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Dendreon Says Provenge Now OK on Reimbursements

A top executive of Seattle-based biotech Dendreon Corp., which has a manufacturing plant in Seal Beach, recently visited Orange County to update investors.

Dendreon makes Provenge, a treatment for advanced prostate cancer that’s made from a patient’s own white blood cells. The drug is intended for cancers that are resistant to traditional chemotherapy.

Dendreon Chief Financial Officer Greg Schiffman spoke last month at the annual investment conference hosted by Newport Beach-based Roth Capital Partners LLP at the Ritz-Carlton in Dana Point.

Joseph Pantginis, Roth’s drug industry analyst, hosted Schiffman’s talk.

Schiffman gave an insurance reimbursement update, along with new details on Dendreon’s efforts to make cancer patients aware of Provenge’s availability.

“Reimbursement really was a key item or a challenge for the company,” Schiffman said.

The drug maker’s shares plummeted 67% in mid-2011 after company officials acknowledged acceptance and use of the drug, which costs $93,000 per treatment, would likely come more gradually than first believed.

The challenges on reimbursement are now behind Dendreon, according to Schiffman.

“We believe at this point you’ve got the vast majority of all private-pay [insurers] and certainly Medicare reimbursing the product,” he said.

Dendreon now is focusing on broadening its customer base among cancer and urology doctors, Schiffman said.

One tactic: an advertising campaign for Provenge that started last month.

“From a consumer standpoint, all the research is indicating a strong need to educate the consumer, and we’ve got the [direct-to-consumer] television advertising that actually has kicked,” Schiffman said.

Dendreon plans to spend a “very efficient $5 million per quarter” on advertising, something Schiffman said “gets you very broad-based coverage.”

Schiffman also touched on Dendreon’s manufacturing and said the company plans to introduce more automation to its plants in 2014.

Dendreon trimmed its manufacturing operations in recent months but retained its plants in Seal Beach and the Atlanta suburb of Union City, Ga. The company sold a plant in Morris Plains, N.J., to Novartis Pharmaceuticals Corp., a unit of Novartis AG in Switzerland, for $43 million late last year. It previously said it was closing the Morris Plains plant and restructuring its administrative department as part of a $150 million annual cost-cutting plan.

Schiffman called 2012 “a year of transformation” for Dendreon.

“We’ve had some ups and downs, so we certainly learned a lot, but we are continuing to evolve the commercial organization,” he said.

Rox Enrolls Patients

San Clemente-based startup Rox Medical Inc. said it has enrolled its first patient in a randomized, controlled clinical trial of its Flow procedure for treating high blood pressure.

Flow uses a catheter to place a small coupler between the artery and vein in a patient’s upper leg.

It’s designed to reduce peripheral blood vessel resistance, something it says will bring down blood pressure.

“We like the fact that the Rox procedure is reversible and that it can treat patients who are not candidates or don’t seem to respond to renal denervation,” Dr. Neil Sulke, one of the trial’s investigators, said in a news release.

Renal denervation is the traditional treatment for high blood pressure that’s unresponsive to drugs.

Sulke and Dr. Stephan Furniss performed the procedure using Rox’s device at Eastbourne General Hospital in East Sussex in the United Kingdom.

Avanir, VA Team Up

Avanir Pharmaceuticals Inc., an Aliso Viejo-based drug maker, said it’s working with the U.S. Department of Veterans Affairs and United BioSource Corp. in Chevy Chase, Md., to screen some 1,000 veterans with traumatic brain injury for pseudobulbar affect symptoms.

Avanir makes Nuedexta, a drug that’s approved for treating pseudobulbar affect, which involves sudden involuntary outbursts of crying or laughing.

Pseudobulbar affect is often found in patients who have other neurological conditions, including traumatic brain injury, multiple sclerosis, Parkinson’s disease, stroke, Alzheimer’s disease and amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

The drug maker said its goal is to develop screening protocol for identifying and treating veterans with symptoms of pseudobulbar affect.

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