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New Weight Loss/Diabetes/Lipids Drug
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"....Acomplia dramatically cut overall weight and, importantly, waist circumference. It also had a beneficial effect on HbA1c - a measure of blood glucose - triglycerides and HDL-c: in fact, the label granted by the European Commission states that an estimated 50% of the observed improvements in HbA1c, triglycerides and HDL-c were beyond that expected from weight loss alone...."
Sanofi-Aventis boosted by Acomplia data in type 2 diabetes
06/12/2006
www.pharmatimes.com
Sanofi-Aventis has presented data from a Phase III trial of its new obesity drug Acomplia (rimonabant) which shows that treatment-naive patients with type 2 diabetes who received the drug experienced significant improvements in blood glucose control and weight loss, compared to those who took placebo.
In the Serenade study, data for which was presented at the World Diabetes Congress in Cape Town, South Africa, 278 patients with type 2 diabetes who could not adequately control their disease with diet alone were randomised to receive placebo or Acomplia once daily for six months. Patients receiving the drug lowered their HbA1C (glycosylated haemoglobin - a measure of long-term glucose control) levels by 0.8% from a baseline value of 7.9, compared to a reduction of 0.3% for patients taking placebo.
Sanofi added that patients with a baseline HbA1C value of 8.5 or higher, and who received Acomplia, reduced their levels by 1.9%, compared to 0.7% in those who took placebo. The study also revealed that patients who received Sanofi's drug saw reductions in body weight of 6.7kg, compared to 2.7kg for patients in the placebo group. The Acomplia group also saw improvements in cardiometabolic risk factors such as a decrease in waist circumference, higher HDL or 'good' cholesterol levels, and lower triglyceride levels.
Glucose control independent of weight loss Sanofi estimated that 57% of the improvements in HbA1c levels were independent of the weight loss achieved, which could suggest that Acomplia has a direct impact on this measure of blood glucose control.
Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center and an investigator on the Serenade trial, said that "the management of type 2 diabetes should not only focus on controlling blood sugar levels, but also improve other risk factors such as weight, good and bad cholesterol, triglycerides and blood pressure. This study suggests that rimonabant can achieve improvement in blood glucose with the added benefit of significant weight loss and improvement in other risk factors."
The results from the trial suggest that Acomplia's positive effect on cardiometabolic risk factors come from the product itself and not just from weight loss, which could prove crucial in the thorny issue of reimbursement.
Sanofi shares rose as investors greeted the data with enthusiasm, and the study "helps them to say, 'this is a proper drug, not just an anti-obesity drug'," according to Nomura Code analyst Paul Diggle, who added that Acomplia did cut blood sugar levels by more than he had estimated, but that its side effects - dizziness, nausea, anxiety, depressed mood and headache - were worse than expected.
Acomplia is a key product for Sanofi, especially as a number of its major drugs are facing pressure from generics, notably the antithrombotic Plavix (clopidogrel), Allegra (fexofenadine) for allergies, Amaryl (glimepiride) for diabetes and its oncology agents Eloxatin (oxaliplatin) and Taxotere (docetaxel). Depending on its indications, some observers believe Acomplia could be worth up to $3 billion a year to the firm at its peak.
Sanofi-Aventis cheered as Acomplia cleared in Europe
22/06/2006
Broad smiles all round for Sanofi-Aventis yesterday after a potential star in its pipeline, Acomplia (rimonabant), was cleared for marketing by the European Commission for use alongside diet and exercise in treating overweight and obese patients who are showing signs of dyslipidaemia and other risk factors associated with the condition.
Sanofi-Aventis is targeting patients with so-called cardiometabolic risk factors - including high LDL cholesterol and hypertension - that predispose an obese patient to develop type 2 diabetes or cardiovascular problems. Of growing importance, it says, is the role of abdominal obesity - so-called the 'apple' versus 'pear' shape - which has a particular association with the emergence of insulin resistance, low levels of the 'good' HDL-cholesterol, high triglyceride levels and raised inflammatory mediators such as C-reactive protein.
A recent meeting heard from Julian Halcox, a senior lecturer in cardiology at the British Heart Foundation, about the growing recognition of abdominal obesity's role in the development of macro- and microvascular complications. "Visceral fat [that contained within the abdominal cavity] is an active endocrine organ that promotes insulin resistance, for example, by stopping the liver metabolising glucose," he explained. Visceral fat is also linked to raised inflammatory markers such as interleukin-6 and tumour necrosis factor-alfa, as well as reduced levels of the insulin promoter adiponectin. "If you can reduce body weight by 10%, your total cholesterol level will be reduced 10%, your LDL-c by 15% and your fasting glucose by 50%. In addition, your 'good' HDL-c will be boosted 8% and - most significantly - you will lose approximately 30% of your visceral fat. The abdomen is one of the first places fat is mobilised from, which is why it causes problems in the first place," he finished.
The approval was based on data from a 6,600-patient study dubbed RIO, which found Acomplia dramatically cut overall weight and, importantly, waist circumference. It also had a beneficial effect on HbA1c - a measure of blood glucose - triglycerides and HDL-c: in fact, the label granted by the European Commission states that an estimated 50% of the observed improvements in HbA1c, triglycerides and HDL-c were beyond that expected from weight loss alone.
A first-in-class offering, Acomplia works by selectively blocking CB1 receptors found in the brain and other organs that play an important role in glucose and fat metabolism. However, it has not been all plain sailing en route to market. Earlier this year it was forced to put back the anticipated launch date for Acomplia after being sent an approvable letter for the drug by the US Food and Drug Administration. Sanofi-Aventis had originally scheduled a launch in the first half of this year, but is still clearly hoping to win a nod during the second half.
Despite this, Acomplia is widely tipped to become a future blockbuster and represents a key player in the Sanofi's growth strategy. It is hoped that the drug will help the company to overcome generic erosion of sales of some of its key players, including the antihistamine Allegra (fexofenadine), the diabetes drug Amaryl (glimepiride), Arava (leflunomide) for arthritis and DDAVP (desmopressin). In fact, a recent report from Decision Resources revealed that the metabolic syndrome market looks set to nearly double over the next few years, leaping from $9.5 billion in 2004 to just shy of $18 billion in 2014. Analysts are predicting the market will be driven by Acomplia, with revenues in excess of $3 billion a year forecast.
Acomplia will first be launched in the UK - which has seen a 70% jump in obesity over the last decade and is following 12 years behind the USA - in July, and will be closely followed by Denmark, Ireland, Germany, Finland and Norway later during the second half of the year.
Metabolic syndromes market to rocket
02/03/2006
The metabolic syndrome market looks set to nearly double over the next few years, leaping from $9.5 billion in 2004 to just shy of $18 billion in 2014, according to a report by market research analysts Decision Resources.
The new Pharmacor report - Metabolic Syndrome - says that market growth will be led by Anglo-Swedsish drugmaker Sanofi-Aventis' Acomplia (rimonabant) and US drug giant Pfizer's fixed-dose Lipitor (atorvastatin) and torcetrapib combination. In 2014, Acomplia and the Pfizer's combo will pull in over $3 billion in sales, collectively swallowing 17% of the total market to treat metabolic syndrome.
People with the metabolic syndrome are at increased risk of coronary heart disease and other diseases such as stroke and type 2 diabetes. The battle for new, effective therapies to treat metabolic syndrome, a condition characterized by a group of metabolic risk factors in one person such as obesity, high blood pressure, insulin resistance/intolerance and blood fat disorders, is hotting up, but both of these products are yet to make it to market.
Sanofi-Aventis has recently pushed back the expected launch date for Acomplia to the second half of the year, after receiving an approvable letter for from the US Food and Drug Administration. Crucially, the group has confirmed that the FDA has not asked for an additional clinical trial to support approval of Acomplia in obesity, but another will be needed to support its approval in smoking cessation, an indication rejected by the agency outright.
Meanwhile, the future of Pfizer's offering is also unclear. Reports recently emerged that the combination could face another two to three years of clinical trials, and the company is still undecided as whether to offer torcetrapib as a standalone therapy as well as in combination with Lipitor, after doctors voiced concerns over being pushed into choosing the Lipitor combo over rival cholesterol-lowering compounds, including Merck & Co's Zocor (simvastatin).
Pfizer is investing some $800 million in the Phase III programme for Lipitor/torcetrapib as part of its bid to reach the market ahead of rivals also battling to develop a drug with a dual action on both low-density and high-density lipoprotein cholesterol, and investors will be banking on Pfizer getting its product approved before Lipitor - an $11 billion drug - loses its patent protection in 2011.
The DR report also highlights the urgent need for a common definition of metabolic syndrome. "While we expect this market to grow substantially over the next decade, the achievement of a consensus definition of metabolic syndrome will have broad implications for the future of the market," remarked DR analyst Donny Wong. "As the medical community continues to debate the different criteria that define metabolic syndrome, the recent release of similar definitions from the International Diabetes Federation and the American Heart Association marks a key milestone in the growing consensus among physicians."
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