Winning US FDA approval for omega-3 API suppliers like BASF and Chemport is a key milestone for Amarin in 2013 according to CEO Joe Zakrzewski.
Zakrzewski told investors at the J.P. Morgan Healthcare Conference that Vascepa started shipping last week ahead of the planned launch at the end of the month, citing the firm’s API suppliers as critical to the process.
“We’ve established exclusive relationships with leading omega-3 supplies. We have four API suppliers and two encapsulators” he said, adding that “We’ve filed the sNDA for a number of additional suppliers and we are looking for that approval.”
Amarin filed a request with the FDA seeking approval for BASF on January 2, six months after the German chemicals giant bought former supplier Equateq and just weeks after the Irish drugmaker submitted a similar sNDA for South Korea-based manufacturer Chemport.
Omega-3 deal slipping away?
The comments, coupled with Zakrzewski announcement that Amarin has started shipping Vascepa ahead of a planned launch this month, are a welcome positive for BASF’s omega-3 team whose efforts to acquire a second supplier – Norway’s Pronova Biopharma – encountered some resistance this week.
To recap, BASF made a $671m bid for Pronova in November , announcing that it had already secured irrevocable acceptance from investors holding 59.4 per cent of the Norwegian firm’s shares and predicting that the deal would be done by December 19.
However, BASF had only won approval from investors holding another 8 per cent of shares by the December deadline, which was short of its 90 per cent target. In response , the German firm extended its deadline to January 18.
Since then a number of Pronova shareholders have voiced their opposition to the deal. According to a Bloomberg report investors and funds holding a combined 20 per cent stake in the omega-3 maker wanting BASF to improve its offer.
The German firm declined to comment when contacted by in-Pharmatechnologist.com.