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GW Pharmaceuticals The shares (GWPH) jumped early Wednesday after the launch of cannabinoid oil Epidiolex in the treatment of seizures.
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At the start of trading on the current stock market, GW Pharma shares jumped by 12.5%, nearly 172%, in volume above average. Tuesday late Tuesday, GW announced that its first-quarter sales with Epidiolex had been approved by US seizure treatment last year.
"Everything we heard (at the quarterly teleconference) confirmed our positive thesis on the name," said Marc Goodman, an analyst at Leerink, in a report to his clients. "Overall, we believe that GW was able to add color to the launch, which should reassure investors."
Starting the data entry process
Epidiolex was approved by the Food and Drug Administration in June to treat two types of epilepsy. Epidiolex is made from cannabinoid oil, or CBD oil. The CBD oil in Epidiolex comes from the cannabis plant. This is the first drug of this type to get FDA approval.
Epidiolex launched in November "a strong reputation and a strong demand," said GW Pharma in a press release for its quarter ended December 31. From November 1 to December 31, Epidiolex generated a business turnover of $ 4.7 million. Crisis treatment was prescribed to approximately 4,500 new patients in the first two months.
In addition, more than 500 physicians generated prescriptions issued during this two-month period. In January, the number of prescriptions filled increased by 150% compared to December. Today, GW Pharma has approximately 130 distribution centers for the treatment of CBD oil seizures.
About 900 patients are currently receiving Epidiolex via expanded access programs or open-label extension studies. At the end of the second quarter, GW Pharma expects them to start paying for the CBD oil-based medicine.
It is important to note that more than 80% of patients, approximately 145 million, now have insurance coverage for the treatment of seizures. Six out of ten patients do not require prior authorization to obtain a prescription.
Refills A question for the drug based on CBD oil
Initially, it took four to four and a half weeks for pharmacies to renew CBD oil prescriptions, Leerink said. Now, GW says it's halved by adding distribution centers and increasing insurance coverage.
Most doctors start with small doses of 5 milligrams of the CBD oil-based medicine and slowly increase the prescription to 10 milligrams. Finally, some patients may receive 20 milligram doses of antiepileptic treatment, he said.
"GW thinks most December sales come from" lighter "prescriptions and that this could happen later, as patients move from titration to a maintenance dose," he said. -he declares.
What is the next step for Epidiolex, cannabis drugs?
GW Pharma is now pushing for Epidiolex's approval in Europe – which it expects in the second quarter. He is also studying another cannabis drug, Sativex, in patients with muscular spasticity due to multiple sclerosis. This phase 3 test is expected to begin in the fourth quarter of 2019.
"We believe that GW generally seems on track for the catalysts expected this year," said Goodman, an analyst at Leerink.
GW Pharma is also studying Epidiolex in the tuberous sclerosis complex. In this disorder, patients develop non-cancerous tumors. Epidiolex also tests mid-term Rett syndrome, a rare neurological disorder that affects the child's ability to speak, walk, eat and breathe.
Another cannabis drug is used for screening for autism spectrum disorders and epilepsy.
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