Dendreon Corp. won approval for its only product, the prostate cancer vaccine Provenge, concluding a three-year battle with U.S. regulators to introduce the first therapy to train the body’s immune system to destroy tumors.
Provenge may reap annual sales of $4.3 billion by 2020, said George Farmer, a Canaccord Adams Inc. analyst in New York. Its clearance will also benefit more than a dozen other companies developing drugs in the emerging field of cancer immunotherapy, said Joseph Pantginis, an analyst with Roth Capital Partners in New York.
“This approval represents the first cancer immunotherapy product approved in the U.S. and is truly a landmark event,” Pantginis said in a research report yesterday.
Provenge, cleared yesterday for use against advanced prostate tumors, will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement. It will cost $93,000 for a typical three- dose course of treatment, the company said. At least one insurer, WellPoint Inc., said it may not pay for it.
Food and Drug Administration approval of Provenge “will definitely inform the clinical development programs of other companies” working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston, in a telephone interview before the decision was announced.
The most advanced of these vaccines include Seattle-based Oncothyreon Inc. and German drugmaker Merck KGaA’s Stimuvax for breast and lung malignancies; ipilimumab from Bristol-Myers Squibb Co. of New York, for melanoma; and British drugmaker Oxford BioMedica Plc’s TroVax for prostate, kidney and colorectal cancers.
WellPoint, based in Indianapolis, will wait for “credible scientific evidence” about the effectiveness and medical necessity of Provenge before deciding whether to pay for the drug, Lori McLaughlin, a company spokeswoman, said in an e-mail.
Provenge will almost certainly be covered by the government’s Medicare insurance plan for the elderly and disabled, said Don McLeod, a Center for Medicare and Medicaid Services spokesman. The agency doesn’t typically make formal determinations on cancer drugs. Instead, it pays claims through the local contractors who administer payments.
“It is 99.9 percent certain that we will pay for it if somebody files a claim,” McLeod said in an e-mail. The agency has yet to determine how much it will reimburse for the drug, McLeod said. Dendreon said yesterday that it plans to meet with the agency next week.
Dendreon gained $3.88, or 7.7 percent, to $54.06 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The stock has doubled so far this year.
Provenge also boosted the stocks of companies developing similar products for a variety of tumor types. Oncothyreon rose 12 cents, or 3.1 percent, to $4.04 in Nasdaq trading. Celldex Therapeutics Inc., of Needham, Massachusetts, gained 39 cents, or 5 percent, to $8.17.
“As investors will now ask the inevitable question of ‘who’s next?’ we look to sift through multiple companies also targeting a cancer immunotherapy approach and land on Celldex,” said Pantginis, the Roth Capital analyst.
Celldex is partnered with New York-based Pfizer Inc., the world’s largest drugmaker, on development of CDX-110 for glioblastoma, a common and aggressive form of brain cancer. Celldex will report data in June from the second of three stages of testing generally required for U.S. approval, Pantginis said.
Oncothyreon Chief Executive Officer Robert Kirkman said “we are next in line.” The company may have data on Stimuvax by the end of next year, assuming trials halted by regulators last month are allowed to continue, he said in an April 26 telephone interview.
Development on the Oncothyreon treatment was halted last month after a patient in one trial developed a brain infection while on treatment.
Provenge’s approval may spark large drugmakers to invest in development of Oxford’s cancer vaccine TroVax, CEO John Dawson said today in a telephone interview. He may seek FDA clearance of TroVax for colorectal cancer by 2016 with a $40 million trial in about 1,400 patients.
“This should put things like TroVax back on the radar screen for potential partners,” Dawson said.
Dendreon submitted its application with the FDA in November 2006 and, after winning the backing of an advisory panel in 2007, was required to conduct another study to prove the drug worked. With clearance yesterday, Dendreon said the FDA will require it to monitor 1,500 patients given Provenge for increased risk of strokes seen in studies.
More than 27,000 men die of prostate cancer each year in the U.S., according to American Cancer Society.
Provenge helped men whose prostate cancer had spread to other organs live four months longer in the 512-patient study released by the company in April 2009. The company had initially applied for approval based on an earlier study of 127 men that showed the drug improved survival and a second study of 98 men that failed to show a statistically significant benefit.
“Although people have been experimenting with immune therapy for cancer for decades, the good news is we’re finally starting to see some signs that this is a good approach,” said Richard Schilsky, the chief of hematology at the University of Chicago and immediate past president of the American Society of Clinical Oncology, in an April 23 telephone interview.
The therapy involves extracting white blood cells from a patient, mixing them with vaccine components and injecting the combination back into the person. Provenge is designed to be given earlier in treatment of the cancer and pose fewer side effects than chemotherapy.
“We will be looking at this as an example,” said Massimo Cristofanilli, chairman of the medical oncology department at Fox Chase Cancer Center in Philadelphia, in an interview on April 19. “It will set the stage for how we develop studies. It will also drive even more interest in immune therapies.”