Summary
Gilead is seeking approval for Hepatitis C Genotypes 1-6.
Approval would help to expand patient population eligible for Gilead products.
Gilead's last two Hepatitis C treatments have been blockbusters.
While the world pays attention to Brexit, investors in pharmaceutical stocks will be watching the FDA for decisions on PDUFA dates. One big decision that is expected out this week, has the potential to substantially expand Gilead Sciences (NASDAQ:GILD) pipeline of treatments for HCV. This treatment has the potential to be very important for Gilead Investors and has the potential to help revolutionize the way that we treat HCV in the United States.
Gilead's Existing HCV Pipeline
Gilead is very well known for its pipeline of drugs for Hepatitis C Virus. It has two of the best selling HCV drugs, Harvoni and Sovaldi brought in a combined $4.29 billion last quarter. Both of these drugs have been controversial for their high price tag, and have even been the subject of patent litigation between Merck (NYSE:MRK), Ionis Pharmaceuticals (NASDAQ:IONS) and Gilead, which Gilead recently won. Clearly, protecting its dominance in the HCV space is important for Gilead's long term vision for the company.
Gilead's New HCV Treatment
Gilead is seeking approval for a combination of Sovaldi, and investigational drug Velpatasvir in Hepatitis C genotypes one through six. The drug has a PDUFA date of June 28, 2016. One of the biggest problems with Harvoni and Sovaldi are that the drugs are indicated for only certain genotypes of Hepatitis C. Patients with genotypes outside of the ones that Harvoni and Sovaldi are approved for, are not eligible for the drug. Hepatitis C has six genotypes. Numbers one through four are eligible for use with Harvoni and Sovaldi. While genotypes five and six are rare within North America, most of the treatment options that exist for Hepatitis C do not cover genotypes five and six. Having a treatment that has the potential to cover all six genotypes of Hepatitis C could be a game changer for doctors. Should the pill be approved, it would make it easier for doctors to start treatment without having to test patients for their genotype of Hepatitis C. One of the biggest differentiators in Harvoni vs. Sovaldi is that Harvoni is not approved for Genotype 2 and is only approved for some types of Genotype three. While Sovaldi covers the gaps for genotypes 1-4, it still would be easier for doctors if they did not have to test genotypes and instead could move straight into treatment options with a relative degree of certainty. This could also help to give Gilead a leg up in the market.
Gilead is seeking approval for Hepatitis C Genotypes 1-6.
Approval would help to expand patient population eligible for Gilead products.
Gilead's last two Hepatitis C treatments have been blockbusters.
While the world pays attention to Brexit, investors in pharmaceutical stocks will be watching the FDA for decisions on PDUFA dates. One big decision that is expected out this week, has the potential to substantially expand Gilead Sciences (NASDAQ:GILD) pipeline of treatments for HCV. This treatment has the potential to be very important for Gilead Investors and has the potential to help revolutionize the way that we treat HCV in the United States.
Gilead's Existing HCV Pipeline
Gilead is very well known for its pipeline of drugs for Hepatitis C Virus. It has two of the best selling HCV drugs, Harvoni and Sovaldi brought in a combined $4.29 billion last quarter. Both of these drugs have been controversial for their high price tag, and have even been the subject of patent litigation between Merck (NYSE:MRK), Ionis Pharmaceuticals (NASDAQ:IONS) and Gilead, which Gilead recently won. Clearly, protecting its dominance in the HCV space is important for Gilead's long term vision for the company.
Gilead's New HCV Treatment
Gilead is seeking approval for a combination of Sovaldi, and investigational drug Velpatasvir in Hepatitis C genotypes one through six. The drug has a PDUFA date of June 28, 2016. One of the biggest problems with Harvoni and Sovaldi are that the drugs are indicated for only certain genotypes of Hepatitis C. Patients with genotypes outside of the ones that Harvoni and Sovaldi are approved for, are not eligible for the drug. Hepatitis C has six genotypes. Numbers one through four are eligible for use with Harvoni and Sovaldi. While genotypes five and six are rare within North America, most of the treatment options that exist for Hepatitis C do not cover genotypes five and six. Having a treatment that has the potential to cover all six genotypes of Hepatitis C could be a game changer for doctors. Should the pill be approved, it would make it easier for doctors to start treatment without having to test patients for their genotype of Hepatitis C. One of the biggest differentiators in Harvoni vs. Sovaldi is that Harvoni is not approved for Genotype 2 and is only approved for some types of Genotype three. While Sovaldi covers the gaps for genotypes 1-4, it still would be easier for doctors if they did not have to test genotypes and instead could move straight into treatment options with a relative degree of certainty. This could also help to give Gilead a leg up in the market.
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