Generic drug maker Spectrum Pharm-aceuticals Inc. is set to start selling its first brand-name drug this month.
Irvine-based Spectrum plans to introduce Fusilev, a chemotherapy injection for osteogenic sarcoma,a rare form of bone cancer,on Aug. 15, Chief Executive Rajesh Shrotriya said.
Fusilev, also known as levoleucovorin, is what’s called an “adjunct” drug. Doctors prescribe it to enhance the effectiveness and reduce the toxicity of other drugs to treat osteogenic sarcoma, a cancer that usually affects children.
The Food and Drug Administration approv-ed Fusilev in June.
Spectrum has the U.S. rights to sell Fusilev. The drug already is sold in Europe and Japan by other drug makers, including Takeda Pharmaceutical Co., Wyeth and Sanofi-Aventis.
Fusilev has yearly sales of some $200 million, according to Shrotriya.
Spectrum, which has shifted its focus from generic to brand-name drugs in recent years, plans to market Fusilev on its own.
“We will be taking the drug literally from the test tubes to our patients,” Shrotriya said.
Spectrum has hired a vice president of marketing and sales, an executive director of sales and several regional business directors with experience selling cancer drugs.
“The initial sales of this drug will be small,we are not building a 100-person sales force,” Shrotriya said.
The market for Fusilev also is relatively small. About 3,000 patients are diagnosed with osteogenic sarcoma yearly in the U.S.
Spectrum plans to seek regulatory approval for Fusilev for treating colorectal cancer, a much larger market, Shrotriya said. Some 150,000 people are diagnosed with colorectal cancer each year in the U.S.
Having a “small reasonable sales force is just fine” for Fusilev, said Ren Benjamin, an analyst with Rodman & Renshaw Capital Group Inc., a New York-based investment bank.
If Spectrum is cleared to market Fusilev for colorectal cancer, “they will need the marketing muscle of a partner,” Benjamin said.
Spectrum had sales of $7.6 million last year and a recent market value of about $45 million.
The company had $69 million in cash as of the first quarter. It got an infusion in May, when it received $20 million from Par Pharmaceutical Cos. of Woodcliff Lake, N.J., for a stake in a generic version of GlaxoSmithKline PLC’s Imitrex.
Spectrum said at the time it would use the money to help launch Fusilev. The company got the rights to Fusilev in 2006 from Targent Inc., a New Jersey drug maker.
Setbacks
Spectrum has seen setbacks in its bid to sell branded drugs, including an attempt last summer to sell satraplatin, a pill to fight advanced prostate cancer.
FDA reviewers raised several issues over satraplatin with GPC Biotech AG, a German company that worked with Spectrum on the drug.
“We were just as surprised as the media was and the investors were,” Shrotriya said. “It seemed like there was some sort of misunderstanding with our German partner.”
GPC pulled satraplatin’s U.S. application last year after the FDA indicated it wouldn’t approve it. The company said late last month that a European regulatory application was withdrawn and that it was working on its next step regarding the drug’s development.
Shrotriya said he wasn’t worried about any backlash from the experience.
“The FDA is very objective,” he said. “If you can demonstrate the data are safe and effective, you walk through it.”
Wall Street continues to be lukewarm on Spectrum. The company’s shares are down some 45% this year. Some observers blame the drop on disappointing clinical trial results for ozarelix, Spectrum’s drug candidate to treat an enlarged prostate gland.
The company said in April that ozarelix didn’t reach expectations because of clinical trial issues.
“It is always possible that a new drug (launch) could regenerate shareholder value,” analyst Benjamin said, referring to Fusilev. “If sales of the drug are better than anticipated, it could be reflected in the stock price.”
Spectrum’s pipeline also includes EOquin, a bladder cancer drug in late-stage clinical trials.
Shrotriya said he contends healthcare and biotechnology sectors are out of favor with Wall Street because investors “are running to make quick bucks on oil.”
“The way I look at it, it is a short-term phenomenon,diseases are here to stay as long as there are human beings,” he said.
