Spectrum’s Fusilev Faces No Generic Threat, Shrotriya Says

Spectrum Pharmaceuticals Inc.’s colon-cancer drug Fusilev won’t face generic competition until the shot’s patent protection expires in eight years, Chief Executive Officer Rajesh Shrotriya said.

Spectrum declined 5.1 percent to $13.83 at the close in New York, the biggest single-day drop in a month. Earlier today, the Food and Drug Administration said an undisclosed rival applied to sell a copy of Fusilev, the Irvine, California-based company’s top-selling product.

While generic-drug makers often challenge patents years before they expire “so they can be ahead in line,” Spectrum’s patent protection for Fusilev is “rock solid and it is good through Dec. 31, 2019,” Shrotriya said today in an interview.

Fusilev accounted for 43 percent of Spectrum’s sales last year, earning $32 million. Revenue from the drug may more than triple to $112 million this year, according to the average estimate of two analysts surveyed by Bloomberg. The drug, an injection known chemically as levoleucovorin, first won FDA approval in 2008 for patients with a bone tumor called osteosarcoma.

Fusilev has an additional layer of protection from generic competition through 2018 under the FDA’s “orphan drug” program because it treats patients with the rare bone cancer, Shrotriya said. The program grants marketing exclusivity to drugs for illnesses that affect fewer than 200,000 people in the U.S.

Wider Use Approved

The agency also cleared the drug for wider use in April for patients with advanced colon cancer. The FDA had earlier taken steps to make Fusilev available to colon-cancer patients amid a shortage of leucovorin, a generic drug that had been the standard treatment.

“Fusilev sales should continue to benefit through 2012 from supply disruptions of leucovorin,” Jason Kantor, an analyst at RBC Capital Markets in San Francisco, said today in a note to clients.

Fusilev is a purer compound than leucovorin, so it’s effective at half the dosage, according to Spectrum’s Fusilev website.

“We have made ample supplies available,” Shrotriya said. “We want to make sure colorectal cancer patients do not go without treatment. That has been their problem and challenge during the shortage.”

A generic-drug maker submitted an application on Oct. 26 to sell a copy of Fusilev, the FDA said today on its website, without disclosing the company’s identity.

When a generic-drug maker files such an application, the company is certifying that its product doesn’t infringe any valid patents. The maker of the brand-name treatment then has a set period of time to sue to block the FDA approval process from proceeding for 30 months or until the litigation is completed, whichever comes first.

Generic-drug makers who are the first to file such patent challenges are later entitled to market their copies, once approved, for six months without competition from other copycat versions.

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