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Warum verliert XOMA heute so stark ?
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die sind ja schon verdammt überkauft - vielleicht ne technische Reaktion.
mfg fips17
mfg fips17
Evidence is mounting that biotech firms Genentech (DNA:NYSE - news) and Xoma (XOMA:Nasdaq - news) will be forced to delay an approval application for their groundbreaking psoriasis drug, Xanelim, according to sources familiar with the drug`s development.
Wall Street expects the companies to file an approval application for Xanelim with the U.S. Food and Drug Administration by the end of this year or in the first quarter of next year. That application would be based on tests already completed. But one of the drug`s principal researchers believes an additional ongoing long-term safety trial is crucial to approval. And that test may not be completed in time.
The Street has high hopes for Xanelim, so any delay in the approval process will be viewed as a major setback for investors. Genentech, with its existing stable of profitable drugs, is largely insulated from any hiccups. But a delay will be especially damaging to Xoma, which has pushed as many drugs to market in the past 20 years as the Boston Red Sox have won World Series. (Answer: Zero.) The company`s shares have jumped more than 200% over the past year in anticipation of Xanelim`s release, and a delay might hurt the company`s chances of raising the cash it will need by the end of next year.
A new crop of highly effective psoriasis drugs could generate sales of as much as $2 billion annually by 2005, mainly because the current treatments for the estimated 5 million Americans who suffer from the painful skin disease are not entirely effective.
Xanelim also has serious competition from a rival drug being developed by Biogen (BGEN:Nasdaq - news). The latter is gearing up to submit that drug, Amevive, to the FDA.
Executives from Genentech and Xoma are downplaying -- but not denying -- that a delay in Xanelim`s FDA filing is possible. The companies have not publicly committed to an FDA filing timetable, saying only that a "decision" to file, or not to file, will be made by the end of this year or the beginning of next year.
That caution, however, hasn`t stopped most sell-side analysts from competing to see who can issue the most bullish forecast on Xanelim. The favorable reports don`t mention the real risk of a serious Xanelim delay for Xoma, which will run out of cash by the end of 2002 and is seeking Wall Street`s help to raise more money.
Understanding why the odds of a Xanelim filing delay are so great requires a short primer on the way the drug works. Psoriasis is actually a disease of the immune system in which T lymphocyte cells go awry. These T-cells invade the skin, releasing chemicals that cause the buildup of excess skin cells, leading to the painful lesions.
Xanelim works by blocking a chemical messenger that "activates" the T-cells and sends them into the skin. The results can be dramatic. Results from a clinical test released in March reported that 31% of patients taking Xanelim by injection for 12 weeks showed a 75% improvement in their psoriasis; 50% of patients showed at least a 50% improvement.
Genentech and Xoma echoed this positive data in preliminary findings released from late-stage Xanelim testing at the end of May.
At Xoma`s annual shareholder meeting on May 30, CEO Jack Castello told assembled investors that "This is the first time in the history of the company that we are able to say that a drug we have been involved in its development has preliminary data which shows that it meets the primary endpoint for efficacy and appears safe."
But there is a problem with the way Xanelim works that the companies are loath to talk about now, and which could force a lengthy delay in that FDA application.
When patients stop taking Xanelim, their psoriasis roars back, sometimes very quickly and severely. The drug`s "short duration of effect," in medical parlance, means sufferers would have to take Xanelim indefinitely. Genentech and Xoma must prove to FDA regulators that the drug is safe for patients to take continuously for the rest of their lives, and that means additional testing is required.
But a one-year study to prove the drug`s long-term safety in patients began only in January and may not be completed in time to meet Wall Street`s expectations for an FDA filing.
Dr. Craig Leonardi, a highly regarded St. Louis dermatologist in private practice and a professor at St. Louis University School of Medicine, is a consultant to Genentech and Xoma who has treated the largest number of patients in the Xanelim trials. He believes that Xanelim works, but the companies must still prove the drug`s long-term safety. His beliefs back up the conclusion of a March 2000 Journal of the Academy of American Dermatology article on Xanelim, which raised issues about possible immune system damage caused by the drug. The article concluded that further long-term studies were needed.
"I think the jury is still out on that [long-term safety] concept," he says. "Psoriasis is a chronic disease, so we need a chronic treatment that patients can take continuously. One way we`re addressing the issues is to conduct another one-year study. We are trying to prove that we can get good control [with Xanelim] without starting and stopping treatment, and prove safety. I commend the companies for doing this trial." (Leonardi doesn`t own stock in Genentech or Xoma.)
Leonardi believes that this extra long-term safety study is essential to Xanelim`s FDA application, a direct contradiction to statements made by Xoma CEO Castello, who said it wasn`t necessary for the drug`s approval.
"It`s rather expensive and a long, drawn-out thing to do, but remember this is a product that is going to market and if we are going to bother to go through all these years to get a product to market, we`d really like to do well," he said. "We are doing a lot more than is required just to get the drug approved," Castello said.
Conventional wisdom on the Street agrees that the extra, long-term safety study isn`t necessary for an FDA filing. "Even without this long-term safety data, I think the filing can go ahead," says Mark Augustine, biotech analyst with U.S. Bancorp Piper Jaffray, who believes Xanelim will head to the FDA in the third quarter of this year. Augustine rates Genentech neutral and Xoma a strong buy, and his firm hasn`t done banking for either company.
Xoma shares have rebounded from around $4 last year to as high as $15.25 this year because of excitement over Xanelim. Shares in the company closed Tuesday at $13.91, awarding Xoma with a $920 million market capitalization.
Under its deal with Genentech, Xoma receives 25% of Xanelim profits, if the drug is approved. These profits, the first for the company, will be used as a springboard to raise more money. The company ended the first quarter with $32.3 million in cash and short-term investments, enough to last through the end of 2002 based on current spending levels.
"This long-term safety study is going to take at least 18 months to complete, so there`s no way Xoma and Genentech can have the data ready for an early FDA submission," says one hedge fund manager, who is short Xoma and has no position in Genentech. The manager anticipates eventual FDA approval, but not until late 2003 or even 2004, a full year after the estimates of most sell-side analysts.
Genentech spokeswoman Wendy Emanuel reiterates that the company and Xoma expect to make a decision on an FDA filing by the end of this year, or in the first quarter of next year.
Xoma spokeswoman Ellen Martin says there is enough long-term safety data in the completed studies to make a decision on an FDA filing.
But Emanuel wouldn`t comment directly on Leonardi`s assertions about the relative importance of the additional, long-term safety testing now underway. And she acknowledges that the company doesn`t have enough information now to say whether a delay is possible.
"You`re asking the right questions, but we just don`t have the answers yet," she says.
Wall Street expects the companies to file an approval application for Xanelim with the U.S. Food and Drug Administration by the end of this year or in the first quarter of next year. That application would be based on tests already completed. But one of the drug`s principal researchers believes an additional ongoing long-term safety trial is crucial to approval. And that test may not be completed in time.
The Street has high hopes for Xanelim, so any delay in the approval process will be viewed as a major setback for investors. Genentech, with its existing stable of profitable drugs, is largely insulated from any hiccups. But a delay will be especially damaging to Xoma, which has pushed as many drugs to market in the past 20 years as the Boston Red Sox have won World Series. (Answer: Zero.) The company`s shares have jumped more than 200% over the past year in anticipation of Xanelim`s release, and a delay might hurt the company`s chances of raising the cash it will need by the end of next year.
A new crop of highly effective psoriasis drugs could generate sales of as much as $2 billion annually by 2005, mainly because the current treatments for the estimated 5 million Americans who suffer from the painful skin disease are not entirely effective.
Xanelim also has serious competition from a rival drug being developed by Biogen (BGEN:Nasdaq - news). The latter is gearing up to submit that drug, Amevive, to the FDA.
Executives from Genentech and Xoma are downplaying -- but not denying -- that a delay in Xanelim`s FDA filing is possible. The companies have not publicly committed to an FDA filing timetable, saying only that a "decision" to file, or not to file, will be made by the end of this year or the beginning of next year.
That caution, however, hasn`t stopped most sell-side analysts from competing to see who can issue the most bullish forecast on Xanelim. The favorable reports don`t mention the real risk of a serious Xanelim delay for Xoma, which will run out of cash by the end of 2002 and is seeking Wall Street`s help to raise more money.
Understanding why the odds of a Xanelim filing delay are so great requires a short primer on the way the drug works. Psoriasis is actually a disease of the immune system in which T lymphocyte cells go awry. These T-cells invade the skin, releasing chemicals that cause the buildup of excess skin cells, leading to the painful lesions.
Xanelim works by blocking a chemical messenger that "activates" the T-cells and sends them into the skin. The results can be dramatic. Results from a clinical test released in March reported that 31% of patients taking Xanelim by injection for 12 weeks showed a 75% improvement in their psoriasis; 50% of patients showed at least a 50% improvement.
Genentech and Xoma echoed this positive data in preliminary findings released from late-stage Xanelim testing at the end of May.
At Xoma`s annual shareholder meeting on May 30, CEO Jack Castello told assembled investors that "This is the first time in the history of the company that we are able to say that a drug we have been involved in its development has preliminary data which shows that it meets the primary endpoint for efficacy and appears safe."
But there is a problem with the way Xanelim works that the companies are loath to talk about now, and which could force a lengthy delay in that FDA application.
When patients stop taking Xanelim, their psoriasis roars back, sometimes very quickly and severely. The drug`s "short duration of effect," in medical parlance, means sufferers would have to take Xanelim indefinitely. Genentech and Xoma must prove to FDA regulators that the drug is safe for patients to take continuously for the rest of their lives, and that means additional testing is required.
But a one-year study to prove the drug`s long-term safety in patients began only in January and may not be completed in time to meet Wall Street`s expectations for an FDA filing.
Dr. Craig Leonardi, a highly regarded St. Louis dermatologist in private practice and a professor at St. Louis University School of Medicine, is a consultant to Genentech and Xoma who has treated the largest number of patients in the Xanelim trials. He believes that Xanelim works, but the companies must still prove the drug`s long-term safety. His beliefs back up the conclusion of a March 2000 Journal of the Academy of American Dermatology article on Xanelim, which raised issues about possible immune system damage caused by the drug. The article concluded that further long-term studies were needed.
"I think the jury is still out on that [long-term safety] concept," he says. "Psoriasis is a chronic disease, so we need a chronic treatment that patients can take continuously. One way we`re addressing the issues is to conduct another one-year study. We are trying to prove that we can get good control [with Xanelim] without starting and stopping treatment, and prove safety. I commend the companies for doing this trial." (Leonardi doesn`t own stock in Genentech or Xoma.)
Leonardi believes that this extra long-term safety study is essential to Xanelim`s FDA application, a direct contradiction to statements made by Xoma CEO Castello, who said it wasn`t necessary for the drug`s approval.
"It`s rather expensive and a long, drawn-out thing to do, but remember this is a product that is going to market and if we are going to bother to go through all these years to get a product to market, we`d really like to do well," he said. "We are doing a lot more than is required just to get the drug approved," Castello said.
Conventional wisdom on the Street agrees that the extra, long-term safety study isn`t necessary for an FDA filing. "Even without this long-term safety data, I think the filing can go ahead," says Mark Augustine, biotech analyst with U.S. Bancorp Piper Jaffray, who believes Xanelim will head to the FDA in the third quarter of this year. Augustine rates Genentech neutral and Xoma a strong buy, and his firm hasn`t done banking for either company.
Xoma shares have rebounded from around $4 last year to as high as $15.25 this year because of excitement over Xanelim. Shares in the company closed Tuesday at $13.91, awarding Xoma with a $920 million market capitalization.
Under its deal with Genentech, Xoma receives 25% of Xanelim profits, if the drug is approved. These profits, the first for the company, will be used as a springboard to raise more money. The company ended the first quarter with $32.3 million in cash and short-term investments, enough to last through the end of 2002 based on current spending levels.
"This long-term safety study is going to take at least 18 months to complete, so there`s no way Xoma and Genentech can have the data ready for an early FDA submission," says one hedge fund manager, who is short Xoma and has no position in Genentech. The manager anticipates eventual FDA approval, but not until late 2003 or even 2004, a full year after the estimates of most sell-side analysts.
Genentech spokeswoman Wendy Emanuel reiterates that the company and Xoma expect to make a decision on an FDA filing by the end of this year, or in the first quarter of next year.
Xoma spokeswoman Ellen Martin says there is enough long-term safety data in the completed studies to make a decision on an FDA filing.
But Emanuel wouldn`t comment directly on Leonardi`s assertions about the relative importance of the additional, long-term safety testing now underway. And she acknowledges that the company doesn`t have enough information now to say whether a delay is possible.
"You`re asking the right questions, but we just don`t have the answers yet," she says.
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