Expiring patents threaten lucrative statins
drug market intensified after Merck and Schering-Plough joined
forces to win Food and Drug Administration (FDA) approval for their
new entrant, Vytorin.
The two drug companies plan to invest substantial sums behind an increasingly popular move that drug companies are participating in. In an attempt to extend ageing franchise, the trend now is to combine two existing drugs into one pill.
Vytorin is a blend of Merck's Zocor, one of the popular treatments known as statins, and another cholesterol-lowering product the two drug giants already co-market, Zetia. The companies claim the two-drug combo will offer the most potent cholesterol-lowering therapy yet.
In addition, if Merck can switch Zocor patients to the new treatment that will be under patent protection through the middle of 2015, it will lessen the impact of generic Zocor competition in the US, which should become available in 2006.
The cholesterol-lowering drug sector is the single biggest market in the $492 billion (€404 billion) global prescription-drug business with sales growing at a rate of 15 per cent each year. With the US government recommending even lower targets for LDL, the bad cholesterol, for high-risk patients, sales are likely to rocket.
Merck and Schering-Plough face difficult competition from Pfizer which dominate the market with its $10 billion Lipitor, and AstraZeneca which is struggling to establish its own statin, Crestor.
Greg Duncan, vice-president for U.S. product marketing at Pfizer, commented that Vytorin combination does not yet have the proven safety record nor data to suggest it could save lives, unlike Lipitor.
Market giant Lipitor could face generic rivals as early as 2011. Pfizer hopes to avoid disaster by developing a drug combining Lipitor with a compound that raises HDL, or good cholesterol. If this product wins approval and Pfizer can switch large numbers of patients to the new combo, the sting from Lipitor generics will be lessened.
