Seattle-based biotechnology drug developer Dendreon Corp. now expects to finish a Seal Beach plant by the middle of 2011, a few months earlier than previously thought.
Dendreon is building the plant to produce its Provenge prostate cancer drug candidate. It’s also building a plant in Georgia to produce Provenge.
“Based on the potential for immediate strong demand, the company elected to accelerate the pace of construction at the Georgia and California Provenge manufacturing facilities,” said Joel Sendek, an analyst with New York-based Lazard Capital Markets LLC, in a research report.
Earlier in 2009, Dendreon signed a 10.5-year lease valued at $13.6 million for 184,000 square feet of space in Seal Beach’s Pacific Gateway Business Center off the Garden Grove (22) Freeway.
In December, Dendreon raised $356 million by issuing 15 million shares of its stock. The company could raise $54 million more if a 2.25 million share overallotment is tapped.
Provenge now is being reviewed by the Food and Drug Administration. Regulators already have looked at the drug and indicated it could be approved.
Analyst Sendek said he anticipates approval by May 1. It still is possible but unlikely that Provenge would have to go before an FDA advisory panel, he said.
Dendreon is having ongoing discussions to find a company to market Provenge internationally, Sendek said. He expects an announcement in the early part of 2010, he said.
The drug is designed for men whose prostate cancer is resistant to what’s known as chemical castration hormone therapy, the traditional way to fight advanced forms of the disease.
Provenge works by harnessing a patient’s immune system and spurring white blood cells to attack cancerous cells in the prostate.
Dendreon makes Provenge from white blood cells harvested from individual patients, David Urdal, the company’s chief scientific officer, said earlier this year.
After Dendreon takes each patient’s cells, they are sent to a plant where they are converted to Provenge and then are returned to the doctor’s office.
Motley Nod
Irvine drug maker Spectrum Pharmaceuticals Inc. recently got a nod as a company whose “potential could change in very short order,” according to a December article on the Motley Fool investor Web site.
Author Rich Duprey said that Spectrum’s fortunes could change because its Zevalin drug for treating non-Hodgkin’s lymphoma, a form of blood cancer, was approved in September as “a first-line of defense” against the disease.
Zevalin sales were in excess of $2 million in the first month under its new status, which Duprey said represented 42% of Spectrum’s $7.1 million in third-quarter revenue.
“Extrapolate such monthly sales forward and Zevalin could have a salubrious impact on results,” Duprey said.
Spectrum’s top-line growth should “markedly improve even further” if it’s able to get its Fusilev advanced metastatic colorectal cancer drug to fall in line, he said.
But Fusilev faces challenges. Earlier this year, the FDA sent a letter to Spectrum saying it didn’t see Fusilev as an effective treatment and requested a meeting with the company.
Separately, Spectrum said that it hired Ernst & Young LLP as its independent public accounting firm, replacing Kelly & Co.
Cianna Device Studied
Cianna Medical Inc., an Aliso Viejo medical device maker, said a study done at the Rebecca and John Moores Cancer Center in San Diego showed positive results for its Savi breast cancer device.
The device, which delivers targeted radiation, resulted in fewer complications and opens up treatment to more women, according to the study.
Potential radiation exposure for healthy breast tissue was “exceedingly low,” the study found, because Savi uses multiple catheters to deliver radiation.
Researchers said no serious complications occurred, including no persistent swelling or breast pain, and no local recurrences of cancer.
“With Savi, we seem to have a device that overcomes some of the most significant drawbacks of other methods,” said Catheryn Yashar, the study’s lead author.
Savi’s used in what’s called “breast conservation therapy,” which is lumpectomy surgery to remove cancerous tissue in the breast and follow-up radiation.
Cianna raised $11 million in venture capital earlier this year and has been bulking up its sales staff. The company has touted Savi as a device that can treat a wider range of breast cancer patients, including women with small breasts and with breast implants.
Bits and Pieces:
CLRS Technology, a Costa Mesa-based company that grew out of Aliso Viejo-based technology booster group Octane, said it came out with a version of its Claro SX device for treating acne at some Nordstrom stores, including at South Coast Plaza in Costa Mesa and The Shops at Mission Viejo … Hoag Memorial Hospital Presbyterian in Newport Beach said it was named one of the top 100 U.S. hospitals for heart care by Thomson Reuters Corp. Hoag said it was selected as one of 30 community hospitals measured by the survey, which looked at clinical outcomes for patients diagnosed with heart failure and heart attacks or those who received angioplasties or coronary bypass surgery … International Stem Cell Corp., a biotechnology company just across the county line in Oceanside, said it plans to launch a stem cell-based skincare product line through its Lifeline Skin Care Inc. subsidiary.
