Therapeutic focus - Astra's COPD approval to inflate respiratory sales for now

The approval of AstraZeneca’s Symbicort for the chronic lung disease COPD in the US late Friday should help guarantee a few more years of sales growth for the drug, and help it compete more effectively with GlaxoSmithKline’s similar product Advair.

However, total sales of respiratory products, as a therapy area, is set to diminish from 2011, as the patents start to expire for both Advair and Symbicort, plus Merck & Co’s Singulair, all of which have been multi billion dollar products for several years (see tables below). As such, this COPD approval could be the last boost these ageing blockbusters receive, before the next wave of respiratory drugs starts to come through.

The table below shows that as a therapy area, respiratory is certainly not a growth area, as new products fail to overcome the loss of several blockbusters in the coming years.

WW Rx & OTC Sales by therapy area WW annual sales ($m) CAGR (08 - 14)
2008 2014
Oncology & Immunomodulators 67,162 101,740 7%
Systemic Anti-Infectives 69,101 95,215 5%
Central Nervous System 92,965 83,227 (2%)
Cardiovascular 79,287 66,370 (3%)
Musculoskeletal 40,245 60,628 7%
Endocrine 33,577 50,477 7%
Blood 40,254 45,433 2%
Respiratory 42,662 41,863 (0%)
Gastro-Intestinal 31,135 27,100 (2%)
Genito-Urinary 24,944 26,172 1%
Sensory Organs 11,348 13,953 4%
Dermatology 10,020 12,639 4%
Various 12,032 17,037 6%
Other Rx & OTC Pharma 87,535 125,758 6%
Total WW Rx & OTC Sales 642,268 767,612 3%

In 2011, the loss of patent protection for Advair, which generated sales of $7.66bn last year, means Glaxo is on the way to losing its crown of being the world’s biggest respiratory player. By 2014, analysts project that Boehringer Ingelheim will be in the number one spot, lifted by climbing sales of the anti-cholinergic Spiriva.

The product, which is only approved for COPD, has grown strongly since it was launched in 2002. Sales reached $3.0bn last year, and are seen climbing to $5.4bn in 2014, forecasts that make it the seventh fastest growing product across all therapies areas in that period.

Total Respiratory Market - Company Rankings WW annual sales ($m) CAGR (08 - 14) Market Share Market Rank
2008 2014 2008 2014 2008 2014
1 Boehringer Ingelheim 5,517 8,179 7% 12.9% 19.5% 2 1
2 GlaxoSmithKline 10,768 6,909 (7%) 25.2% 16.5% 1 2
3 Schering-Plough 3,557 3,644 0% 8.3% 8.7% 5 3
4 AstraZeneca 4,128 2,754 (7%) 9.7% 6.6% 4 4
5 Novartis 813 2,079 17% 1.9% 5.0% 8 5
6 Sanofi-Aventis 2,655 1,628 (8%) 6.2% 3.9% 6 6
7 Genentech 774 1,191 7% 1.8% 2.8% 10 7
8 Teva Pharmaceutical Industries 778 1,147 7% 1.8% 2.7% 9 8
9 Reckitt Benckiser 771 1,112 6% 1.8% 2.7% 11 9
10 Merck & Co 4,337 1,036 (21%) 10.2% 2.5% 3 10

Losing Singulair will mean Merck & Co plummets from number three to number ten by 2014. Teva, which will make the generic version, climbs to number eight.

For AstraZeneca, the COPD approval means it might be able to hold on to its number four spot, despite disappointing news from a phase III paediatric asthma product, unit dose budesonide last week which removed a key potential extension to the budesonide franchise (MAP gasping for breath after UDB failure, February 24, 2009).

The actual impact of the approval for Symbicort in COPD will be hard to judge as the company will not split out sales of asthma and COPD; Glaxo does not for Advair either. However, some analysts believe the new indication could come to represent up to 40% of annual sales (Event – Symbicort COPD approval could breathe life into sales February 17, 2009).

The rising incidence of COPD means the newer muscarinic antagonists like Spiriva are going to provide the growth for the respiratory therapy area, whilst the bronchodilators and corticosteroids like Advair and Seretide provide the drag.

Respiratory sub-categories WW annual sales ($m) CAGR (08 - 14)
2008 2014
           Anti-cholinergics  4,444  7,757  10%
           Corticoids  6,268  5,034  (4%)
           B2 stimulants  3,099  3,352  1%
           Anti-leukotrienes  5,036  1,805  (16%)
           Non-steroidal respiratory anti-inflammatories  92  98  1%
           Other bronchodilators  10,273  8,193  (4%)
      Bronchodilators  29,212  26,238  (2%)
           Anti-histamines  6,039  4,573  (5%)
           Nasal & Throat preparations  3,366  4,367  4%
           Other respiratory  4,047  6,685  9%
 Total Respiratory Market 42,662 41,863 (0%)

Key drugs in development include LAS 34273 from Almirall and Forest Laboratories, the future of which remains very uncertain after disappointing phase III results (Almirall resuscitates ailing COPD drug, October 15, 2008). Analysts believe QVA149 from Novartis and Britain's Vectura holds a great deal of potential; if phase III trials are a success, forecasts are likely to climb significantly, however results will probably not become available until 2010 at the earliest. Meanwhile, coming late to the beta 2 agonist & corticosteroid combination field is Abbott Laboratories and SkyePharma's Flutiform, a product which polarises many analysts, and should be filed with the FDA any day now. Another controversial contender is Nycomed's Daxas, a product with a chequered development history from a class of drug that has so far failed to produce a success in any respiratory indication (Nycomed to give Daxas another shot on goal, October 28, 2008).

Repiratory Market : key marketed and late-stage pipeline products WW annual sales ($m)
Phase Rank Product Company Pharmacological Class Patent Expiry 2008 2010 2012 2014
Marketed  1   Spiriva   Boehringer Ingelheim   Muscarinic antagonist  30-Jan-2018  3,036  3,566  4,403  5,353
 2   Seretide/Advair   GlaxoSmithKline   Beta 2 agonist & corticosteroid  03-Sep-2011  7,658  7,828  6,862  4,506
 3   Symbicort   AstraZeneca   Beta 2 agonist & corticosteroid  07-Oct-2014  2,004  2,328  2,214  1,947
 4   Nasonex   Schering-Plough   Corticosteroid  27-Jul-2014  1,155  1,202  1,196  1,158
 5   Combivent   Boehringer Ingelheim   Muscarinic antagonist & beta 2 agonist  09-Jun-2015  917  926  1,021  1,125
 6   Singulair   Merck & Co   Leukotriene D4 antagonist  03-Aug-2012  4,337  4,725  3,517  1,036
 7   Xolair   Genentech   Anti-IgE MAb  20-Jun-2017  517  625  726  835
 8   Flixotide/Flovent   GlaxoSmithKline   Corticosteroid  14-May-2004  1,253  953  858  764
 9   ProAir HFA   Teva Pharmaceutical Industries   Beta 2 agonist  -  363  551  605  660
 10   Atrovent HFA   Boehringer Ingelheim   Muscarinic antagonist  17-Nov-2007  428  433  480  531
Filed  1   Indacaterol (QAB149)   Novartis   Beta 2 agonist  -  -  47  235  356
 2   Bilastine   Faes Farma   Anti-histamine  -  -  23  94  176
 3   Bronchitol   Pharmaxis   Respiratory agent  23-Feb-2015  2  40  100  160
 Phase III  1   Flutiform   Abbott Laboratories   Beta 2 agonist & corticosteroid  31-Dec-2019  -  53  204  383
 2   LAS 34273   Forest Laboratories   Muscarinic M3 antagonist  30-Sep-2020  -  25  144  326
 3   Daxas   Nycomed   Phosphodiesterase IV inhibitor  27-Jan-2015  -  71  170  277
Phase II  1   QMF149   Novartis   Beta 2 agonist & corticosteroid  -  -  -  89  303
 2   642444   GlaxoSmithKline   Beta 2 agonist  -  -  -  73  143
 3   Aerosurf   Discovery Laboratories   Lung surfactant  -  -  -  46  106

Related Topics

Share This Article