It just goes from bad to worse for Glaxo.
On October 18 I saw a news item – Gepirone ER branded Velexity® It seemed that McCann Humancare in New York had landed creative duties on the launch of a new antidepressant from GlaxoSmithKline known as Velexity. It was going to be BIG with billings estimated at more than $40 million.
However, today I have found out that geprirone ER has been rejected AGAIN by the FDA. This from the Washington Post:
U.S. regulators have rejected GlaxoSmithKline Plc’s (GSK.L) experimental drug gepirone ER for adults with major depression.
The U.S. Food and Drug Administration (FDA) issued a not approvable letter for the extended-release tablets, which Glaxo had licensed from privately owned Fabre-Kramer Pharmaceuticals Inc in February, Europe’s biggest drugmaker said on Saturday.
The news is a blow to Glaxo, which needs new drugs to make up for pending patent expiries on key blockbusters and a recent slump in sales of its second-biggest seller, the diabetes pill Avandia, which has been hit by fears over a possible link to heart attacks.
Industry analysts had forecast that gepirone ER, if successful, could eventually have sold between $800 million and $1.6 billion a year. But the product was always viewed as high risk, following a chequered history in development.
Akzo Nobel NV (AKZO.AS) of the Netherlands had originally been developing gepirone ER with Fabre-Kramer but the Houston-based drug company bought back rights to the drug in June 2005 after Akzo abandoned development in the wake of two earlier rebuffs from the FDA.
Despite these setbacks, Glaxo had hoped that gepirone ER might still be approved if it provided data from an additional positive clinical trial. Those extra results were submitted to in May 2007 but, in event, proved insufficient to sway the U.S. regulator.
Glaxo and Fabre-Kramer said they were now evaluating the response from the FDA to determine appropriate next steps.
The financial terms of February’s deal between Glaxo and Fabre-Kramer were never disclosed but Moncef Slaoui, Glaxo’s head of research and development, said at the time that gepirone ER was an important addition to the company’s late-stage pipeline.
The clinical trail mentioned in the article was by none other than Dr Marty Keller (and he doesn’t come cheap). Keller’s results found “In conclusion, gepirone ER at a dose range of 40 to 80 mg/d is effective for relapse prevention in patients with recurrent major depression. It is well tolerated during long-term treatment for up to approximately one year.”
I’m sure that many of you will know Marty Keller and the work he has done for GSK in the past… those of you who don’t know how Glaxo use data from their clinical trials see Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug and And while we’re talking about Study 329 – here are some real Seroxat Secrets and gepirone ER – enter Marty Keller
Marty Keller? – top professsional and honest as the day is long…