On Nov. 26, GW’s frontline cannabinoid drug Epidiolex posted positive results in the second Phase-3 trial for treating patients diagnosed with the Dravet syndrome, a rare form of epilepsy which causes seizures right from childhood. It is estimated that there are 2.2 million people in the US are suffering from epilepsy and nearly 470,000 are children.
Also read: GW Pharmaceuticals Q4 2018 earnings conference call transcript
Epidiolex sales for Nov 1 – Dec 31 launch period stood at $4.7 million. In the first two month selling period, approximately 4,500 new patients enrolled and over 500 physicians have generated dispensed prescriptions. Open label extension patients are expected to migrate to the commercial product by the end of Q2 2019.
Epidiolex was approved by the US FDA in June 2018 to treat patients suffering from seizures relating to Dravet syndrome or Lennox-Gastaut syndrome (LGS). GW Pharma filed a marketing authorization application with the European Medicines Agency (EMA) and CHMP recommendation is expected in Q2 2019.
“We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year,” said CEO Justin Gover.
Earlier today, GW’s peer Zynerba Pharmaceuticals (ZYNE) soared about 15% in the pre-market trading hours as it won the patent for its CBD gel which is used to treat Fragile X syndrome. However, Zynbera stock lost the early momentum during today’s regular trading session.
GW stock, which plunged to a 52-week low ($90.14) during December end, had surged 57% since the beginning of 2019.
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