THE Athlone-based pharmaceutical company, Elan, has received approval from the US Food and Drug Administration (FDA) for a new arthritis drug which is expected to gross up to $100 million (£63 million) a year in the US. Significantly, the approval also marks the end of an FDA review of Elan's management practices.
Elan, which is Ireland's fifth-largest company, saw its share price fall from $43 to $39 1/4 when news of the review was announced last July. The company's New York share price closed last night at $50 5/8, largely in anticipation of FDA approval for the arthritis drug, Naprelan.
According to American Home Products Corporation, which is the company licensed to sell Naprelan in the US, the drug is expected to have sales of between $50 million and $100 million in the US in its first year. Elan will receive about 25 per cent of this.
Naprelan is one of a group of non-steroidal anti-inflammatory drugs (NSAIDs) used in the treatment of arthritis. At present about 25 per cent of the $1.6 billion NSAID market in the US is held by a drug called Naproxen. A spokesman for Elan said the company expected Naprelan to take a significant share of the Naproxen market before going on to challenge other NSAIDs.
Naprelan, he said, is the first product approved by the FDA using "intestinal-protection drug-absorption treatment". This means that it reduces the risk of stomach upset.
The approval of Naprelan marks another important mile-stone, the company's president and chief executive officer, Mr Donal Geaney, said in a statement yesterday.
Elan expects to launch Naprelan before the end of March. The company is seeking approval for the drug in countries other than the US. Elan expects Naprelan to receive approval for use in the European Union within the next 12 months.
Yesterday's approval marked the end of an FDA review which related to Elan's principal product, the hypertension drug Cardizem. Cardizem grosses about $800 million a year, of which Elan receives between 3 per cent and 5 per cent.
The review delayed the approval of Naprelan for about two months. Ironically, however, that delay may have benefited the company. Elan will enjoy a three-year period of exclusivity for Naprelan. As the launch date for the drug has not been affected, the company will now benefit from that exclusivity for two months more than it would have had the approval not been delayed.
