Zytiga creeps up on Provenge prostate-cancer drug

Fri Oct 7, 2011 3:29pm EDT

* Quicker relief, ease of use help Zytiga pill

* Zytiga's fast ramp-up seen hurting Dendreon

* Bavarian Nordic vaccine moving into Phase III trials

By Ransdell Pierson

NEW YORK, Oct 7 (Reuters) - Interest in Dendreon Corp's Provenge vaccine to treat prostate cancer seems to be waning following recent approval of Johnson & Johnson's more-convenient and faster-acting Zytiga treatment, according to some doctors and industry analysts.

"The bloom is off the rose for Provenge because patients are looking for something that can treat them more quickly," and with greater convenience, said Charles Duncan, a biotechnology analyst for JMP Securities.

Although Provenge extended patient lives by an average of about four months in clinical trials, it does not significantly delay progression of symptoms -- including the bone pain which is a hallmark of advanced prostate cancer.

Even so, hopes for Provenge were sky high when U.S. regulators approved it in April 2010 for patients with prostate cancer who had failed to benefit from standard medicines that work by blocking the body's production of testosterone. Some analysts had expected the vaccine, which spurs the immune system to attack prostate cancer cells, to eventually capture annual sales of more than $4 billion.

But Duncan, whose company helped sponsor the "Cancer Immunology: A Long-Awaited Reality" conference in New York on Thursday, said Provenge is likely to generate peak annual sales of no more than $500 million because of shortcomings that have become evident to patients and doctors.

They include the time and inconvenience of extracting white blood cells from patients and sending them off to Dendreon plants, where they are combined with vaccine components. Patients then receive the final product through infusions.

Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center, said many patients and doctors are gravitating instead toward J&J's Zytiga -- a pill approved in recent months for advanced prostate cancer patients that have failed to benefit from chemotherapy.

The drug, known by its chemical name abiraterone, also prolonged life by about four months in clinical trials. But patients experience symptom relief far sooner with it than with Provenge, said Slovin, who was interviewed at the conference sponsored by strategy consulting firm MD Becker Partners LLC.

J&J'S PILL COMING ON STRONG

"Abiraterone is taking the market by storm; there is a much faster effect with it" than Provenge, Slovin said. "Patients feel they're getting something beneficial. Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do."

"The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever. I really don't want to wait. I want to take a pill and go to Florida.' "

Moreover, while Zytiga is expensive -- at about $5,000 a month, usually for eight cycles -- it is far less costly than Provenge.

Dendreon stunned investors in August by withdrawing its own sales forecast for Provenge because it was taking longer than expected for doctors to become comfortable with reimbursement issues for the product, which costs $93,000 for a course of treatment.

"I don't think Provenge will fall out of the arena; I do think it will still be used, but not with the same alacrity as when it first hit our formulary," said Slovin, whose hospital is one of the world's most prestigious cancer centers.

Dr. James Gulley, a director of clinical trials for the National Cancer Institute, said there is a "clear utility" for Provenge.

"Patients love the idea that your immune system is helping you fight cancer," he said. But Gulley said its manufacturing process poses challenges that have no doubt hampered demand for the product. "The vaccine has to be made for each individual patient."

Gulley is leading clinical trials of an experimental vaccine to treat prostate cancer that could be taken out of the freezer and injected into patients -- eliminating the hassles seen with Provenge.

The National Cancer Institute developed the vaccine, called ProstVac, and licensed it to Danish biotechnology company Bavarian Nordic . NCI would be entitled to royalties on sales of the vaccine, which is slated to move into late-stage trials in coming weeks.

Gulley said ProstVac prolonged patient lives by eight months in mid-stage trials -- roughly twice the benefit seen in separate trials of Provenge and Zytiga. But he cautioned that ProstVac's true potential will not be known until its far-larger planned Phase III trials are completed.

He said the vaccine, which coaxes immune system T-cells to attack a protein called Prostate-Specific Antigen (PSA) -- could prove to be a bigger drug than Provenge.

"Here's why: because it is off the shelf. There are no logistical constraints."

Currently, the world's top selling prostate cancer drugs are Taxotere (docetaxel), a chemotherapy sold by Sanofi , and drugs that reduce testosterone, the male hormone that fuels the growth of prostate cancer. They include AstraZeneca Plc's Zoladex and Casodex, and widely-used Lupron.

Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.

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Comments (4)
Can the term, ‘Flying off the shelves’ is supported? As a term for commenting on the amount of prescriptions written for a drug it is extremely vague, unprofessional and just leans toward a feeling of no homework being done or due diligence. How can you publish a broad comment like that or post a quote like that without actual numbers or the research and fact checking to verify it.

Whoa! Pardon me, but I just read the article again and…where did the author’s ‘flying off the shelves’ comment go?
I needed to check a ‘fact’ from the article and it had been removed, with out comment.
Now I know this comment will never be published.

I am glad I copied the story earlier now. This is outrageous.
Shouldn’t Reuters at the least make an editorial note that this comment has been removed for fact checking purposes? Such a comment would need to be that specific. To say it was removed for example, ‘for editorial reasons’ is just about as factual as the original statement. It also stands in contradiction to Reuters own policy. As my opinion above is not stated or implied as being a fact, your author did nothing of the same regarding opinion/fact. Until Reuters censored one of its own

Oct 08, 2011 9:39am EDT  --  Report as abuse
wchuck wrote:
Your “hit piece” against Dendreons Provenge was filled with inaccuracies and obviously written with the agenda of bringing down the share price on Dendreons stock. Many are looking into this infraction and a lawsuit may be forthcoming soon. you would do well to correct your statements or retract the article altogether. People like you need to get the facts right before posting articles that have the potential to hurt a companies share price on false and inacurate reporting. One thing is certain, you have not heard the last of this. Zytiga can only be used before Provenge off label and if so is not covered by insurance. Doubtful at the cost that many would choose this option regardless of how bad they want to “take a pill and go to Florida.” Also you failed to mention the many side eefects that exist using Zytiga opposed to Provenge which has very few minimal side effects, and the fact that Zytiga can only be used after chemo and combined with a steroid. This is just to mention a few of your glaring errors or omissions. Perhaps you will decide to write another article praising the obvious benefits of Provenge to prove that you in fact did not have a clear agenda to destroy the share price. we will be waiting.

Oct 08, 2011 11:06am EDT  --  Report as abuse
m.u. wrote:
Dr. Susan Slovin, an oncologist with Memorial Sloan-Kettering Cancer Center works together with Dr. Howard Scher at this Center.
Dr. Scher, with some others derailed Provenge in 2007 from FDA approval, causing death of many patients, who with Provenge could still be alive.
This very “fine” doctor had this time huge financial conflict of interests and was involved in sale of deadly drug Novacea to Schering-Plough and sale of Zytiga to J&J.
Looks like, he continues in Cancer Center his suspicious activity, this time sending Dr. Susan Slovin as a front woman to undervalue the Provenge, presenting misleading information.

Oct 08, 2011 2:15pm EDT  --  Report as abuse
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