharma Q1 20167 CHMP
Positive Opinion received December 2015. Approval received Q1 2016.8 MAA submitted December 2015. Regulatory acceptance
anticipated H1 2016.
Phases I and II
NMEs and significant additional indications
Respiratory, Inflammation and Autoimmunity
abediterol (AZD0548) LABA asthma/COPD II Q4 2007
anifrolumab# IFN-alphaR mAb lupus nephritis II Q4 2015
AZD7594 inhaled SGRM asthma/COPD II Q3 2015
AZD7624 inhaled P38 inhibitor COPD II Q4 2014
AZD9412# inhaled interferon beta asthma/COPD II Q3 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
MEDI-551# CD19 mAb neuromyelitis optica1 II Q1 2015
MEDI2070# IL-23 mAb Crohn's disease II Q1 2013
abrilumab# alpha(4)beta(7) mAb Crohn's disease / ulcerative colitis II Q4 2012
MEDI9929# TSLP mAb asthma / atopic dermatitis II Q2 2014
PT010 LABA/LAMA/ICS asthma II Q2 2014
RDEA3170 selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout II Q3 2013
tralokinumab IL-13 mAb atopic dermatitis II Q1 2015
anifrolumab# IFN-alphaR mAb systemic lupus erythematosus (subcutaneous) I Q4 2015
lesinurad+allopurinol selective uric acid reabsorption inhibitor (URAT-1)+xanthine oxidase inhibitor chronic treatment of hyperuricemia in patients with gout I Q4 2015
AZD1419# TLR9 agonist Asthma I Q3 2013
AZD7986 DPP1 COPD I Q4 2014
AZD8871 MABA COPD I Q4 2015
AZD8999 MABA COPD I Q4 2013
AZD9567 oral SGRM rheumatoid arthritis I Q4 2015
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI5872# B7RP1 mAb systemic lupus erythematosus I Q4 2008
MEDI7836 IL-13 mAb-YTE Asthma I Q1 2015
Cardiovascular and Metabolic Diseases
AZD4076 anti-miR103/107 oligonucleotide non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH) I Q4 2015
MEDI6012 LCAT ACS II Q4 2015
MEDI0382 GLP-1/glucagon dual agonist diabetes / obesity I Q1 2015
MEDI4166 PCSK9/GLP-1 mAb + peptide fusion diabetes / cardiovascular I Q4 2015
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
Oncology
AZD1775# WEE-1 inhibitor
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