Alkermes to file first 'homegrown' product
development as it gears up to file for marketing approval of its
own product, rather than applying its technologies to drugs sold by
customers.
If successful, the move will reduce Alkermes' reliance on the performance of its customers and allow it to book profit on end-product sales, rather than receive a royalty rate. In the third quarter Alkermes reported a net loss of $9 million (€7m), less than half the $21m loss reported a year ago, but believes approval of its Vivitrex (naltrexone) product for treating alcohol dependence is the key to its long-term growth.
Driving the company at present is the manufacturing and royalty revenue it receives from Johnson & Johnson on sales of Risperdal Consta (risperidone), a drug to treat schizophrenia based on Alkermes' Medisorb technology. This allows it to be administered by injection once every two weeks, rather than each day as is required with the older tablet form of the drug.
Risperdal Consta is thought to be the main driver behind the 29 per cent hike in revenues for the Risperdal franchise in the fourth quarter of 2004, with sales reaching $846 million, and is expected to rise in importance as the oral form of the drug loses patent protection in 2006.
Over the same period (its third quarter), Alkermes booked $16.6 million from manufacturing and royalty payments relating to the J&J drug, a rise of 67 per cent on the third quarter. Meanwhile, total turnover at the company was $23.6 million, more than double the $11.2 million recorded a year earlier, helped by a hike in R&D revenues from partners Eli Lilly and Amylin.
For Alkermes' management, the increased margins afforded by an in-house product must be considerable. Vivitrex is due to be filed in the US in the first half of this year and, while it does not address a huge market, has properties that could improve patient compliance with therapy and so make it the drug of choice. It requires dosing just once a month, while current formulations of the drug must be given each day.
Alcohol is a major killer in today's society, with 3 to 4 per cent of the population in Europe alone heavily addicted, and a further 6 to 9 per cent at risk from dependence through excessive drinking. The indirect and direct health care costs that surround this addiction are enormous, with estimates ranging from $70bn to $120bn in the US alone.
At present the US market for drug-based alcoholism treatment is dominated by two treatments, disulfiram and naltrexone, but these are elderly, not very effective and carry a significant risk of side effects. A newly-launched drug, Forest Laboratories' Campral (acamprosate), seems to offer better results but still requires patients to take two tablets three times a day, which could be a barrier to patients completing their therapy. Vivitrex could be of particular use in people with severe alcoholism, who have the greatest difficulty sticking to treatment, according to Alkermes.
