Indevus and Two-Year Delay on NEBIDO (IDEV)
Indevus Pharmaceuticals Inc. (NASDAQ: IDEV) is seeing shares taken behind the building to face the firing squad. The company expects the FDA to formally request that it provide additional safety data prior to approving NEBIDO. It believes that an additional study will be required in order to supply the necessary data.
The company now expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review, so this process is going to be pushed back by two years according to its data. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the co expects to receive by the original June 27, 2008 PDUFA date.
This may relate to a reaction immediately following the injection, which it says is a known rare complication of oil-based depot injections. The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and it may even be due to improper injection technique.
The company also believes that the FDA’s safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml) dose.
Shares were halted earlier, but now that the market has opened it isn’t looking good at all. Indevus shares are down 66% at $1.37, and its prior 52-week trading range was $3.91 to $8.22. With a now much lower market cap of $107 million, its balance sheet looks inverted because of a $142 million deferred long-term liability charge on the books. It had $60.765 million cash on the books at the end of last quarter.
With this delay of two-years and with its other ongoing trials and candidate programs, this company may need to seek cash.
Jon Ogg
June 4, 2008
