Clinical data on Adeza Biomedical Corp.'s Gestiva drug to prevent premature births are adequate for it to win U.S. approval, an advisory panel said on Tuesday, adding that future information on possible risks was needed.
Gestiva is a long-acting, injectable form of the hormone progesterone. Its maker, which specializes in women's health products, is seeking approval from the U.S. Food and Drug Administration to allow the shots for women who have previously given birth prematurely.
Adeza stock rose in afterhours trade to $16.60 a share in after closing at $15.91 on Nasdaq.
There is no FDA-approved drug to prevent premature birth, but injectable progesterone was available in the United States for 50 years for other conditions until Bristol-Myers Squibb Co. stopped selling it in 2000.
Since then pharmacists have been making their own version of the drug, and some doctors have used other drugs known to stop contractions, but not approved to prevent early birth.
The drug, Adeza officials said, could also help curb the growing number of American women who are giving birth before a full pregnancy term of 37 weeks, the company said.
About 12 percent of all babies are born too early, according to the March of Dimes health organization, which said it supported approval as long as Gestiva was closely monitored once on the market.
The FDA panelists said more study should be done to evaluate a possible link between the drug and miscarriages and stillbirths. Most said that could be done after the drug's approval, but eight of the 21 panelists urged the data be collected before.
They also recommended the company establish a patient registry to monitor side-effects as well as consider follow-up studies on possible long-term problems.
The FDA, which usually follows the advice of its panels, is expected make its final decision by Oct. 20.
"FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid," the U.S. insurance program for the poor, added March of Dimes' medical director Dr. Nancy Green. She said her group has accepted funds from Adeza but did not collaborate on its Gestiva proposal.
Preemies are often underweight and can experience a host of other problems, including breathing problems and infections.
FDA staff reviewers said they were concerned the drugmaker submitted only one study on how well the drug worked. It had a widely different account of women who did not take the drug compared with another earlier study, they said, which could raise questions about the trial as a whole.
Adeza's data showed 55 percent of women who took a placebo gave birth early compared with 37 percent in the other study. Both were government-funded.
Some panelists agreed it was not entirely clear how well Gestiva worked, although the panel overall said another trial was not needed.
"Even though I voted for it, I'm still skeptical," said panelist James Scott, a professor of obstetrics and gynecology at the University of Utah School of Medicine.
-----------------------------------------------------
Hana Biosciences (HNAB) was up 2% after the Food and Drug Administration accepted its new drug application for Zensana oral spray for review. Hana wants to get Zensana cleared for preventing the nausea and vomiting that can follow chemotherapy, radiation and operations. Hana was up 14 cents at $7.29.
Canadian biotechnology company Biomira Inc. said Wednesday it named Robert L. Kirkman as president and chief executive, effective Sept. 5.
Kirkman, 57, was formerly acting president and chief executive of biopharmaceutical company Xcyte Therapies Inc. Prior to that appointment, he served as chief business officer and vice president at Xcyte.
Edward A. Taylor, who remains chief financial officer, had been interim president and chief executive since Alex McPherson resigned in May.
Kirkman also becomes a director. In addition, Biomira named Christopher Henney as chairman, effective Sept. 5. Henney joined the board in 2005 and has co-founded three U.S. biotech companies: Immunex, ICOS and Dendreon.
Biomira (BIOM) edged higher .......Biomira was up 1% to $1.12.
PDL BioPharma (PDLI) said Roche has discontinued its involvement in the development of daclizumab in asthma, which both companies had been co-developing since 2004. The decision has no effect on the companies' collaboration to develop daclizumab in transplant maintenance. They plan to proceed with Phase II studies for the transplant indication during 2007. PDL tacked on 1% to $19.68.
Abbott (ABT) completed the enrollment in a study designed to increase the clinical understanding of "vulnerable" plaque -- a lipid-rich coronary plaque that ruptures and is believed to be the cause of most heart attacks. The study enrolled 700 acute coronary syndrome patients receiving stents in the U.S. and Europe. Patients will be followed for at least two, and up to five, years. Shares of Abbott slipped 1.3% to $48.32.
Gestiva is a long-acting, injectable form of the hormone progesterone. Its maker, which specializes in women's health products, is seeking approval from the U.S. Food and Drug Administration to allow the shots for women who have previously given birth prematurely.
Adeza stock rose in afterhours trade to $16.60 a share in after closing at $15.91 on Nasdaq.
There is no FDA-approved drug to prevent premature birth, but injectable progesterone was available in the United States for 50 years for other conditions until Bristol-Myers Squibb Co.
Since then pharmacists have been making their own version of the drug, and some doctors have used other drugs known to stop contractions, but not approved to prevent early birth.
The drug, Adeza officials said, could also help curb the growing number of American women who are giving birth before a full pregnancy term of 37 weeks, the company said.
About 12 percent of all babies are born too early, according to the March of Dimes health organization, which said it supported approval as long as Gestiva was closely monitored once on the market.
The FDA panelists said more study should be done to evaluate a possible link between the drug and miscarriages and stillbirths. Most said that could be done after the drug's approval, but eight of the 21 panelists urged the data be collected before.
They also recommended the company establish a patient registry to monitor side-effects as well as consider follow-up studies on possible long-term problems.
The FDA, which usually follows the advice of its panels, is expected make its final decision by Oct. 20.
"FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid," the U.S. insurance program for the poor, added March of Dimes' medical director Dr. Nancy Green. She said her group has accepted funds from Adeza but did not collaborate on its Gestiva proposal.
Preemies are often underweight and can experience a host of other problems, including breathing problems and infections.
FDA staff reviewers said they were concerned the drugmaker submitted only one study on how well the drug worked. It had a widely different account of women who did not take the drug compared with another earlier study, they said, which could raise questions about the trial as a whole.
Adeza's data showed 55 percent of women who took a placebo gave birth early compared with 37 percent in the other study. Both were government-funded.
Some panelists agreed it was not entirely clear how well Gestiva worked, although the panel overall said another trial was not needed.
"Even though I voted for it, I'm still skeptical," said panelist James Scott, a professor of obstetrics and gynecology at the University of Utah School of Medicine.
-----------------------------------------------------
Hana Biosciences (HNAB) was up 2% after the Food and Drug Administration accepted its new drug application for Zensana oral spray for review. Hana wants to get Zensana cleared for preventing the nausea and vomiting that can follow chemotherapy, radiation and operations. Hana was up 14 cents at $7.29.
Canadian biotechnology company Biomira Inc. said Wednesday it named Robert L. Kirkman as president and chief executive, effective Sept. 5.
Kirkman, 57, was formerly acting president and chief executive of biopharmaceutical company Xcyte Therapies Inc. Prior to that appointment, he served as chief business officer and vice president at Xcyte.
Edward A. Taylor, who remains chief financial officer, had been interim president and chief executive since Alex McPherson resigned in May.
Kirkman also becomes a director. In addition, Biomira named Christopher Henney as chairman, effective Sept. 5. Henney joined the board in 2005 and has co-founded three U.S. biotech companies: Immunex, ICOS and Dendreon.
Biomira (BIOM) edged higher .......Biomira was up 1% to $1.12.
PDL BioPharma (PDLI) said Roche has discontinued its involvement in the development of daclizumab in asthma, which both companies had been co-developing since 2004. The decision has no effect on the companies' collaboration to develop daclizumab in transplant maintenance. They plan to proceed with Phase II studies for the transplant indication during 2007. PDL tacked on 1% to $19.68.
Abbott (ABT) completed the enrollment in a study designed to increase the clinical understanding of "vulnerable" plaque -- a lipid-rich coronary plaque that ruptures and is believed to be the cause of most heart attacks. The study enrolled 700 acute coronary syndrome patients receiving stents in the U.S. and Europe. Patients will be followed for at least two, and up to five, years. Shares of Abbott slipped 1.3% to $48.32.
posted by doublezero at
1:29 PM
0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home