REG - AstraZeneca PLC - Final Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 3

AstraZenecaAnnouncement

05/02/2015 07:11

- Part 3: For the preceding part double click  ID:nRSE1189Eb 

Faslodex, after those companies sent Paragraph IV
notices that they are seeking FDA approval to market generic versions of Faslodex prior to the expiration of AstraZeneca's
patents. In January 2015, AstraZeneca received a Paragraph IV notice from Glenmark Generics, Inc. USA (Glenmark), which is
also seeking FDA approval to market a generic version of Faslodex prior to the expiration of the same four patents, and
AstraZeneca filed a patent infringement lawsuit against Glenmark in the US District Court in New Jersey. The lawsuits
remain pending. 
 
Nexium (esomeprazole magnesium) 
 
Patent proceedings in the US 
 
As previously disclosed, in October 2014 AstraZeneca received a Paragraph IV notice from Actavis Laboratories FL, Inc.
(Actavis). Subsequently, AstraZeneca has received Paragraph IV notices from Andrx Labs, LLC (Andrx) and Perrigo Company PLC
(Perrigo). Actavis, Andrx and Perrigo are seeking FDA approval to market generic versions of Nexium 24HR (OTC) prior to the
expiration of AstraZeneca's patents listed in the FDA Orange Book with reference to Nexium 24HR. In November 2014,
AstraZeneca commenced patent litigation against Actavis in the US District Court for the District of New Jersey. In
December 2014 and in February 2015, AstraZeneca commenced patent litigation against Andrx and Perrigo, respectively, in the
same court. 
 
Seroquel XR (quetiapine fumarate) 
 
Patent proceedings in the US 
 
In October 2014, AstraZeneca received a Paragraph IV Notice from Pharmadax, Inc. and Pharmadax USA, Inc. (together,
Pharmadax) alleging that the patent listed in the FDA Orange Book with reference to Seroquel XR is invalid, unenforceable
and/or is not infringed by the Pharmadax proposed generic product. Pharmadax has submitted an Abbreviated New Drug
Application (ANDA) seeking to market quetiapine fumarate 50mg tablets. In November 2014, AstraZeneca filed a patent
infringement lawsuit against Pharmadax in the US District Court for the District of New Jersey. 
 
Patent proceedings outside the US 
 
As previously disclosed, in Germany, in November 2012, the Federal Patent Court (the Federal Court) determined that the
Seroquel XR patent was invalid. In January 2015, the Federal Court of Justice denied AstraZeneca's appeal of the November
2012 Federal Court decision. 
 
Zestril (lisinopril dihydrate) 
 
Patent proceedings outside the US 
 
As previously disclosed, in Canada, in 1996, AstraZeneca and Merck & Co., Inc., Merck Frosst Canada & Co., Merck Frosst
Canada Ltd., (together, Merck) sued Apotex Inc. for infringement of Merck's US Patent No. 1,275,350. In 2006, Apotex was
found to infringe the patent. AstraZeneca and Merck commenced a reference to determine the quantum of damages. In December
2014, the parties settled the reference. 
 
Product liability litigation 
 
Crestor (rosuvastatin calcium) 
 
As previously disclosed, AstraZeneca is defending a number of lawsuits alleging multiple types of injuries caused by the
use of Crestor, including diabetes mellitus, various cardiac injuries, rhabdomyolysis, and/or liver and kidney injuries.
The claims of 594 plaintiffs, comprising 102 California residents and 492 non-California residents, were aggregated in one
coordinated proceeding in Los Angeles, California. The claims of additional plaintiffs are waiting to be added to the
coordination. In October 2014, the coordination judge dismissed the claims of the 492 non-California plaintiffs whose
claims were in the coordinated proceeding. Plaintiffs have appealed the October 2014 order dismissing the non-California
plaintiffs from the proceeding. There are now a total of 707 plaintiffs remaining with claims pending in California state
court, and 2 plaintiffs with claims pending in the Eastern District of Kentucky. 
 
Commercial litigation 
 
Crestor Texas Attorney General litigation 
 
In January 2015, following a previously disclosed investigation by the State of Texas into AstraZeneca's sales and
marketing activities involving Crestor, AstraZeneca was served with a lawsuit in which the Texas Attorney General's Office
intervened in a state whistleblower action pending in Travis County Court, Texas. The lawsuit alleges that AstraZeneca
engaged in inappropriate promotion of Crestor and improperly influenced the formulary status of Crestor. 
 
Nexium settlement anti-trust litigation 
 
As previously disclosed, AstraZeneca is a defendant in a Multi-District Litigation class action and individual lawsuits
alleging that AstraZeneca's settlements of certain patent litigation in the US relating to Nexium violated US anti-trust
law and various state laws. A trial in the US District Court for the District of Massachusetts commenced on 20 October 2014
on certain liability issues for claims that remain in the case. On 5 December 2014, a jury returned a verdict in favour of
AstraZeneca. On 31 December, 2014, the Plaintiffs filed motions for a new trial. On 7 January 2015, Plaintiffs filed
motions for a permanent injunction. AstraZeneca opposed those motions. A hearing on the Plaintiffs' motions for a permanent
injunction is scheduled for 6 February 2015. 
 
On 10 December 2014, following the favourable jury verdict, AstraZeneca filed a motion requesting dismissal of its appeal
of the District Court's procedural decision to certify a class of end payers. On 21 January 2015, the Court of Appeals
denied AstraZeneca's request to dismiss the appeal and issued a decision affirming the District Court's class certification
ruling. 
 
The two lawsuits filed in Pennsylvania state court by various indirect purchasers of Nexium are pending. The cases are in
their initial stages. 
 
Government investigations 
 
Dutch National Competition Authority investigation 
 
As previously disclosed, in December 2011 the Dutch competition authority, the ACM, issued a report alleging that
AstraZeneca had abused a dominant position in the Netherlands by foreclosing generics of other proton pump inhibitors. In
December 2014, the ACM issued its decision dismissing the allegations against AstraZeneca and closed its file. 
 
Medco 
 
As previously disclosed, the US Attorney's Office for the District of Delaware, Criminal Division, conducted an
investigation relating to AstraZeneca's relationship with Medco and sales of Nexium, Plendil, Prilosec and Toprol-XL. In
addition, the US Attorney's Office for the District of Delaware and the US Department of Justice investigated potential
civil claims relating to the same conduct. This matter has been resolved and a provision was previously taken. 
 
9       FULL YEAR PRODUCT REVENUE ANALYSIS 
 
                                                       World        US      Europe       Established ROW    Emerging Markets  
                                                       FY 2014$m    CER%    FY 2014$m    CER                FY 2014$m           CER%    FY 2014$m    CER%    FY 2014$m    CER%  
                                                                                         %                                                                                      
 Cardiovascular and Metabolic disease:                                                                                                                                          
 Crestor                                               5,512        (1)     2,918        -                  1,200               (3)     667          (10)    727          11    
 Seloken/Toprol-XL                                     758          4       91           (31)               124                 (4)     19           (13)    524          17    
 Onglyza                                               820          119     481          82                 155                 175     59           210     125          251   
 Atacand                                               501          (16)    44           (39)               169                 (26)    43           (35)    245          5     
 Brilinta/Brilique                                     476          70      146          100                231                 40      33           106     66           133   
 Byetta                                                327          59      199          31                 81                  119     27           164     20           200   
 Bydureon                                              440          191     374          185                57                  235     5            n/m     4            100   
 Plendil                                               249          (4)     -            -                  19                  (10)    9            (10)    221          (3)   
 Tenormin                                              161          (15)    8            (47)               48                  (6)     54           (23)    51           (4)   
 Others                                                558          52      190          280                199                 14      35           48      134          12    
 Total Cardiovascular and Metabolic disease            9,802        12      4,451        17                 2,283               8       951          (3)     2,117        17    
 Oncology:                                                                                                                                                                      
 Zoladex                                               924          (4)     26           13                 226                 (12)    322          (6)     350          4     
 Iressa                                                623          (1)     -            -                  166                 (7)     177          (4)     280          6     
 Faslodex                                              720          7       340          5                  245                 10      59           3       76           14    
 Arimidex                                              298          (12)    15           150                76                  (19)    108          (24)    99           5     
 Casodex                                               320          (10)    5            -                  42                  (21)    169          (18)    104          14    
 Others                                                142          4       25           -                  33                  14      48           (13)    36           36    
 Total Oncology                                        3,027        (2)     411          7                  788                 (6)     883          (11)    945          8     
 Respiratory, Inflammation and Autoimmunity:                                                                                                                                    
 Symbicort                                             3,801        10      1,511        23                 1,462               (4)     458          17      370          22    
 Pulmicort                                             946          11      211          (6)                162                 (6)     97           (6)     476          35    
 Others                                                316          (2)     26           (55)               123                 7       27           (15)    140          19    
 Total Respiratory, Inflammation and Autoimmunity      5,063        10      1,748        15                 1,747               (4)     582          11      986          27    
 Infection, Neuroscience and Gastrointestinal:                                                                                                                                  
 Nexium                                                3,655        (4)     1,876        (12)               368                 2       606          9       805          5     
 Synagis                                               900          (15)    499          (19)               401                 (9)     -            -       -            -     
 Seroquel XR                                           1,224        (8)     738          (1)                343                 (18)    44           (35)    99           -     
 Seroquel IR                                           178          (46)    (72)         n/m                89                  (16)    36           (63)    125          (13)  
 Local Anaesthetics                                    488          -       -            -                  197                 (5)     168          (1)     123          9     
 Losec/Prilosec                                        422          (11)    28           (7)                129                 (2)     106          (30)    159          1     
 Merrem                                                253          (10)    6            (45)               32                  (35)    4            (20)    211          (3)   
 FluMist/Fluenz                                        295          20      218          10                 70                  64      7            100     -            -     
 Others                                                788          (6)     217          (24)               191                 (3)     123          (1)     257          9     
 Total Infection, Neuroscience and Gastrointestinal    8,203        (7)     3,510        (12)               1,820               (7)     1,094        (7)     1,779        3     
 Total                                                 26,095       3       10,120       4                  6,638               (1)     3,510        (4)     5,827        12    
 
 
10     FOURTH QUARTER PRODUCT REVENUE ANALYSIS 
 
                                                       World        US      Europe       Established ROW    Emerging Markets  
                                                       Q4 2014$m    CER%    Q4 2014$m    CER                Q4 2014$m           CER%    Q4 2014$m    CER%    Q4 2014$m    CER%  
                                                                                         %                                                                                      
 Cardiovascular and Metabolic disease:                                                                                                                                          
 Crestor                                               1,388        (2)     760          (2)                286                 (1)     164          (10)    178          9     
 Seloken/Toprol-XL                                     174          8       15           (21)               30                  -       4            (43)    125          19    
 Onglyza                                               200          122     101          60                 44                  n/m     17           n/m     38           n/m   
 Atacand                                               117          (7)     11           10                 36                  (30)    9            (31)    61           18    
 Brilinta/Brilique                                     133          52      43           79                 60                  25      9            50      21           118   
 Byetta                                                69           31      39           8                  20                  91      7            100     3            -     
 Bydureon                                              123          153     103          158                18                  233     1            -       1            n/m   
 Plendil                                               59           (9)     -            -                  5                   (17)    1            (67)    53           (5)   
 Tenormin                                              40           (7)     2            (33)               11                  (8)     12           (26)    15           36    
 Others                                                171          89      66           n/m                55                  40      13           150     37           23    
 Total Cardiovascular and Metabolic disease            2,474        13      1,140        15                 565                 12      237          (3)     532          21    
 Oncology:                                                                                                                                                                      
 Zoladex                                               227          (2)     8            60                 52                  (8)     83           (3)     84           1     
 Iressa                                                150          2       -            -                  42                  -       43           (9)     65           13    
 Faslodex                                              182          4       90           3                  58                  7       15           -       19           5     
 Arimidex                                              68           (15)    3            (25)               16                  (23)    27           (21)    22           5     
 Casodex                                               74           (16)    -            n/m                10                  (15)    40           (23)    24           9     
 Others                                                39           5       5            (29)               8                   -       16           -       10           67    
 Total Oncology                                        740          (2)     106          1                  186                 (4)     224          (10)    224          8     
 Respiratory, Inflammation and Autoimmunity:                                                                                                                                    
 Symbicort                                             978          5       395          13                 347                 (7)     121          2       115          25    
 Pulmicort                                             269          15      56           (5)                41                  -       28           (9)     144          39    
 Others                                                89           11      4            (75)               39                  46      6            (22)    40           32    
 Total Respiratory, Inflammation and Autoimmunity      1,336        7       455          7                  427                 (3)     155          (1)     299          32    
 Infection, Neuroscience and Gastrointestinal: