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New Anti-Lipid Fixed Combination 'Power Pill' - Abbott and AstraZeneca forge lipid pact
US group Abbott Laboratories and Anglo-Swedish drug major AstraZeneca have linked arms to develop a new power pill targeting the three blood lipids that play a major role in heart disease - LDL-C, or 'bad' cholesterol, HDL-C, or 'good' cholesterol, and triglycerides - in a move which could ultimately give birth to a new standard of treatment for patients with complex lipid disease.
The drugmakers are planning to carry out two parallel development programmes, one assessing a fixed combination of AstraZeneca's Crestor (rosuvastatin) and Abbott's TriCor (fenofibrate) and the other a combo of Crestor and ABT-335, Abbott's next-generation fenofibrate currently in Phase III evaluation. Only one of the two programmes will be selected for final development on the back of these initial studies, the groups said in a statement.
The importance of tackling these three lipids in the prevention of heart disease, in particular raising levels of HDL-C, is really just starting to hit home. TriCor and Crestor are both lipid-regulating agents, the former boosting HDL-C while reducing triglycerides and the latter cutting down LDL-C, so this combination would offer all these actions in a single pill, potentially inducing better patient compliance and treatment outcomes.
If it makes it to market, such a drug could have huge potential, given that more than 38 million Americans have complex lipid disease and the cholesterol market is currently valued at $17 billion, of which 15% is made up of the fast-growing segment of overall cholesterol management, the firms noted.
Under the terms of the deal, all development costs and profits over the course of the partnership will be broadly shared. Abbott will carry out the clinical trial programme and is responsible for regulatory registration of the new therapy, while AstraZeneca will hold the New Drug Application. If the trials are successful, the companies are targeting a regulatory submission in 2009.
Shortly after the news emerged, Irish drugmaker Elan said it has granted Abbott US rights to use its proprietary NanoCrystal Technology in the development of the TriCor/Crestor combo. In return, Elan will receive payments based on development, clinical and regulatory milestones for the new product, as well as royalties on future sales in the US.
Clinical trial backs Crestor over rival statins
The results of a clinical trial involving nearly 2,000 patients suggest that AstraZeneca's Crestor is more effective in getting patients with high cholesterol to their treatment goals than two big-selling rivals.
The MERCURY II study found that Crestor (rosuvastatin) was more effective than either Pfizer's Lipitor (atorvastatin) or Merck & Co's Zocor (simvastatin) at both reducing low-density lipoprotein or 'bad' cholesterol and bringing patients to their target LDL cholesterol goals, as laid down by Adult Treatment Panel (ATP) III guidelines.
The data could help Crestor in its bid to win market share in the hugely lucrative statin market from Lipitor, currently the top-selling drug in the world with 2005 sales of over $12 billion, although both these products are likely to come under pressure in the latter half of this year with both Zocor and Bristol-Myers Squibb's Pravachol (pravastatin) losing patent protection in the USA.
Faced with the genericisation of the statin market, the top players will be hoping that robust data on meeting treatment goals will help offset the effects of generic competition by ensuring that their products are used in favour of generics in patients that need potent cholesterol-lowering treatment.
MERCURY II enrolled patients at high or very high risk of developing cardiovascular disease because of their elevated blood cholesterol levels, and looked at the effect of switching them from Lipitor or Zocor to Crestor after eight weeks' treatment.
At the end of a second eight-week treatment period, 43% of those switched from Lipitor 10mg to Crestor 10mg met their ATP targets, compared to 22% of those who stayed on the Pfizer drug. 53% of those on Lipitor 20mg who switched to the same dose of Crestor met their targets, compared to 35% of those who stayed on their initial therapy.
16% of patients taking Zocor 20mg met ATP goals, but this increased to 40% if they were switched to Crestor 10mg, while the corresponding proportions were 34% and 53%, respectively, for those switched from Zocor 40mg to Crestor 20mg.
Meanwhile, Pfizer also launched a broadside at its generic rivals after revealing economic data suggesting that Lipitor achieves greater reductions in heart attacks, strokes and cardiovascular procedures than Zocor, providing cost savings for healthcare payors in long-term hospitalizations and surgical costs.
"Even if the current US price of Zocor were reduced by 75%, Lipitor patients could still achieve better cardiovascular outcomes at an increase to payors of less than one dollar a day," said Dr Gregg Larson, vice president cardiovascular medical at Pfizer.
A summary of the data is published in the current issue of the journal Circulation.
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