Friday 19th May 2017
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AFT Pharmaceuticals obtained regulatory approval to sell its Maxigesic painkiller in nine additional European countries, a move that lets it ramp up international sales of its tablets.
The Auckland-based drug maker said the European Medicines Agency approved Maxigesic tablets in Austria, Belgium, Croatia, France, Germany, Luxembourg, Netherlands, Portugal and Spain. These countries have been added to the existing European countries where Maxigesic has been approved for sale.
"Collectively they have over US$1.8 billion of annual sales of paracetamol and ibuprofen tablets,” said chief executive Hartley Atkinson. "So approval across most of the EU is a crucial piece of the puzzle for Maxigesic in terms of ramping up international sales and significantly reducing the regulatory risk for Maxigesic tablets."
The EMA’s decision immediately clears the way for Maxigesic product launches in countries where AFT Pharmaceuticals already has a license agreement in place: Belgium, Luxembourg, Spain, Portugal and Ireland. It will add to existing launches in the UK, Italy and a planned launch in the Nordics. The EMA decision is expected to accelerate licensing negotiations in EU countries where agreements are not yet in place.
"We know that for most of the EU, Maxigesic has now been approved, and so we expect to make further progress in reaching licensing agreements in those remaining EU countries in this financial year," said Atkinson.
Earlier this month, AFT said it sold 74 million tablets in the year ended March 31, up from 22 million tablets a year earlier, it said in a statement. The company will report earnings next Wednesday and in March said it expected to generate annual sales of between $69 million and $71 million, up from $65.8 million a year earlier.
The stock last traded at $2.30 and has fallen 25 percent over the past 12 months.
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