From Forbes.com
Associated Press
Ahead of the Bell: Pharmasset shares rise
Associated Press, 06.03.11, 09:02 AM EDT
NEW YORK -- A Citi Investment Research analyst said Friday that Pharmasset Inc.'s leading hepatitis C drug candidate could be approved sooner than expected, and he nearly tripled his price target on Pharmasset shares.
Shares of the Princeton, N.J., company rose $3.33, or 3.3 percent, to $104.20 in pre-market trading.
Analyst Yaron Werber said the drug candidate, which is designated PSI-7977, could be approved as soon as mid-2014 to treat two relatively rare types of hepatitis C.
Werber previously thought PSI-7977 wouldn't reach the market until late 2015, and he raised his target on Pharmasset ( VRUS - news - people ) to $200 per share from $71 to reflect the chances of an earlier approval, which would boost sales of the drug.
Werber said PSI-7977 could get to the market sooner if it is approved to treat hepatitis C genotypes 2 and 3, which make up a minority of cases. In late May, Pharmasset started a mid-stage clinical trial of PSI-7977 as a treatment for hepatitis C genotypes 1, 2, and 3. Genotype 1 makes up about 70 percent of hepatitis C diagnoses. Werber said he thinks the drug "will have solid data and will be one of the dominant drugs in hepatitis C."
The analyst said Pharmasset should present study data in November and should start late-stage studies in early 2012. He thinks the company will be profitable in 2016.
Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
Friday, June 3, 2011
Monday, May 23, 2011
Vertex's Incivek approved by the FDA....
The second protease inhibitor for HCV was just approved by the FDA, Vertex's Incivek. Should be in pharmacies by the end of the week. Looks like they are offering a pretty aggressive patient assistance program as well.
FDA clears Vertex's hepatitis C drug Incivek
By MARLEY SEAMAN
AP Health Writer
Published: Monday, May. 23, 2011 - 7:17 am
Last Modified: Monday, May. 23, 2011 - 9:18 am
NEW YORK -- The Food and Drug Administration approved Vertex Pharmaceuticals Inc.'s hepatitis C drug Incivek Monday, making it the second new treatment to be approved in the last two weeks.
Incivek is a highly-anticipated pill that is expected to have annual sales in the billions. It is approved for patients who have some liver damage from hepatitis C who either have not been treated, or were not cured by other drugs. Patients on Incivek take two pills three times per day. The Cambridge, Mass., company has already started promoting the drug in advance of approval, and it said Incivek will be available in pharmacies later this week.
The company says a 12-week course of treatment will cost $49,200, compared to $30,000 for standard therapies.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. Vertex said about 4 million people in the U.S. have the disease, and many people do not know they are infected. Hepatitis C can cause liver damage, cirrhosis, liver failure or cancer. Incivek and Merck & Co.'s Victrelis, which was approved earlier this month, are the first new breakthrough treatments for the liver disease to be approved in 20 years.
In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.
Both Incivek and Victrelis block an enzyme that helps the virus reproduce. Incivek is seen as the more effective of the two drugs and is expected to have greater sales. Victrelis is a pill taken three times per day.
The most common side effects of Incivek are fatigue, itching, nausea, diarrhea, vomiting, taste changes, and anal or rectal problems. More serious side effects include rash, anemia, low red blood cell count, and birth defects in pregnant women. The side effects of standard treatments - including the IV drug pegylated interferon and the pill ribavirin - can include months of side effects, but less than half of patients are cured.
Vertex owns the North American marketing rights to Incivek, also known as telaprevir, and is seeking marketing approval in other countries through partnerships, including an agreement with Johnson & Johnson. The company said it has a 115-person sales team to support the drug, and will give Incivek for free to people with no health insurance and annual household income of less than $100,000. It will also cover some co-pay or co-insurance costs.
Shares of Vertex rose 20 cents to $55.20 in midday trading.
Read more: http://www.sacbee.com/2011/05/23/3647497/fda-clears-vertexs-hepatitis-c.html#ixzz1NCDkkUY5
FDA clears Vertex's hepatitis C drug Incivek
By MARLEY SEAMAN
AP Health Writer
Published: Monday, May. 23, 2011 - 7:17 am
Last Modified: Monday, May. 23, 2011 - 9:18 am
NEW YORK -- The Food and Drug Administration approved Vertex Pharmaceuticals Inc.'s hepatitis C drug Incivek Monday, making it the second new treatment to be approved in the last two weeks.
Incivek is a highly-anticipated pill that is expected to have annual sales in the billions. It is approved for patients who have some liver damage from hepatitis C who either have not been treated, or were not cured by other drugs. Patients on Incivek take two pills three times per day. The Cambridge, Mass., company has already started promoting the drug in advance of approval, and it said Incivek will be available in pharmacies later this week.
The company says a 12-week course of treatment will cost $49,200, compared to $30,000 for standard therapies.
Hepatitis C is an infectious disease that is spread through the blood, including by sharing needles or having sex with an infected person. Vertex said about 4 million people in the U.S. have the disease, and many people do not know they are infected. Hepatitis C can cause liver damage, cirrhosis, liver failure or cancer. Incivek and Merck & Co.'s Victrelis, which was approved earlier this month, are the first new breakthrough treatments for the liver disease to be approved in 20 years.
In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks. Vertex said about 79 percent of previously untreated patients were cured after treatment with Incivek. The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs.
Both Incivek and Victrelis block an enzyme that helps the virus reproduce. Incivek is seen as the more effective of the two drugs and is expected to have greater sales. Victrelis is a pill taken three times per day.
The most common side effects of Incivek are fatigue, itching, nausea, diarrhea, vomiting, taste changes, and anal or rectal problems. More serious side effects include rash, anemia, low red blood cell count, and birth defects in pregnant women. The side effects of standard treatments - including the IV drug pegylated interferon and the pill ribavirin - can include months of side effects, but less than half of patients are cured.
Vertex owns the North American marketing rights to Incivek, also known as telaprevir, and is seeking marketing approval in other countries through partnerships, including an agreement with Johnson & Johnson. The company said it has a 115-person sales team to support the drug, and will give Incivek for free to people with no health insurance and annual household income of less than $100,000. It will also cover some co-pay or co-insurance costs.
Shares of Vertex rose 20 cents to $55.20 in midday trading.
Read more: http://www.sacbee.com/2011/05/23/3647497/fda-clears-vertexs-hepatitis-c.html#ixzz1NCDkkUY5
Friday, May 20, 2011
FDA Approves Tibotec's New HIV Treatment, Edurant
FDA Approves Tibotec's New HIV Treatment, Edurant
5/20/2011
SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).
Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.
"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.
Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.
The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.
Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.
For more information:
FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm
FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm
CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm
HHS: AIDS News and Resources
http://www.aids.gov/
AIDS Information
http://www.aidsinfo.nih.gov/
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
5/20/2011
SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).
Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.
"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.
Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.
The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.
Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.
For more information:
FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm
FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm
CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm
HHS: AIDS News and Resources
http://www.aids.gov/
AIDS Information
http://www.aidsinfo.nih.gov/
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Friday, April 29, 2011
FDA advisory panel gives thumbs up to Vertex's Telaprevir...
FDA backs Vertex hepatitis drug efficacy, shares jump
Tue, Apr 26 2011
By Lisa Richwine
WASHINGTON (Reuters) - A hepatitis C drug from Vertex Pharmaceuticals Inc cured more patients than previously reported, U.S. health reviewers said, boosting the approval chances for a pill expected to transform treatment of the liver-destroying disease that afflicts millions.
Vertex shares rose 12 percent to their highest level in a decade after comments from Food and Drug Administration staff on Tuesday that analysts said favored the medicine's approval.
Shares of Merck, whose rival hepatitis C treatment also faces an FDA panel's review this week, rose 2.2 percent.
Both medicines are expected to reap more than $1 billion in sales if approved after demonstrating an ability to cure far more patients than current standard drugs, in some cases in half the time.
Vertex's telaprevir eliminated the hepatitis C virus in 79 percent of newly treated patients, FDA reviewers said. That was higher than the 75 percent Vertex reported earlier because the FDA used a different cure rate calculation.
Analysts said the higher effectiveness, plus few FDA safety concerns, meant an advisory panel would likely recommend approval of the drug on Thursday.
"We now expect telaprevir to get a relatively clean recommendation (and hence approval) with no significant exclusions, restrictions, warnings or caveats," Sanford Bernstein analyst Geoffrey Porges said in a research note.
Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate, with only about a 40 percent success rate. Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
WAITING FOR TREATMENT
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.
Hepatitis C is a bloodborne liver disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. It is spread mainly through reuse of needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. About 3.2 million Americans and 170 million people worldwide have the disease.
Analysts widely expect the Vertex pill to dominate the market with its greater effectiveness. Telaprevir's 79 percent success rate compares with up to 66 percent for Merck's drug, boceprevir, in previously untreated patients. It also had a higher cure rate than the Merck drug in patients who had failed to be helped by prior therapy.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings," FDA staff said in a summary prepared for the advisory panel of outside experts.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
An FDA panel will review the Merck drug on Wednesday. In documents released on Monday, agency reviewers said Merck's drug appeared effective but highlighted anemia and other safety issues for panel discussion.
The FDA usually approves medicines that win advisory panel backing. An approval decision for either drug could come as early as May.
(Additional reporting by Toni Clarke and Bill Berkrot, editing by Michele Gershberg, Gerald E. McCormick, Derek Caney and Bernard Orr)
Tue, Apr 26 2011
By Lisa Richwine
WASHINGTON (Reuters) - A hepatitis C drug from Vertex Pharmaceuticals Inc cured more patients than previously reported, U.S. health reviewers said, boosting the approval chances for a pill expected to transform treatment of the liver-destroying disease that afflicts millions.
Vertex shares rose 12 percent to their highest level in a decade after comments from Food and Drug Administration staff on Tuesday that analysts said favored the medicine's approval.
Shares of Merck, whose rival hepatitis C treatment also faces an FDA panel's review this week, rose 2.2 percent.
Both medicines are expected to reap more than $1 billion in sales if approved after demonstrating an ability to cure far more patients than current standard drugs, in some cases in half the time.
Vertex's telaprevir eliminated the hepatitis C virus in 79 percent of newly treated patients, FDA reviewers said. That was higher than the 75 percent Vertex reported earlier because the FDA used a different cure rate calculation.
Analysts said the higher effectiveness, plus few FDA safety concerns, meant an advisory panel would likely recommend approval of the drug on Thursday.
"We now expect telaprevir to get a relatively clean recommendation (and hence approval) with no significant exclusions, restrictions, warnings or caveats," Sanford Bernstein analyst Geoffrey Porges said in a research note.
Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate, with only about a 40 percent success rate. Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.
WAITING FOR TREATMENT
Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new anti-virals, which still must be taken in combination with the older drugs ribavirin and interferon.
Hepatitis C is a bloodborne liver disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. It is spread mainly through reuse of needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. About 3.2 million Americans and 170 million people worldwide have the disease.
Analysts widely expect the Vertex pill to dominate the market with its greater effectiveness. Telaprevir's 79 percent success rate compares with up to 66 percent for Merck's drug, boceprevir, in previously untreated patients. It also had a higher cure rate than the Merck drug in patients who had failed to be helped by prior therapy.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings," FDA staff said in a summary prepared for the advisory panel of outside experts.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
An FDA panel will review the Merck drug on Wednesday. In documents released on Monday, agency reviewers said Merck's drug appeared effective but highlighted anemia and other safety issues for panel discussion.
The FDA usually approves medicines that win advisory panel backing. An approval decision for either drug could come as early as May.
(Additional reporting by Toni Clarke and Bill Berkrot, editing by Michele Gershberg, Gerald E. McCormick, Derek Caney and Bernard Orr)
Wednesday, April 27, 2011
FDA advisory board gives Boceprevir the green light, FDA final decision will be in mid-May...
FDA Panel Backs Experimental Merck Hepatitis Drug
WASHINGTON April 27, 2011 (AP)
Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck's boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group's recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
WASHINGTON April 27, 2011 (AP)
Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck's boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group's recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
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