Signs agreement with Medicines Patent Pool and Bristol-Myers Squibb
Natco Pharma Ltd has signed an agreement to manufacture and sell generic
version of Bristol-Myers Squibb’s chronic hepatitis C medicine
Daclatasvir Dihydrochloride.
Announcing on Thursday the signing of a “non-exclusive, royalty free
licensing agreement with the Medicines Patent Pool and Bristol-Myers
Squibb,” the company said it will market generic Daclatasvir under its
NATDAC brand and through strategic partners in India.
The agreement allows Natco to provide access to these chronic hepatitis C
medicines in 112 developing countries.
Under the licence, the company can set its own price for the generic
products it produces.
Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the
first-in-class NS5A inhibitor used in combination with Sofosbuvir for
the treatment of patients with chronic hepatitis C virus (HCV) genotype 3
infection, according to a release.. . .
Price, Service and Quality is what we take pride in.
Saturday, January 23, 2016
293 patients possibly exposed to hepatitis, HIV at Baystate Noble Hospital from colonoscopies
WESTFIELD, Mass.–Baystate Noble Hospital is alerting patients to the
possibility that they may have been exposed to blood-borne illnesses
such as hepatitis and HIV.
Between June 11, 2012 and April 17, 2013 the hospital performed colonoscopies on 293 patients, but did not properly disinfect the colonoscopes after use. At that time, Noble Hospital was not part of the Baystate Health network, which it joined in July 2015.
“On behalf of Baystate Noble Hospital and Baystate Health, I apologize to all those affected by this failure in safety,” said Ronald Bryant, the hospital’s president. “The safety of our patients is our very highest priority, and we take full responsibility for our part in allowing these patients to have potentially received unsafe care.”
The issue arose after the hospital in Westfield, Massachusetts began using new colonoscopes, which had a different disinfection process thanthe one previously used instruments required. A failure in training led to an issue in which “the disinfection of those endoscopes between procedures did not adequately expose the devices’ single water irrigation channel to high-level disinfection during the last phase of cleaning.”
The hospital took steps to fix the issue in April 2013, but were not aware of the potential risk to patients until the Massachusetts Department of Public Health notified the hospital in December 2015.
The hospital sent out letters by certified overnight mail on January 20 to all patients. However, if you don’t get a letter and believe you may be at risk, you can call
413-794-8955 FREE.
If you get a letter, follow the directions included to get a screening at the hospital for hepatitis B, hepatitis C and HIV, which will be provided at no cost to the patient. Also, if you don’t have a way to get to the hospital, the team will help you either find transportation or make different arrangements to get screened.
The hospital says the risk to patients is very small, but they want to take every precaution.
Dr. Sarah Haessler, an infectious-disease doctor and Baystate’s head epidemiologist, said the risk of infection is low. “Due to the function of the water irrigation channel and the phase of disinfection at which the failure occurred, the risk to patients is very low. However, that risk is not zero, so we’re taking the necessary steps to address these issues and provide patients with the resources they need.”
Between June 11, 2012 and April 17, 2013 the hospital performed colonoscopies on 293 patients, but did not properly disinfect the colonoscopes after use. At that time, Noble Hospital was not part of the Baystate Health network, which it joined in July 2015.
“On behalf of Baystate Noble Hospital and Baystate Health, I apologize to all those affected by this failure in safety,” said Ronald Bryant, the hospital’s president. “The safety of our patients is our very highest priority, and we take full responsibility for our part in allowing these patients to have potentially received unsafe care.”
The issue arose after the hospital in Westfield, Massachusetts began using new colonoscopes, which had a different disinfection process thanthe one previously used instruments required. A failure in training led to an issue in which “the disinfection of those endoscopes between procedures did not adequately expose the devices’ single water irrigation channel to high-level disinfection during the last phase of cleaning.”
The hospital took steps to fix the issue in April 2013, but were not aware of the potential risk to patients until the Massachusetts Department of Public Health notified the hospital in December 2015.
The hospital sent out letters by certified overnight mail on January 20 to all patients. However, if you don’t get a letter and believe you may be at risk, you can call
413-794-8955 FREE.If you get a letter, follow the directions included to get a screening at the hospital for hepatitis B, hepatitis C and HIV, which will be provided at no cost to the patient. Also, if you don’t have a way to get to the hospital, the team will help you either find transportation or make different arrangements to get screened.
The hospital says the risk to patients is very small, but they want to take every precaution.
Dr. Sarah Haessler, an infectious-disease doctor and Baystate’s head epidemiologist, said the risk of infection is low. “Due to the function of the water irrigation channel and the phase of disinfection at which the failure occurred, the risk to patients is very low. However, that risk is not zero, so we’re taking the necessary steps to address these issues and provide patients with the resources they need.”
Simeprevir Plus Sofosbuvir (12 and 8 Weeks) in HCV Genotype 1-Infected Patients Without Cirrhosis: OPTIMIST-1, a Phase 3, Randomized Study
Abstract
Effective antiviral therapy is essential for achieving sustained virological response (SVR) in hepatitis C virus (HCV)-infected patients. The phase 2 COSMOS study reported high SVR rates in treatment-naïve and prior null-responder HCV genotype (GT)1-infected patients receiving simeprevir+sofosbuvir±ribavirin for 12/24 weeks. OPTIMIST-1 (NCT02114177) was a multicenter, randomized, open-label study assessing the efficacy and safety of 12 and 8 weeks of simeprevir+sofosbuvir in HCV GT1-infected treatment-naïve and -experienced patients without cirrhosis. Patients were randomly assigned (1:1; stratified by HCV GT/subtype and presence/absence of NS3 Q80K polymorphism [GT1b, GT1a with Q80K, GT1a without Q80K]), prior HCV treatment history, and IL28B GT [CC, non-CC]) to simeprevir 150 mg once daily (QD)+sofosbuvir 400 mg QD for 12 or 8 weeks. Primary efficacy endpoint: SVR rate 12 weeks after end of treatment (SVR12). Superiority in SVR12 was assessed for simeprevir+sofosbuvir at 12 and 8 weeks versus a composite historical control SVR rate. 310 patients were enrolled, randomized, and received treatment (n=155 in each arm). SVR12 with simeprevir+sofosbuvir for 12 weeks (97% [150/155; 95% CI 94-100%]) was superior to the historical control (87%). SVR12 with simeprevir+sofosbuvir for 8 weeks (83% [128/155; 95% CI 76-89%]) was not superior to the historical control (83%). The most frequent adverse events (AEs) were nausea, headache, and fatigue (12-week arm: 15% [23/155]), 14% [22/155], and 12% [19/155]; 8-week arm: 9% [14/155], 17% [26/155], and 15% [23/155], respectively). No patients discontinued treatment due to an AE. One (1%; 12-week arm) and three (2%; 8-week arm) patients experienced a serious AE (all unrelated to study treatment). Conclusion: Simeprevir+sofosbuvir for 12 weeks is highly effective in the treatment of HCV GT1-infected, non-cirrhotic patients, including those with Q80K. This article is protected by copyright. All rights reserved.OPTIMIST-1 Study Results Show Favorable HCV GT1 Combo Therapy
Treatment with simeprevir + sofosbuvir for 12 weeks was highly effective in patients with hepatitis C virus (HCV) genotype (GT) 1 infection without cirrhosis, including those with Q80K, a new study published in Hepatology reported.
Data from the Phase 2 COSMOS study showed high sustained virological response (SVR) rates in treatment-naive and prior null-responder HCV GT1-infected patients receiving simeprevir + sofosbuvir with or without ribavirin for 12/24 weeks.
RELATED: Hepatitis C Virus Treatments
OPTIMIST-1 (n=310) was a multi-center, randomized, open-label study that evaluated the safety and efficacy of simeprevir + sofosbuvir in HCV GT1-infected treatment-naive and treatment-experienced patients without cirrhosis. Study patients were randomized to simeprevir 150mg once daily + sofosbuvir 400mg once daily for 12 or 8 weeks. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). SVR12 superiority was compared against a composite historical control SVR rate.
Data showed that SVR12 with simeprevir + sofosbuvir for 12 weeks was superior to the historical control (97% vs. 87%). Treatment for 8 weeks, however, was not superior compared to the historical control (83% vs. 83%). Study authors noted the most frequent adverse events were nausea, headache, and fatigue. One patient in the 12-week arm and 3 patients in the 8-week arm experienced a serious adverse event unrelated to study treatment. Study findings support that simeprevir + sofosbuvir for 12 weeks in patients with HCV GT1 infection without cirrhosis is highly effective.
Sofosbuvir, a HCV NS5B polymerase inhibitor, is indicated for the treatment of genotype 1, 2, 3, or 4 HCV infection as part of a combination antiviral treatment regimen. Simeprevir, a HCV NS3/4A protease inhibitor, is indicated for chronic hepatitis C genotype 1 infection as part of a combination antiviral treatment regimen.
Data from the Phase 2 COSMOS study showed high sustained virological response (SVR) rates in treatment-naive and prior null-responder HCV GT1-infected patients receiving simeprevir + sofosbuvir with or without ribavirin for 12/24 weeks.
RELATED: Hepatitis C Virus Treatments
OPTIMIST-1 (n=310) was a multi-center, randomized, open-label study that evaluated the safety and efficacy of simeprevir + sofosbuvir in HCV GT1-infected treatment-naive and treatment-experienced patients without cirrhosis. Study patients were randomized to simeprevir 150mg once daily + sofosbuvir 400mg once daily for 12 or 8 weeks. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12). SVR12 superiority was compared against a composite historical control SVR rate.
Data showed that SVR12 with simeprevir + sofosbuvir for 12 weeks was superior to the historical control (97% vs. 87%). Treatment for 8 weeks, however, was not superior compared to the historical control (83% vs. 83%). Study authors noted the most frequent adverse events were nausea, headache, and fatigue. One patient in the 12-week arm and 3 patients in the 8-week arm experienced a serious adverse event unrelated to study treatment. Study findings support that simeprevir + sofosbuvir for 12 weeks in patients with HCV GT1 infection without cirrhosis is highly effective.
Sofosbuvir, a HCV NS5B polymerase inhibitor, is indicated for the treatment of genotype 1, 2, 3, or 4 HCV infection as part of a combination antiviral treatment regimen. Simeprevir, a HCV NS3/4A protease inhibitor, is indicated for chronic hepatitis C genotype 1 infection as part of a combination antiviral treatment regimen.
Medicaid Patients Denied Harvoni Treatment
Indianapolis, INAlthough most of the news regarding denied Harvoni insurance claims
and resulting lawsuits involves private insurance providers, it appears
Medicaid is also denying patients necessary Harvoni treatment. Patients
allege Medicaid and other insurance providers are playing with their
lives by deeming the hepatitis C treatment not medically necessary.
NPR (12/27/15) reports that Sarah Jackson was prescribed Harvoni treatment for her hepatitis C, but Indiana’s Medicaid program refused to pay for it. Harvoni costs around $95,000 for a 12-week course - incentive for insurance providers to deny coverage - but it has a more than a 90 percent success rate. That’s a high success rate for a condition that can cause serious liver problems and even death.
According to NPR, however, at least 34 states will not pay for Harvoni treatment unless a patient already has liver damage, a consequence of hepatitis C. A study published in the Annals of Internal Medicine (6/30/15) found that 42 states including the District of Columbia have public information about their Medicaid reimbursement criteria for sofosbuvir (the generic name for Sovaldi, a similar drug to Harvoni). Of those, 74 percent limit access to patients who have advanced liver disease. Nine states have unknown criteria. Nevada is the only state in which it is public information that there is no prior authorization required for sofosbuvir.
In other words, patients who have a disease that could cause severe liver damage have to show enough liver damage to warrant treatment before they are given access to the treatment that could prevent liver damage in the first place.
The US Senate Finance Committee has weighed in, criticizing Gilead Sciences - maker of Sovaldi and Harvoni - for basing the price of the drugs on maximizing revenue.
Sovaldi costs $1,000 per pill or $84,000 for a full treatment. According to a letter from the committee, in the 18 months following Sovaldi’s approval on the market, Medicare spent an estimated $8.2 billion on Sovaldi and Harvoni.
“Gilead pursued a calculated scheme for pricing and marketing its
Hepatitis C drug based on one primary goal, maximizing revenue,
regardless of the human consequences,” Senator Ron Wyden (D-Ore) said.
“Gilead knew these prices would put treatment out of the reach of
millions and cause extraordinary problems for Medicare and Medicaid, but
still the company went ahead.”
For now, patients are left to fight with Medicaid and other insurance providers to try to get the treatment they desperately need, while insurance providers continue to demand evidence of sufficient liver damage before they approve treatment. According to NPR, Sarah Jackson has filed a lawsuit with the help of the ACLU of Indiana, arguing that Medicaid is legally obligated to pay for any drug a doctor deems medically necessary.
NPR (12/27/15) reports that Sarah Jackson was prescribed Harvoni treatment for her hepatitis C, but Indiana’s Medicaid program refused to pay for it. Harvoni costs around $95,000 for a 12-week course - incentive for insurance providers to deny coverage - but it has a more than a 90 percent success rate. That’s a high success rate for a condition that can cause serious liver problems and even death.
According to NPR, however, at least 34 states will not pay for Harvoni treatment unless a patient already has liver damage, a consequence of hepatitis C. A study published in the Annals of Internal Medicine (6/30/15) found that 42 states including the District of Columbia have public information about their Medicaid reimbursement criteria for sofosbuvir (the generic name for Sovaldi, a similar drug to Harvoni). Of those, 74 percent limit access to patients who have advanced liver disease. Nine states have unknown criteria. Nevada is the only state in which it is public information that there is no prior authorization required for sofosbuvir.
In other words, patients who have a disease that could cause severe liver damage have to show enough liver damage to warrant treatment before they are given access to the treatment that could prevent liver damage in the first place.
The US Senate Finance Committee has weighed in, criticizing Gilead Sciences - maker of Sovaldi and Harvoni - for basing the price of the drugs on maximizing revenue.
Sovaldi costs $1,000 per pill or $84,000 for a full treatment. According to a letter from the committee, in the 18 months following Sovaldi’s approval on the market, Medicare spent an estimated $8.2 billion on Sovaldi and Harvoni.
For now, patients are left to fight with Medicaid and other insurance providers to try to get the treatment they desperately need, while insurance providers continue to demand evidence of sufficient liver damage before they approve treatment. According to NPR, Sarah Jackson has filed a lawsuit with the help of the ACLU of Indiana, arguing that Medicaid is legally obligated to pay for any drug a doctor deems medically necessary.
Natco Pharma gains on inking agreement with MPP and Bristol-Myers Squibb for Daclatasvir
Natco Pharma is currently trading at Rs 532.00, up by 12.10 points or 2.33% from its previous closing of Rs 519.90 on the BSE.
The scrip opened at Rs 529.95 and has touched a high and low of Rs 538.00 and Rs 522.00 respectively. So far 13087 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 623.60 on 05-Jan-2016 and a 52 week low of Rs. 265.98 on 26-Feb-2015.
Last one week high and low of the scrip stood at Rs. 560.00 and Rs. 458.05 respectively. The current market cap of the company is Rs. 9243.43 crore.
The promoters holding in the company stood at 51.31% while Institutions and Non-Institutions held 26.41% and 22.28% respectively.
Natco Pharma has signed a nonexclusive, royalty free licensing agreement with the Medicines Patent Pool (MPP) and Bristol-Myers Squibb to manufacture and sell generic versions of Bristol-Myers Squibb’s chronic hepatitis C medicine – Daclatasvir Dihydrochloride (Daclatasvir).
Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets. The company will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India.
This agreement allows the company to expand access to these chronic hepatitis C medicines in 112 developing countries. Under the license, Natco can set its own price for the generic products it produces.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
- See more at:
http://money.livemint.com/news/market/equity/movers-today/natco-pharma-gains-on-inking-agreement-with-mpp-and-bristol-myers-squibb-for-daclatasvir--423309.aspx#sthash.YrgNihBc.dpuf
The scrip opened at Rs 529.95 and has touched a high and low of Rs 538.00 and Rs 522.00 respectively. So far 13087 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 623.60 on 05-Jan-2016 and a 52 week low of Rs. 265.98 on 26-Feb-2015.
Last one week high and low of the scrip stood at Rs. 560.00 and Rs. 458.05 respectively. The current market cap of the company is Rs. 9243.43 crore.
The promoters holding in the company stood at 51.31% while Institutions and Non-Institutions held 26.41% and 22.28% respectively.
Natco Pharma has signed a nonexclusive, royalty free licensing agreement with the Medicines Patent Pool (MPP) and Bristol-Myers Squibb to manufacture and sell generic versions of Bristol-Myers Squibb’s chronic hepatitis C medicine – Daclatasvir Dihydrochloride (Daclatasvir).
Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets. The company will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India.
This agreement allows the company to expand access to these chronic hepatitis C medicines in 112 developing countries. Under the license, Natco can set its own price for the generic products it produces.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
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To Change Drug Policy, First Change the Way You Measure It
As we approach the United Nations General Assembly Special Session on
the World Drug Problem (UNGASS), the voices clamoring for drug policy
reform are getting louder. But within the narrow parameters of the UN
system, what does reform really mean? After all, when it comes to drug
policy, one of the main tasks of the UN is to ensure compliance with
international treaties related to drug use, and to provide a framework
for evaluation so that countries can assess the impact their policies
are making on drug use and supply.
So is all the anticipation over UNGASS misplaced, given the UN's emphasis on evaluation rather than reform? Not exactly. It's become clear that the way countries evaluate their drug policies dictates the kinds of outcomes that governments are seeking to highlight. Simply put, reform begins with taking a hard look at what governments themselves are prioritizing in their drug policy evaluations.
For example, are they more interested in the amount of illegal drugs
that law enforcement officers seize annually, or on the proportion of
their citizens with some kind of substance use disorder? Are they more
interested in determining the price of illegal drugs, or in the number
of people who inject drugs that are infected with HIV or hepatitis C?
In both of the aforementioned examples, governments more often than not prioritize the first metric. And yet, those first metrics tell us very little about how drug policies impact communities in the real world. What's increasingly clear, then, is that to attain the drug policy-related outcomes we want to see, UN agencies and countries all over the world must begin with revising the metrics they use to evaluate drug policy.
That's why scientists from around the world have released an open letter calling for UNGASS to include a formal commitment by UN agencies and member states to use a wider and more relevant set of metrics in evaluating their drug policies. The key is to ensure the relevance of these metrics to communities affected by drugs and drug policies, so that policies reflect community needs and values.
For instance, in the current status quo, officials see high numbers of people incarcerated for drug crimes as a sign of policy success. But focusing on that metric leads to policies that prioritize seizing drugs over treating the harms of drug addiction. It's likely that measuring the proportion of people with substance use disorders who have access to evidence-based treatment will tell us much more about how drugs are affecting communities, and how effective the policy response is.
This is just one example of how, to ensure a sustained commitment to reform, the UN must commit to re-assessing how it conceives of success and failure when it comes to drugs and drug-related harms. That commitment starts with the metrics that UN agencies and member states use to evaluate drug policy. With such a commitment, the process will lead the global community to the creation of drug policies that prioritize health, safety, development, and human rights.
Members of the public are invited to join scientists in demanding that drug policies match community needs by adding their names in support of the open letter. They can also voice their top concerns when it comes to drug policy by filling out the online poll.
So is all the anticipation over UNGASS misplaced, given the UN's emphasis on evaluation rather than reform? Not exactly. It's become clear that the way countries evaluate their drug policies dictates the kinds of outcomes that governments are seeking to highlight. Simply put, reform begins with taking a hard look at what governments themselves are prioritizing in their drug policy evaluations.
In both of the aforementioned examples, governments more often than not prioritize the first metric. And yet, those first metrics tell us very little about how drug policies impact communities in the real world. What's increasingly clear, then, is that to attain the drug policy-related outcomes we want to see, UN agencies and countries all over the world must begin with revising the metrics they use to evaluate drug policy.
That's why scientists from around the world have released an open letter calling for UNGASS to include a formal commitment by UN agencies and member states to use a wider and more relevant set of metrics in evaluating their drug policies. The key is to ensure the relevance of these metrics to communities affected by drugs and drug policies, so that policies reflect community needs and values.
For instance, in the current status quo, officials see high numbers of people incarcerated for drug crimes as a sign of policy success. But focusing on that metric leads to policies that prioritize seizing drugs over treating the harms of drug addiction. It's likely that measuring the proportion of people with substance use disorders who have access to evidence-based treatment will tell us much more about how drugs are affecting communities, and how effective the policy response is.
This is just one example of how, to ensure a sustained commitment to reform, the UN must commit to re-assessing how it conceives of success and failure when it comes to drugs and drug-related harms. That commitment starts with the metrics that UN agencies and member states use to evaluate drug policy. With such a commitment, the process will lead the global community to the creation of drug policies that prioritize health, safety, development, and human rights.
Members of the public are invited to join scientists in demanding that drug policies match community needs by adding their names in support of the open letter. They can also voice their top concerns when it comes to drug policy by filling out the online poll.
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