SimcorTreatment for Hyperlipidemia
Update: Simcor Now FDA Approved - February 15, 2008
Abbott and Solvay Pharmaceuticals to co-promote Abbott's Simcor in the United States
BRUSSELS, Oct. 22, 2007-Solvay Pharmaceuticals has entered into an agreement granting Solvay select co-promotion rights in the United States for Abbott's investigational fixed-dose combination lipid therapy, Simcor (Niaspan/simvastatin), currently awaiting U.S. Food and Drug Administration (FDA) approval.
Under the terms of the agreement, Solvay will provide sales support in the United States, contribute to development and promotional expenses and be compensated based on product sales. Specific financial terms were not disclosed.
Simcor combines two well-established and leading medications, Niaspan and simvastatin, to target multiple lipid parameters - LDL "bad" cholesterol, HDL, "good" cholesterol and triglycerides – in a single pill. Abbott submitted its New Drug Application to the FDA for Simcor in April 2007.
Simcor builds upon an ongoing agreement between Abbott and Solvay Pharmaceuticals involving the commercialization and development of fenofibrate, and continues both companies' commitment toward the treatment of lipid disorders.
Available since 1997, Niaspan is the only available FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate, to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hyper-cholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction or in patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important Safety Information About Niaspan
Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash.
Important Safety Information About Simvastatin
Simvastatin is a prescription tablet and isn't right for everyone, including women who are nursing or pregnant or who may become pregnant, and anyone with liver problems. Unexplained muscle pain or weakness could be a sign of rhabdomyolysis, a rare but serious side effect and should be reported to a doctor right away. Simvastatin may interact with certain foods or other medicines including lipid-lowering medications called fibrates or niacin, increasing a patient’s risk of getting this serious side effect. Patients should tell their doctor about any other medications they are taking. The most common side effects are headache, abdominal pain, and constipation.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2006 sales were EUR 2.6 billion, and it employs approximately 10,000 people worldwide.
solvay is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 29,000 people in 50 countries. In 2006, its consolidated sales amounted to EUR 9.4 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com
Posted: October 2007
- Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths - July 29, 2010
- Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management - February 19, 2008
- Abbott Submits New Drug Application for Simcor Combination Niaspan/Simvastatin Tablet - April 20, 2007