Dendreon Pharmaceuticals, a developer of a cell-based cancer immunotherapy for prostate cancer that employs nearly 200 people at its Seal Beach headquarters, is putting its lead product to the test. It entered into a research collaboration with San Diego’s Decipher Biosciences, which says it has the world’s largest shared genomic database in urologic cancer.
As part of the agreement, Dendreon will provide tumor samples from prostate cancer patients and Decipher will use its technology platform—whole transcriptome Decipher assay and GRID software and database—to evaluate the effectiveness of Dendreon’s therapy.
“More than 50,000 men choose active surveillance every year, which includes regular monitoring to ensure the [prostate] cancer is not growing or spreading,” Dendreon Chief Medical Officer Dr. Bruce Brown said.
The treatment should enable more patients to stay in the active surveillance cohort longer, and not have to move into “more serious treatment options that can negatively impact quality of life,” he said.
Dendreon makes Provenge, an immunotherapy for prostate cancer. The treatment, initially approved in 2010, was the first FDA-approved immunotherapy made from a patient’s own immune cells. It remains the only therapy of its type for advanced prostate cancer.
Last year, the company launched ProVent trial to show that its therapy can reduce prostate cancer disease progression. The trial, which began late last year, plans to enroll 450 patients and is actively recruiting.
Decipher’s tests are used by physicians to categorize patients into risk groups to help determine which patients may benefit from additional treatment.
Glaucoma Drug Gets FDA Approval
Aerie Pharmaceuticals Inc. (Nasdaq: AERI) recently received Food and Drug Administration approval of its second glaucoma drug, Rocklatan, on March 13.
Shares of the drugmaker climbed more than 7% following the approval, and currently trade at $47.51 for a $2.3 billion market cap.
Aerie, which last year moved its headquarters to North Carolina, maintains operations in Irvine with regulatory, commercial support and other administrative activities at its 37,300-square-foot facility.
Rocklatan is designed to reduce elevated intraocular pressure in patients with open-angle glaucoma or hypertension, according to the company. The once-daily eye drop is a fixed-dose combination of latanprost, the most widely-prescribed eye drop drug to treat glaucoma, and netarsudil, the active ingredient in Aerie’s other glaucoma drug Rhopressa.
Glaucoma, characterized by abnormally high pressure in the eyes, damages optic nerves and is one of the leading causes of blindness for people over the age of 60.
Aerie received FDA approval of Rhopressa in December 2017. The product launched in U.S. last April and the company reported its first-ever sales, reporting $24.2 million. Its 2019 sales are projected to more than quadruple to $114.5 million, according to the average estimate of 10 analysts surveyed by Yahoo Finance.
The company plans to unveil Rocklatan in the U.S. in the second quarter.
Orphan Drug Status for Espero
Espero BioPharma Inc., a developer of treatments for thrombosis and cardiac rhythm control with some operations in Irvine, said the FDA has granted orphan drug designation for its lead drug, Tecarfarin.
The drug is designed to prevent systemic thromboembolism, a blood clot in the heart, in patients with atrial fibrillation or chronic kidney disease.
Orphan drug status is designed to encourage companies to develop drugs for diseases that affect fewer than 200,000 persons in the U.S. The advantages include lower R&D costs due to smaller clinical trials and expedited regulatory reviews.
The presence of either chronic kidney disease or atrial fibrillation increases the risk of serious thromboembolic events, such as stroke and death.
Tecarfarin is a clinical-stage vitamin K substance taken orally once a day as an anticoagulant, or blood thinner.
The pharmaceutical company, which is headquartered in Jacksonville, Fla., has Irvine operations that focus on finance and clinical operations.
People News
Aliso Viejo’s CathWorks recently named Mike Feher as vice president of finance and chief financial officer. His appointment coincided with the company’s U.S. commercialization of its CathWorks FFRangio Coronary Vascular Physiologic Stimulation System. The device received FDA clearance in December.
Feher was most recently senior manager of investor relations at Edwards Lifesciences Corp. (NYSE: EW) in Irvine.
CathWorks is focused on a nonsurgical procedure used to treat narrowing of the coronary arteries.
