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The joint venturers’ production facilities in North Carolina and Denmark have already been inspected by the relevant authorities in America and Europe and “there have been no issues”, Elan said last week.
The sales staff recruited recently will augment the marketing effort to hospitals that has been continuing. A key worry for analysts is that earnings from the drug may not materialise as quickly as hoped for in financial circles because the relevant neurologists may not be primed to use it.
The sales effort is concentrating on neurologists in the main hospitals in bigger cities across Europe and America. This distribution would be well in hand to meet the deadline, Elan said.
The US Food and Drugs Administration (FDA) has put Antegren on the so-called fast-track mode because it is meeting a need that has not yet been addressed. One broker said the closer the product comes to the deadline without objection, the less likely the FDA is to raise any issues.
The performance of the drug will determine Elan’s future prospects. The company raised debt of $850m (€665m) last week in a mixture of fixed- and floating-rate notes to help pay back outstanding loans and fund Antegren’s launch and continued research into other diseases, particularly Parkinson’s and Alzheimer’s.
“It also gives weight to the stated intention of acquiring further pipelines at the later stage of their development,” said Ian Hunter, an analyst with Goodbody Stockbrokers.
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