Gastrointestinal

Therapy area world market (MAT/Q3/09)

The GI world market is valued at $39 billion, with the PPI market accounting for $26 billion

In the West (ie Europe and North America) between 10-20% of adults suffer from GERD. The prevalence of GERD in Asia is lower, but increasing. Despite effective PPI treatments, around 40% of patients do not achieve full relief from symptons.

39bn The GI world market is valued at $39 billion, with the proton pump inhibitor market accounting for $26 billion

Nexium (esomeprazole) is the first proton pump inhibitor (PPI) for the treatment of acid-related diseases to offer clinical improvements over other PPIs and other treatments.

Losec/Prilosec (omeprazole) is used for the short-term and long-term treatment of acid-related diseases.

Entocort (budesonide) is a locally acting corticosteroid for the treatment of inflammatory bowel disease.

We aim to maintain our strong position in gastrointestinal (GI) treatments by continuing to focus on PPIs. New Nexium line extensions include prevention of re-bleeding in patients with peptic ulcer bleeding and prevention of low-dose aspirin associated peptic ulcers. Our R&D is focused on finding new, innovative ways for treating acid-related disease.

Our focus

Our key marketed products

Nexium is marketed in approximately 100 countries and is available in oral (tablet/capsules and oral suspension) and intravenous (i.v.) dosage forms for the treatment of acid-related diseases. Nexium is an effective short-term and long-term therapy for patients with gastro-oesophageal reflux disease (GERD). Nexium is also approved for the treatment of GERD in children one to 17 years of age. For the treatment of active peptic ulcer disease, seven-day Nexium triple therapy (in combination with two antibiotics for the eradication of H.pylori) heals most patients without the need for follow-up anti-secretory therapy. In Europe and other markets, Nexium is approved for the healing and prevention of ulcers associated with NSAID therapy, including cyclooxygenase 2 selective inhibitors. In the US, Nexium is approved for reducing the risk of gastric ulcers associated with continuous NSAID therapy in patients at risk of developing gastric ulcers. Nexium is also approved in the US, the EU, Canada and Australia for the treatment of patients with the rare gastric disorder, Zollinger-Ellison syndrome. Following treatment with Nexium i.v., oral Nexium is approved in the EU and other markets for the maintenance of haemostasis and prevention of re-bleeding of gastric or duodenal ulcers.

Nexium i.v., which is used when oral administration is not suitable for the treatment of GERD and upper GI side effects induced by NSAIDs, is approved in 86 countries including the US and all EU countries. Nexium i.v. is also approved in the EU and other markets for the short-term maintenance of haemostasis and prevention of re-bleeding in patients following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

Losec/Prilosec was first launched in 1988 and is approved for the treatment of GERD. We continue to maintain certain patent property covering Losec/ Prilosec.

Losec/Prilosec is available both as a prescription-only medication and, in some countries, as an OTC medication where it offers consumers a more effective self-medication option for the treatment of heartburn compared to antacids and H2 receptor antagonists. In 2009, an agreement to license rights for Losec for OTC use to Bayer Consumer Care AG was announced. This agreement will extend the number of markets in which Losec is available as an OTC product.

In November, the FDA issued a Public Health Advisory to consumers and Information for Healthcare Professionals about the label update to Plavix™ (clopidogrel) about interactions with Prilosec and Prilosec OTC and potentially with other medicines that inhibit the CYP2C19 enzyme, including Nexium. AstraZeneca has full confidence in the overall benefit/risk and safety profile of Losec/Prilosec and Nexium. We will continue to evaluate thoroughly the safety and effectiveness of Losec/Prilosec and Nexium in accordance with AstraZeneca's procedures. AstraZeneca is involved in ongoing dialogue with the FDA, the EMEA and the CHMP about any pharmacological interaction and its clinical relevance.

Entocort is approved for the treatment of two types of inflammatory bowel disease. Entocort capsules are approved for use both as an acute treatment of and for maintenance of remission for mild to moderate Crohn's disease. Entocort enema is approved in some markets for the treatment of ulcerative colitis. Entocort has better tolerability compared to other corticosteroids in the treatment of both conditions. In Crohn's disease, Entocort also has greater efficacy than aminosalicylic acid medicines.

Clinical studies of key marketed products

Data from the LOTUS study (a multinational, randomised study of 554 patients) in which Nexium was compared to surgery for the management of GERD has now reported five years of follow-up. The results show that both therapies are very effective, with proportions of patients still in remission above 90% and with both therapies being well tolerated. The paediatric GERD programme in the youngest age group of zero to one year of age has been completed and submissions to regulatory authorities have commenced.

AstraZeneca conducted two studies, OBERON and ASTERIX, to evaluate the safety and efficacy of Nexium in the prevention of gastric and/or duodenal ulcers in patients who take low-dose aspirin (acetylsalicylic acid (ASA)) (75-325mg) continuously during the studies, which is defined as at least five days per week. The results of these studies are described in more detail in the Cardiovascular section. In April 2009, AstraZeneca submitted an sNDA for the low-dose ASA (75-325mg) indication for Nexium and an NDA for the new product Axanum based upon the findings in these studies.

In the pipeline

Our research activities focus on reflux inhibitors and hypersensitivity therapy. Our lead compound, lesogaberan (AZD3355), is undergoing clinical studies in Phase II. Follow-up compounds are in different stages up to Phase II testing.

Detailed information about material legal proceedings relating to our GI products can be found in Note 25 to the Financial Statements.

Performance 2009

Reported performance

GI sales for 2009 were down 5% on a reported basis to $6,011 million from $6,344 million in 2008.

Performance - CER growth rates

GI sales fell by 2% at CER.

Global Nexium sales were down 1% to $4,959 million from $5,200 million the previous year. The decline was driven by the decrease in the US of 9% to $2,835 million, however this was largely mitigated by sales outside the US increasing by 9% to $2,124 million. In the US, dispensed retail tablet volumes decreased by less than 1% despite increased generic and OTC competition. In respect of Nexium, there was growth in Canada (11%), Western Europe (7%) and Emerging Markets (15%).

For the full year, sales of Losec/Prilosec fell 10% to $946 million. Prilosec sales in the US were down 63% as a result of continued generic erosion. Outside the US, Losec sales were flat, despite increases in China (21%) and Japan (8%).

Performance 2008

Reported performance

GI sales for 2008 were down 2% on a reported basis to $6,344 million from $6,443 million in 2007.

Performance - CER growth rates

GI sales fell by 4% at CER. Growth in Canada (9%), Japan (5%) and Emerging Markets (20%) more than offset the 5% decline in sales in our Western Europe markets.

Nexium sales were down 2%, excluding the effects of exchange, to $5,200 million from $5,216 million the previous year. The decline was driven by the decrease in the US of 8% to $3,101 million, however, this was largely mitigated by sales outside the US increasing by 9% to $2,099 million. In the US, dispensed retail tablet volumes increased (2%) and Nexium was the only major PPI brand to do so in 2008.

For the full year, sales of Losec/Prilosec fell 14% to $1,055 million. Prilosec sales in the US were down 25% as a result of generic competition for the 40mg dosage form in the second half of the year. Outside the US, Losec sales declined by 11%, despite increases in China (19%) and Japan (5%).