September 19, 2016
By Alex Keown, BioSpace.com Breaking News Staff
HENDERSON, Nev. -- Nearly one-week after a U.S. Food and Drug Administration advisory committee rejected Spectrum Pharmaceutical ’s bladder cancer drug qapzola (apaziquone), a report has surfaced that the company allegedly concealed from its investors that FDA officials told the company not to seek approval of the drug.
The regulators said the drug failed to show benefits to patients during two clinical trials. The Street’s Adam Feuerstein reported Friday that Spectrum was told by regulators not to seek submission in 2012. That means that for at least three years, the company concealed information about the drug’s lack of a chance of approval. In fact, last year, Feuerstein reported that Rajesh Shrotriya, chief executive officer of Spectrum Pharmaceuticals, told an analyst during a conference call that the company had met with the FDA and was told it could file a New Drug Application, despite the two failed trials.
“So we took that data, met with the FDA,” Shrotriya said in response to the analyst’s question, according to Feuerstein’s report. “And our understanding is and our decision is that we can go ahead and file the NDA with this drug, but FDA wanted us to start another trial, take all the learnings from the first two trials and incorporate them into the new protocol.”
However, when the drug was rejected by the advisory panel, the FDA’s original urging to not seek approval was revealed.
In its rejection, the FDA panel said the drug “has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer.” While the panel’s ruling is only advisory, it is unlikely the drug would receive approval when the drug goes before the FDA in December.
Why is Spectrum’s failure to disclose the information important?
Well, certainly investors do not want to be misled by any company regarding future revenue streams. Also, last year, The Street noted that the FDA issued a report that drug companies “routinely fail to fully inform the public about their communications with the agency.” In its analysis, the FDA said that the companies provide information to investors that are either misleading or lies, according to The Street.
Other companies that have been criticized for lack of transparency include Amgen , Clovis Oncology , Introgen Therapeutics and Sarepta Therapeutics , the Street said.
Additionally, Feuerstein said the U.S. Securities and Exchange Commission has urged pharmaceutical companies to be more transparent about their dealings with the FDA.
Shares of Spectrum are trading at $4.89 this morning, still down from its pre-FDA rejection price last week of $5.69. The stock had a year high of $7.65 per share in April.
