Irvine drug maker Spectrum Pharmaceuticals Inc.’s bid to start selling its first brand-name cancer drug hit a snag late last week.
Food and Drug Administration reviewers raised several issues with an application for satraplatin, which fights advanced prostate cancer.
The FDA plans to ask an oncology advisory panel if action on the application should be halted until final patient survival data is in from a clinical trial.
The move stands to delay satraplatin’s ap-proval and was seen as a disappointment for Spectrum.
The news sent Spectrum’s shares down 30% on Friday. The company has a market value of about $120 million.
Investors also hammered Spectrum’s Ger-man development partner, GPC Biotech AG.
Regulators raised five issues, including whether one of the main goals in a study was acceptable for approval.
An outside oncology panel is set to review satraplatin, which also is known as Orplatna, this week.
Spectrum declined to comment on issues raised by regulators or a potential delay in approval. Satraplatin is a key part of the company’s bid to sell its own brand-name treatments for cancer.
Most of Spectrum’s revenue now comes from selling generic versions of common drugs.
A GPC spokeswoman declined to comment on the FDA summary but said, “We do remain convinced of the strength of satraplatin data.”
In earlier interviews, Spectrum officials were optimistic about satraplatin’s chances.
“This is really a culmination of (our) hard work of the last five years,” Chief Executive Rajesh Shrotriya said prior to the news.
As part of Spectrum’s strategy, the company is looking to acquire compounds that have potential for approval.
The company acquired satraplatin from London’s Johnson Matthey PLC in 2001. It began co-developing satraplatin with GPC in 2002.
A capsule, satraplatin is designed to treat patients whose prostate cancer doesn’t respond to standard chemotherapy or hormonal therapy that stops testosterone production.
Spectrum estimates there are roughly 45,000 to 50,000 late-stage prostate cancer patients whose condition could warrant satraplatin, said Russell Skibsted, the company’s senior vice president and chief business officer.
If approved, satraplatin also could be prescribed for men who’ve shied away from other treatments, perhaps because of side effects.
Half of chemotherapy candidates opt out of treatment, said Bela Denes, Spectrum’s senior director of clinical research.
Satraplatin contains platinum, an element found in intravenously administered chemotherapy drugs such as cisplatin, carboplatin and oxaliplatin.
Spectrum has some 10 drugs, according to Shrotriya.
They include ozarelix, a drug designed to treat benign enlarged prostate that’s in a mid-stage clinical trial. Spectrum received a license to develop and market ozarelix for North America and India from Aeterna Zentaris Inc. of Quebec City three years ago.
Spectrum, which had sales of about $6 million last year, gets revenue from several sources, including licensing and royalties.
The company has a lot riding on satraplatin. Approval would mean “cash (will) flow to the company on an ongoing basis,” Shrotriya said.
Spectrum is considered a development-stage company,it posted a net loss of $7.9 million on sales of $343,000 in the first quarter.
Shrotriya, whose career includes 18 years with Bristol-Myers Squibb Co., took over as Spectrum’s chief executive in 2002.
He’s overseen Spectrum’s transition away from neurology to cancer drugs, including a name change from NeoTherapeutics at the end of 2002.
Spectrum’s recent moves include a 2006 deal with Par Pharmaceutical Cos. of New York to sell and ship generic drugs. That deal calls for $10 million in milestone payments as well as profit sharing and a Par investment in Spectrum.
