Johnson & Johnson Zytiga Study Sets Up Challenge to Dendreon

Johnson & Johnson’s prostate-cancer pill Zytiga became positioned to mount a challenge to Dendreon Corp.’s Provenge after independent monitors said J&J’s medicine was so effective it should be given to all patients in a study.

The findings by monitors of a study of Zytiga in men with advanced prostate cancer who hadn’t begun chemotherapy will enable J&J to go against Provenge, a $93,000 infusion therapy. While some analysts and Dendreon officials say the drugs may be used together, a survey by Christopher Raymond, an analyst at Robert W. Baird & Co. in Chicago, found that most oncologists would prescribe Zytiga. That drug is currently approved for treatment after chemotherapy.

Zytiga safely slowed progression of the disease and reduced the risk of death, New Brunswick, New Jersey-based J&J said today in a statement disclosing it had halted the study so that men currently getting a placebo could receive the drug.

The news is “another positive for Johnson & Johnson’s pharmaceutical franchise, further strengthening the profile of Zytiga, an important growth driver over the next several years,” said Larry Biegelsen, an analyst at Wells Fargo Securities in New York, in a note to clients.

Sales Forecast

“There are roughly twice as many pre-chemotherapy prostate-cancer patients as there are post-chemo patients,” said Biegelsen, who is reviewing his $914 million sales forecast for Zytiga for 2013. He rates J&J shares outperform.

J&J rose less than 1 percent to $64.85 at the close of New York trading, while Seattle-based Dendreon fell 7 percent to $10.12. Medivation Inc., a San Francisco-based biotechnology company developing a drug called MDV3100 that works in a similar manner as Zytiga, rose 14 percent to $72.91.

Fifteen percent of the 218,000 American men a year who are diagnosed with prostate cancer have it spread beyond the walnut-sized gland that lies between the bladder and urethra, according to the National Cancer Institute. Treatments are designed to stop the production of male hormones that fuel the tumor’s growth.

Johnson & Johnson plans to file for regulatory approval of Zytiga in the U.S. and worldwide in the second half of 2012 for use, before chemotherapy, in men with prostate cancer that doesn’t respond to conventional therapies to quell hormone production. Dendreon’s Provenge is also sold to treat those men.

The study, dubbed COU-AA-302, covered 1,088 men with mild or no symptoms from prostate cancer that had spread to other parts of the body and didn’t respond to conventional therapy to stop hormone production. They were given Zytiga once daily plus the steroid prednisone twice daily, or else prednisone plus a placebo.

Unanimous Finding

The independent data-monitoring committee unanimously recommended stopping the study because men given Zytiga had a clinical benefit, with less progression of the cancer, signs of improved survival and a favorable safety profile, the company said. The committee also said patients originally assigned to get the placebo should start receiving Zytiga.

The drug was initially approved in the U.S. in April 2011 for men with advanced prostate cancer that didn’t respond to previous treatment, including chemotherapy.

Each year in the U.S., about 30,000 men are diagnosed with metastatic, treatment-resistant prostate cancer, said Bryan Huang, an analyst at Citi Investment Research in New York. Assuming that Zytiga costs $5,000 a month and that the Medivation drug will reach the market at about the same price, the pre-chemotherapy U.S. market is about $2.4 billion a year, he said in a note.

Fewer than half of patients with advanced disease get chemotherapy, and they would receive treatment for a shorter period of time, Huang wrote. He estimates a post-chemotherapy market of $800 million a year.

“We believe Zytiga and MDV3100 will further squeeze Provenge market due to ease of administration, tangible clinical benefits beyond overall survival and cheaper pricing,” he wrote.



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