Forest's lercanidipine approvable, says FDA

Lercanidipine, a new calcium antagonist originated by Italy's Recordatiand licensed to Forest Laboratories in the USA, has been deemed approvable by that country's Food and Drug Administration. The agency has asked for some additional documentation on the drug, but Forest has indicated that it should be able to address this within the next few months, putting the product on track for a US launch in the second half of 2003. Lercanidipine is already on the market in 36 countries and approved in 58, noted Recordati in a statement.

This launch schedule is delayed somewhat from the company's earlier aspirations, and as a result Forest's share price dipped 4% to $69.14 on the news. The company is perceived as needing to build up some new products as it faces patent expirations on its biggest seller, the antidepressant Celexa (citalopram), in 2004 (Marketletters passim). Lercanidipine is seen as a key drug for Forest as it targets the extremely large market for antihypertensive drugs, in which calcium antagonists are currently showing strong growth. Analysts have tipped the new drug to achieve US sales in excess of around $500 million a year at its peak.

Lercanidipine's importance to Forest was further enhanced recently after the regulatory authorities in Denmark suggested that the firm's single-isomer follow-up to Celexa, Lexapro (escitalopram), had no significant advantages over its predecessor. Forest licenses both these drugs from Danish pharmaceuticals company H Lundbeck, which already sells escitalopram in Denmark under the Cipralex trade name.