Johnson & Johnson subsidiary Janssen-Cilag International has filed for approval to market a new once-daily drug for schizophrenia, paliperidone, with the European Medicines Agency.
Paliperidone uses a drug delivery technology developed by Alza, another J&J subsidiary, called OROS, which releases drug into the bloodstream steadily over a 24-hour period. J&J asked the US Food and Drug Administration (FDA) to approve the new drug last November.
The delivery technology is designed to avoid the peaks and troughs of drug levels in the blood that occur with other antipsychotics and, hopefully, lead to improved control of symptoms, although J&J has not yet reported any clinical data to illustrate this.
J&J already has a successful schizophrenia franchise with Risperdal (risperidone), but this product is jostling for market share in an increasingly crowded segment with drugs such as Eli Lilly's top-selling Zyprexa (olanzapine), AstraZeneca’s Seroquel (quetiapine) Pfizer's Geodon (ziprasidone) and Bristol-Myers Squibb's Abilify (aripiprazole).
Sales of Risperdal climbed 21% to $1.01 billion in the first quarter of this year, having brought in $3.6 billion in 2005 as a whole. But the product could face generic competition as early as next year in the important US market, and paliperidone would help J&J support its schizophrenia franchise in the event of a tail-off in sales of its older brand.
Plans for reorganising pharma R&D?
Meanwhile J&J reportedly told its employees late last week of plans to divide its pharmaceuticals group into three major disease or therapeutic clusters, each with its own research and development focus, according to a report in the New York Times.
The three clusters will be: central nervous system, pain, infectious disease, metabolism, cardiovascular and primary care; immunology, cancer and biotechnology; and virology.
The company said the reorganisation was intended to create ''greater synergy'' between its research activities and their commercial possibilities, and comes shortly after J&J reported a 2.2% decline in pharmaceutical sales in the first quarter of 2006, as a result of generic competition to its painkillers Duragesic (fentanyl) and Ultracet (tramadol) and the antifungal Sporanox (itraconazole).