BMS schizophrenia drug wins US approval
pharmafile | October 22, 2003 | News story | |
New atypical antipsychotic Abilify has gained FDA approval for the treatment of schizophrenia and is tipped to eventually become a blockbuster for manufacturers Bristol-Myers Squibb.
The drug, which either blocks or stimulates dopamine and serotonin receptors as needed, is the first of its kind to be launched in the US, although Sanofi-Synthlabo has launched a similar drug, Solian, in Europe.
Trials of the drug have shown patients have not gained weight, a common side-effect in other drugs in the class, and the company hopes this and the lack of other side-effects will allow Abilify gain a foothold in the crowded $7 billion antipsychotic market.
Nick Alcock, Senior CNS Analyst at Datamonitor, said: "It unlikely to become a blockbuster in the immediate term but maybe it could over a 10-year period. It will definitely be more than a $500 million product".
The approval is particularly welcome for the company, which has been experiencing problems with a number of product launches.
Early this year cardiovascular treatment Vanlev, another potential blockbuster, proved disappointing in clinical trials. The company has also battled throughout 2002 with the fallout from its involvement in ImClone cancer drug Erbitux.
The FDA's rejection of the drug clinical trial data resulted in a congressional investigation into the product, and great uncertainty about whether it will ever reach the market.
Peter Dolan, Chairman and Chief Executive of BMS, said: "For Bristol-Myers Squibb, [Abilify] marks the beginning of a new generation of innovative medicines for the benefit of patients everywhere".
Meanwhile, sales of the company's older drugs like Glucophage, Taxol and BuSpar are now suffering from generic competition.
BMS has experience of operating in psychiatry and, to a lesser degree, depression, but it will be competing with established companies in the schizophrenia market.
Johnson & Johnson's Risperdal currently leads the atypical market, with sales of $1.8 billion in 2001, with Eli Lilly's Zyprexa and Pfizer Geodon in pursuit. In particular, Lilly is aggressively increasing its US marketing support for Zyprexa.
"Lilly is the benchmark company in terms of marketing in the psychiatric arena, especially in the US", Nick Alcock said.
Psychiatry is a smaller market than depression and Lilly has been repositioning Zyprexa away from schizophrenia towards conditions such as bipolar disorder, he added. If BMS can move the drug into new markets then it will have a better chance of achieving its blockbuster potential.
Abilify is currently under review for European approval, and will be co-marketed with Otsuka America Pharmaceutical in the US.
