Following positive results in the first Phase 3 study of its investigational medicine Epidiolex, shares in GW Pharmaceuticals skyrocketed more than 120 percent Monday.
In a keenly anticipated clinical trial, the experimental cannabis-based drug has successfully treated children with a rare form of severe epilepsy. This has left the company value more than double the value.
"The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families," Justin Gover, CEO of GW Pharmaceuticals, said in a statement.
With results expected this year, that the drugmaker hopes will confirm the therapeutic benefits of cannabinoids, the active ingredients found in marijuana, the study of GW's Epidiolex in Dravet syndrome is the first of four final-stage Phase III epilepsy trials.
Patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39 percent compared with a reduction on placebo of 13 percent, the 120-patient trial showed according to announcement by GW.
Optimism about the drug's future sales sent shares in GW up 125 percent as the difference was highly statistically significant.
"This shows that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications, hopefully in a range of conditions," Chief Executive Justin Gover told Reuters.
GW would now request a meeting with the U.S. Food and Drug Administration (FDA) to discuss its plans to seek regulatory approval for treating this particular form of epilepsy in light of the positive data, Gover said.
There are currently no FDA-approved therapies for Dravet syndrome.
With a late-stage study in a third epilepsy indication, tuberous sclerosis complex, is due to start soon, results are due this year for a test of Epidiolex, which is given as a child-friendly syrup, is also being tested in Phase III trials for another rare type of epilepsy called Lennox-Gastaut syndrome.
Analysts, on average, believe the drug could generate annual sales of $1.1 billion by 2021, according to consensus forecasts compiled by Thomson Reuters Cortellis.
While purifying the active ingredients so as to avoid psychoactive effects, GW, founded in 1998, aims to capitalize on the medical benefits of cannabis.
There is already regulatory approval in more than 20 countries apart from the United States, for its multiple sclerosis treatment Sativex, which is sprayed under the tongue and is distributed by marketing partners.
Since GW retains full control of the product, Epidiolex is commercially far more significant and the company has also geared the medicine's development to the big U.S. marketplace.
While the Phase III program is the make-or-break hurdle, hopes for the new drug have been building following positive feedback from "compassionate access" programs involving hundreds of American children.
Gover said the success of the first Phase III trial signaled that the access programs had painted an accurate picture of the drug's efficacy.
"It clearly provides us with an excellent basis to be confident about the outcome of the additional trials because this trial has shown that the previous open-label data was very predictive," he said.
(Source:www.cnbc.com)
In a keenly anticipated clinical trial, the experimental cannabis-based drug has successfully treated children with a rare form of severe epilepsy. This has left the company value more than double the value.
"The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families," Justin Gover, CEO of GW Pharmaceuticals, said in a statement.
With results expected this year, that the drugmaker hopes will confirm the therapeutic benefits of cannabinoids, the active ingredients found in marijuana, the study of GW's Epidiolex in Dravet syndrome is the first of four final-stage Phase III epilepsy trials.
Patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39 percent compared with a reduction on placebo of 13 percent, the 120-patient trial showed according to announcement by GW.
Optimism about the drug's future sales sent shares in GW up 125 percent as the difference was highly statistically significant.
"This shows that cannabinoids can produce compelling and clinical important data and represent a highly promising new class of medications, hopefully in a range of conditions," Chief Executive Justin Gover told Reuters.
GW would now request a meeting with the U.S. Food and Drug Administration (FDA) to discuss its plans to seek regulatory approval for treating this particular form of epilepsy in light of the positive data, Gover said.
There are currently no FDA-approved therapies for Dravet syndrome.
With a late-stage study in a third epilepsy indication, tuberous sclerosis complex, is due to start soon, results are due this year for a test of Epidiolex, which is given as a child-friendly syrup, is also being tested in Phase III trials for another rare type of epilepsy called Lennox-Gastaut syndrome.
Analysts, on average, believe the drug could generate annual sales of $1.1 billion by 2021, according to consensus forecasts compiled by Thomson Reuters Cortellis.
While purifying the active ingredients so as to avoid psychoactive effects, GW, founded in 1998, aims to capitalize on the medical benefits of cannabis.
There is already regulatory approval in more than 20 countries apart from the United States, for its multiple sclerosis treatment Sativex, which is sprayed under the tongue and is distributed by marketing partners.
Since GW retains full control of the product, Epidiolex is commercially far more significant and the company has also geared the medicine's development to the big U.S. marketplace.
While the Phase III program is the make-or-break hurdle, hopes for the new drug have been building following positive feedback from "compassionate access" programs involving hundreds of American children.
Gover said the success of the first Phase III trial signaled that the access programs had painted an accurate picture of the drug's efficacy.
"It clearly provides us with an excellent basis to be confident about the outcome of the additional trials because this trial has shown that the previous open-label data was very predictive," he said.
(Source:www.cnbc.com)
