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Abbott's FDC Simvastatin+Niaspan
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Abbott signs up Solvay as co-promotion partner for Simcor
22/10/2007
www.pharmatimes.com
Solvay has entered into a deal with old partner Abbott Laboratories which will see the Belgian firm get certain co-promotion rights in the USA to the lipid therapy Simcor.
Under the terms of the agreement, Solvay will provide sales support in the USA and contribute to development and promotional expenses. Financial details were not disclosed but Solvay will be "compensated based on product sales".
Simcor is a fixed-dose combination of the firm's Niaspan (extended-release niacin) and simvastatin, the active ingredient in Merck & Co's Zocor which came off-patent last year. The drug, which targets high-density lipoprotein or 'good' as well as low-density lipoprotein 'bad' cholesterol plus triglycerides in a single pill, was filed with the US Food and Drug Administration in April 2007.
The two companies said that the deal builds upon an ongoing agreement between Abbott and Solvay involving the commercialisation and development of its fenofibrate franchise, led by the old cholesterol-lowerer TriCor and ABT335/SLV34814, which is in Phase III.
Bifeprunox delay not the end of the world
Meantime, Solvay's chief executive Christian Jourquin has told a Belgian newspaper that the recent delay to getting marketing approval for the investigational antipsychotic drug bifeprunox is not a fatal blow to the firm's future plans.
Solvay and partner Wyeth received a non-approvable letter from the FDA in August after the agency concluded that "efficacy data, when compared to reference drugs, were not sufficient for approval". That decision, Mr Jourquin told Le Soir, "is a disappointment but a delay of two years does not put the group in danger".
The CEO added that the acquisition of France's Fournier a couple of years ago " allowed us to restructure our pharmaceutical activity in order to improve our financial results" and he claimed that expansion in countries such as Russia, Mexico and India would allow it to deal with pricing pressures in European countries.
Mr Jourquin concluded by saying that Solvay's priority remains the full integration of Fournier but stated that "if there are interesting acquisition projects, we will look at them".
Abbott files combination cholesterol drug Simcor with FDA
23/04/2007
Abbott Laboratories is looking to strengthen its position in the cholesterol medicine market and has filed its new combination drug Simcor with US regulators.
The firm has submitted a New Drug Application to the US Food and Drug Administration for Simcor, a fixed-dose combination of the firm's Niaspan (extended-release niacin) and simvastatin, the active ingredient in Merck & Co's Zocor which came off-patent last year. Abbott said that the product "seeks to target multiple lipid parameters in a single pill," noting that Niaspan is used to raise high-density lipoprotein or 'good' cholesterol levels, while simvastatin is effective in reducing low-density lipoprotein 'bad' cholesterol.
The combination is being submitted for FDA approval to address LDL, HDL and triglycerides, "which may lead to improved patient convenience and outcomes," said the company, and the Simcor application includes data from two large clinical studies, composed of more than 1,150 randomised patients, which evaluated safety and efficacy of the combination of Niaspan and simvastatin in patients with mixed dyslipidemia.
Eugene Sun, vice president of global clinical development at Abbott, said Simcor is "a promising next step in our efforts to develop therapies that support more comprehensive cholesterol management with one pill," adding that "combination lipid therapies are an increasing trend to help physicians reach their patients' treatment goals." According to the American Heart Association, more than 38 million Americans have complex lipid disease and combination therapy makes up around 15% of the more-than-$17 billion US cholesterol management market and represents the fastest-growing segment.
Simvastatin, in combination with Zetia (ezetimibe), is already sold by Merck and partner Schering-Plough as the blockbuster Vytorin, though the former firm announced at the end of 2006 that it was delaying the forecast filing date for MK-524B, which combines simvastatin with MK-524A, a novel compound that is currently in Phase III testing. This delay can only help the prospects of Simcor, which was developed by Kos Pharmaceuticals, the firm Abbott recently acquired for $3.7 billion, and Niaspan contributed $142 million to first-quarter sales.
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