[This is a bizarre PR in that it avoids any mention whatsoever of the actual data. Nevertheless, the market figured it out, sending ABT’s shares down 7% to a new 12-month low. TriCor does not bear all of the blame, however, as ABT also reported today on an experimental drug called Simdax.]
>> Abbott Statement on FIELD Study Presented at American Heart Association Meeting and Published in The Lancet
Monday November 14, 9:03 am ET
ABBOTT PARK, Ill., Nov. 14 /PRNewswire-FirstCall/ -- In response to data on the FIELD trial being presented at a late-breaking session of the American Heart Association annual meeting and published in The Lancet, Abbott issued the following statement:
The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study was conducted to determine whether early intervention with fenofibrate could prevent cardiovascular events in patients with type 2 diabetes. FIELD is the largest prospective study examining the effects of a cholesterol-lowering medication on cardiovascular outcomes in an exclusively diabetic population. Patients with type 2 diabetes are at three to four-fold risk for developing cardiovascular disease versus people without diabetes.
"FIELD provides important learnings on the role of early intervention with fenofibrate," said Dr. Anthony Keech, University of Sydney, Australia, and FIELD primary investigator. "Type 2 diabetes affects nearly 20 million Americans placing them at high risk for cardiovascular disease. The results of FIELD will add to the growing body of knowledge of how best to manage cardiovascular risks within this patient population."
About FIELD
The FIELD study is endorsed by the National Heart Foundation of Australia, Diabetes Australia, the New Zealand Society for the Study of Diabetes and the Finnish Diabetes Association. The FIELD study was conducted at 63 sites in Australia, Finland and New Zealand and was coordinated independently of the sponsors by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia. Fournier Pharma of Dijon, France, is the main sponsor of FIELD and supplier of the fenofibrate and matching placebo medication. Fenofibrate was discovered and developed by Fournier Pharma and is approved for use in nearly 80 countries worldwide, registered as Lipanthyl® and Lipidil® in most areas outside of the United States. Fournier Pharma was acquired by the Belgian company Solvay in 2005.
Indication and Important Safety Information - TriCor (fenofibrate) tablets
Fenofibrate, marketed by Abbott as TriCor in the United States, is used in addition to appropriate diet to treat adults with high cholesterol and/or mixed dyslipidemia with or without elevated triglycerides (TG), after results of lifestyle changes are unsuccessful. TriCor reduces elevated LDL cholesterol ("bad" cholesterol), total cholesterol, TGs and apolipoprotein B, and increases HDL cholesterol ("good" cholesterol). TriCor, in addition to appropriate diet, is also used to treat adults with high TGs. Excessive body weight, drinking alcohol, diseases such as diabetes and hypothyroidism, and various drugs can contribute to high TG levels and these should be assessed by a doctor before a patient takes TriCor. <<
[Using either TriCor or ABT’s next-generation fibrate called ABT-335 as the HDL-raising portion of the combo therapy, this collaboration has two ways to win. ABT announced its intention to develop TriCor in combination with an unnamed statin nine months ago (#msg-8177340). Now we know which statin they were talking about.]
>> AstraZeneca and Abbott plan combo cholesterol pill
Wed Jul 5, 2006 1:09 PM ET By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON, July 5 (Reuters) - AstraZeneca Plc < AZN > and Abbott Laboratories Inc. < ABT > are to co-develop a new two-in-one cholesterol pill, using the British firm's Crestor drug and a next-generation version of Abbott's TriCor.
The programme is the latest example of drug companies trying to develop more effective and targeted cholesterol treatments.
The partners, who will share development costs and profits, hope to have the fixed-dose combination medicine ready for U.S. regulatory submission in 2009.
The new product is designed to cut levels of "bad" LDL cholesterol and triglycerides, while boosting "good" HDL cholesterol. It will compete with Merck & Co Inc. < MRK > and Schering-Plough Corp.'s < SGP > Vytorin, which also combines two ingredients in a single cholesterol treatment.
Cholesterol-lowering medicines are the largest-selling drug class in the world, with sales totalling $29 billion in the year to April in the 13 leading markets, according to healthcare information company IMS Health.
But competition is intense, with new treatments in the works at several firms, while generics erode prices of older products.
Abbott's next-generation fenofibrate drug, ABT-335, which is currently in final Phase III clinical trials, will be used for the project. In parallel, however, a combination based on the U.S. group's existing fibrate TriCor and Crestor will also be evaluated, with final selection between the two programmes made based upon data generated from initial studies.
Speculation over the potential for creating a Crestor-based combination drug was fuelled last month after clinical trials showed that combining Crestor with Zetia -- one of the components of Vytorin -- cut LDL by an unprecedented 70 percent.
LONG-TERM POTENTIAL
Tony Zook, head of AstraZeneca's North American operations, said the project was a major opportunity to broaden Crestor's long-term commercial potential.
Industry analysts initially estimated Crestor would generate annual sales of $3 billion to $4 billion. But it has not taken off as quickly as projected, and sales totalled $1.27 billion last year.
Crestor, like Pfizer Inc.'s < PFE > Lipitor and Merck's Zocor -- which recently lost U.S. patent protection -- belongs to a class of medicines known as statins.
Abbott's products ABT-335 and TriCor are fibrates, which have been shown to raise HDL cholesterol and reduce triglycerides, a form of fat or lipid obtained through food. The combination of the two drug types should therefore address three elements in a single pill, reducing the risk of heart attack and strokes in patients with lipid disorders.
Dr. Peter Jones, an associate professor of medicine at Baylor College of Medicine in Houston who is involved with clinical trials for the combination product, said many patients needed more than statins could offer.
"There's no question there is a great need, from a physician standpoint, to treat patients for combined lipid abnormalities, and being able to find an efficient and safe way to do that is, I think, very, very important," Jones told Reuters.
Belgium's Solvay and Shionogi and Co. Ltd. of Japan also stand to benefit if the combination is a winner. Abbott licensed rights to TriCor from Solvay and the two firms are also collaborating on next-generation fibrates, while Crestor was originally discovered by Shionogi scientists.
TriCor sales totalled $205 million in the first quarter of 2006. <<
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