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DNDN after FDA decision on May 15
- Thread starter codedeep007
- Start date
It's a good approval letter, FDA does not want to wait, the FDA director wants to see all the cards now, basically want interm IMPACT data.
"...requested more information about chemistry, manufacturing and controls"
"...requested more information about chemistry, manufacturing and controls"
Why does FDA want manufacturing and controls info, if FDA does not want to approve it now?
"...requested more information about chemistry, manufacturing and controls"
Do you think FDA wants to wait until 2010???
Do you think FDA wants to wait until 2010???
Quote from codedeep007:
"...requested more information about chemistry, manufacturing and controls"
Do you think FDA wants to wait until 2010???
Bloomberg just interviewed the AG Edwards analyst covering the stock; says that this will push the the approval out to late '08 early '09 at the earliest. Stated that the current information is based on hypothesis.
Dendreon Prostate Drug Delayed by U.S.; Shares Plunge (Update7)
By Luke Timmerman
May 9 (Bloomberg) -- Dendreon Corp.'s shares plunged after U.S. regulators said more data is needed to approve the company's prostate cancer medicine Provenge.
The Food and Drug Administration asked for more information supporting Provenge's effectiveness, the Seattle-based company said today in a statement. Dendreon, whose shares had risen fourfold this year, said it is seeking clarification on the request. The stock fell 60 percent.
Provenge would have been the first marketed product for Dendreon since its 1992 founding. The medicine is the first in a new family of drugs that trigger the immune system to attack malignant tumors. While Provenge prolonged lives in advanced cases in one study presented to an FDA advisory panel this year, the drug didn't meet the trial's primary goal of slowing the spread of the disease.
``We are disappointed that this decision will cause a delay in the availability of Provenge for patients who suffer from advanced prostate cancer,'' said Mitchell H. Gold, president and chief executive officer of Dendreon. ``We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner.''
The agency also asked for information on the chemistry and manufacturing of the drug. Dendreon hasn't made any decisions on potential job cuts, said Katherine Stueland, a spokeswoman for the company, in a telephone interview.
Dendreon shares fell $10.64 to $7.10 at 9:33 a.m. New York time in Nasdaq Stock Market composite trading. They started the year at $4.17.
Competitors
Cell Genesys Inc. of South San Francisco, California, and Antigenics Inc. of New York are seeking to develop similar medicines. The treatments are sometimes called ``cancer vaccines'' even though they don't prevent people from contracting the disease.
Analysts estimated that Provenge had U.S. sales potential of about $1 billion a year. Dendreon's only other product in clinical development is an immune-stimulator against breast cancer. The company had an accumulated deficit of $392 million through the end of 2006, according to its annual report.
Patient advocates say demand for Provenge is intense. About 50 percent of men with late-stage prostate cancer said they wouldn't consider chemotherapy because of the side effects, according to a survey of 500 patients, caregivers and doctors in 2005 by US Too International, a patient advocacy group.
Patient Advocate
``With chemotherapy, men lose their hair, throw up and die,'' said Jim Kiefert, a 17-year prostate cancer survivor from Olympia, Washington, who is chairman of Us Too, in a telephone interview. ``This means people will die without getting a chance to try this treatment. I'm very disappointed.''
Dendreon said it had $106 million in cash and investments at the end of December. That's enough to last the company until it can get an interim look at results from an ongoing survival study in the second half of 2008, said David Miller, president of Biotech Stock Research, an independent equity research firm, in a note to clients today.
The company will probably save cash by cutting half of its workforce of 250 employees, Miller said.
Short-Sellers
Many investors had been betting Dendreon would fail to get approval. About 33.9 million shares were held in a short position in April, more than double the number in January, according to data compiled by Bloomberg. Short-sellers try to profit by borrowing stock, selling it, buying back cheaper shares later and pocketing the difference.
Gold sold 202,000 of his shares in the company on April 2, after an FDA advisory panel voted 13-4 in favor of approving Provenge. The shares were sold at about $13.46 a share, according to a filing with the Securities and Exchange Commission. The sale was worth about $2.7 million, at prices more than double from the previous week, before the FDA vote.
The stock sold represented about 20 percent of Gold's holdings in the company, said spokeswoman Monique Greer. It was the first time Gold sold shares in the company, she said in April. The company can now expect shareholder lawsuits over the insider sale, Miller said in his note to clients.
The last drug approved by the FDA to prolong survival in prostate cancer was Taxotere, a chemotherapy drug from Paris- based Sanofi-Aventis SA. That medicine was approved in May 2004. Taxotere showed a median survival edge of 2.5 months compared with patients on another chemotherapy, according to the FDA.
Clinical Trials
Provenge extended patients' lives with few side effects in smaller clinical trials, and Dendreon had hoped it could become an immediate new option for the disease, which kills 27,000 men a year in the U.S.
Dendreon's first trial of 127 men showed that patients on Provenge lived a median 25.9 months, compared with 21.4 months for those on a placebo. A second trial of 98 men showed a median survival of 19 months, compared with 15.7 months for those taking a placebo. That finding wasn't valid because it didn't reach a statistical threshold, the company said.
Both studies failed to show the drug slowed the cancer's spread, which was their primary goal. Dendreon says the measurement of whether Provenge was slowing the cancer's progress may have been carried out too early in the studies to detect the drug's ability to generate an attack by the immune system.
Side Effects
The most common side effects observed were fever and chills that lasted one or two days, according to the company.
The drug, called an immunotherapy, doesn't work like a traditional cancer treatment.
Blood is drawn from a patient, and some white blood cells vital to the immune system are separated in a lab. The white blood cells are shipped to the company and incubated with a genetically engineered protein found on prostate cancer cells. The white blood cells are supposed to recognize the protein as an invader and attack the cells that contain it. The revved-up white blood cells are then sent back and re-infused into the patient.
By Luke Timmerman
May 9 (Bloomberg) -- Dendreon Corp.'s shares plunged after U.S. regulators said more data is needed to approve the company's prostate cancer medicine Provenge.
The Food and Drug Administration asked for more information supporting Provenge's effectiveness, the Seattle-based company said today in a statement. Dendreon, whose shares had risen fourfold this year, said it is seeking clarification on the request. The stock fell 60 percent.
Provenge would have been the first marketed product for Dendreon since its 1992 founding. The medicine is the first in a new family of drugs that trigger the immune system to attack malignant tumors. While Provenge prolonged lives in advanced cases in one study presented to an FDA advisory panel this year, the drug didn't meet the trial's primary goal of slowing the spread of the disease.
``We are disappointed that this decision will cause a delay in the availability of Provenge for patients who suffer from advanced prostate cancer,'' said Mitchell H. Gold, president and chief executive officer of Dendreon. ``We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner.''
The agency also asked for information on the chemistry and manufacturing of the drug. Dendreon hasn't made any decisions on potential job cuts, said Katherine Stueland, a spokeswoman for the company, in a telephone interview.
Dendreon shares fell $10.64 to $7.10 at 9:33 a.m. New York time in Nasdaq Stock Market composite trading. They started the year at $4.17.
Competitors
Cell Genesys Inc. of South San Francisco, California, and Antigenics Inc. of New York are seeking to develop similar medicines. The treatments are sometimes called ``cancer vaccines'' even though they don't prevent people from contracting the disease.
Analysts estimated that Provenge had U.S. sales potential of about $1 billion a year. Dendreon's only other product in clinical development is an immune-stimulator against breast cancer. The company had an accumulated deficit of $392 million through the end of 2006, according to its annual report.
Patient advocates say demand for Provenge is intense. About 50 percent of men with late-stage prostate cancer said they wouldn't consider chemotherapy because of the side effects, according to a survey of 500 patients, caregivers and doctors in 2005 by US Too International, a patient advocacy group.
Patient Advocate
``With chemotherapy, men lose their hair, throw up and die,'' said Jim Kiefert, a 17-year prostate cancer survivor from Olympia, Washington, who is chairman of Us Too, in a telephone interview. ``This means people will die without getting a chance to try this treatment. I'm very disappointed.''
Dendreon said it had $106 million in cash and investments at the end of December. That's enough to last the company until it can get an interim look at results from an ongoing survival study in the second half of 2008, said David Miller, president of Biotech Stock Research, an independent equity research firm, in a note to clients today.
The company will probably save cash by cutting half of its workforce of 250 employees, Miller said.
Short-Sellers
Many investors had been betting Dendreon would fail to get approval. About 33.9 million shares were held in a short position in April, more than double the number in January, according to data compiled by Bloomberg. Short-sellers try to profit by borrowing stock, selling it, buying back cheaper shares later and pocketing the difference.
Gold sold 202,000 of his shares in the company on April 2, after an FDA advisory panel voted 13-4 in favor of approving Provenge. The shares were sold at about $13.46 a share, according to a filing with the Securities and Exchange Commission. The sale was worth about $2.7 million, at prices more than double from the previous week, before the FDA vote.
The stock sold represented about 20 percent of Gold's holdings in the company, said spokeswoman Monique Greer. It was the first time Gold sold shares in the company, she said in April. The company can now expect shareholder lawsuits over the insider sale, Miller said in his note to clients.
The last drug approved by the FDA to prolong survival in prostate cancer was Taxotere, a chemotherapy drug from Paris- based Sanofi-Aventis SA. That medicine was approved in May 2004. Taxotere showed a median survival edge of 2.5 months compared with patients on another chemotherapy, according to the FDA.
Clinical Trials
Provenge extended patients' lives with few side effects in smaller clinical trials, and Dendreon had hoped it could become an immediate new option for the disease, which kills 27,000 men a year in the U.S.
Dendreon's first trial of 127 men showed that patients on Provenge lived a median 25.9 months, compared with 21.4 months for those on a placebo. A second trial of 98 men showed a median survival of 19 months, compared with 15.7 months for those taking a placebo. That finding wasn't valid because it didn't reach a statistical threshold, the company said.
Both studies failed to show the drug slowed the cancer's spread, which was their primary goal. Dendreon says the measurement of whether Provenge was slowing the cancer's progress may have been carried out too early in the studies to detect the drug's ability to generate an attack by the immune system.
Side Effects
The most common side effects observed were fever and chills that lasted one or two days, according to the company.
The drug, called an immunotherapy, doesn't work like a traditional cancer treatment.
Blood is drawn from a patient, and some white blood cells vital to the immune system are separated in a lab. The white blood cells are shipped to the company and incubated with a genetically engineered protein found on prostate cancer cells. The white blood cells are supposed to recognize the protein as an invader and attack the cells that contain it. The revved-up white blood cells are then sent back and re-infused into the patient.
Damn. I knew I should have shorted this.
I hate biotech. Especially small biotech. Shorting it 98% of the time is the right thing.
I hate biotech. Especially small biotech. Shorting it 98% of the time is the right thing.
I don't get this continued fantasy that the FDA director is going to squeeze this through because he's a cancer survivor. It's almost as laughable as the guy on the NFLD board who kept on saying that their blood substitute would be approved (even though it was less effective than the control) simply because the DoD liked it "and the FDA and DoD are both part of the government". The FDA has a million eyes watching it, including people like Grassley, and they won't let personal feelings or political pressure influence them.Quote from codedeep007:
It's a good approval letter, FDA does not want to wait, the FDA director wants to see all the cards now, basically want interm IMPACT data.