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Developments in the Statin Market


According to IMS Health's Therapy Areas Sales Report, the cholesterol and triglyceride reducer (C10A) market increased by over 23% in 1999, amounting to $10.44 billion.

IMS Health estimates that by 2003 this market will have grown to $16 billion. The current market leader is Lipitor (atorvastatin), from Warner-Lambert and Pfizer, but AstraZeneca has what it describes as a 'superstatin' in phase III trials.

Whereas drugs like Lipitor, Merck & Co's Zocor (simvastatin) and Bristol-Myers Squibb's Pravachol (pravastatin) are referred to as first-generation statins, newer, or 'second-generation' statins are hot on their heels. Such second-generation statins, if successful, are likely to be 'megabrands' of the future for the companies concerned.

In 1999 for example, Lipitor accounted for 27.5% of the total cholesterol and triglyceride market, with sales of almost $3 billion ($2.87 billion), up from a market share in 1998 of 20.8% and sales of $1.76 billion, according to IMS Health.

AstraZeneca's 'Superstatin'

AstraZeneca is one of the companies with a second-generation or 'super' statin, ZD 4522 (licensed from Shionogi), in its pipeline, in phase III trials. Dr Tom McKillop, CEO of AstraZeneca told IMS Health, "We believe ZD 4522 has a fantastic profile and that it is significantly better than Lipitor." More of this interview with Dr McKillop can be found in IMS Health's Pharmaceutical Company Profile on AstraZeneca.

Data from head-to-head trials of ZD 4522 versus Lipitor were presented at an R&D meeting held by AstraZeneca in December 1999. According to these studies, 40mg ZD 4522 demonstrated low-density lipoprotein ('bad') cholesterol lowering of around 60-70% from baseline, versus the 40-50% achieved by 40mg Lipitor.

ZD 4522 also demonstrated impressive high-density lipoprotein ('good') cholesterol elevating ability and a clean side effect profile (i.e. no evidence of liver enzyme elevation). According to AstraZeneca, this profile represents an impressive advance over existing statins.

In the view of brokers Morgan Stanley Dean Witter, given the current mega sales of Lipitor, ZD 4522 represents a sizeable potential for AstraZeneca - some analysts are projecting peak sales as high as $3 billion.

Indeed, analysts have suggested that if successful, ZD 4522 could restrain Lipitor's global peak sales in 2005 to perhaps $6 billion, instead of the $8.5 billion otherwise projected. Nevertheless, Lipitor is still set to overtake AstraZeneca's ulcer drug Losec/Prilosec (omeprazole) as the world's top-selling prescription pharmaceutical.

16 March 2000, Copyright IMS Health

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