Jazz's (JAZZ) Epidyolex Gets Approval for New Indication in UK
Jazz's (JAZZ) unit GW Pharmaceuticals' Epidyolex (cannabidiol) gets a regulatory nod for a new indication in the United Kingdom. Following this announ...
Jazz JAZZ announced that GW Pharmaceuticals, its newly acquired subsidiary, received an approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for an expanded use of Epidyolex (cannabidiol) to treat tuberous sclerosis complex (TCS) associated seizures.
Following its label expansion in the UK, Epidyolex is eligible to treat seizures in three forms of epilepsy. In September 2019, the drug was granted a marketing authorization (MAA) in the country as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) and Dravet syndrome.
The authorization for TSC makes it the fourth approved indication for a cannabis-based medicine in the UK for GW Pharmaceuticals. Apart from Epidyolex, GW has the marketable drug Sativex (nabiximols) in its pipeline. It is a cannabis-based mouth spray for multiple sclerosis (MS)-related spasticity. Sativex is yet to receive an approval in the United States.
Shares of the company fell 4.2% on Aug 10 following the above-mentioned news. In fact, the stock has declined 12.4% so far this year, in line with the industry.
Image Source: Zacks Investment Research
The approval is based on data from a positive phase III safety and efficacy study evaluating cannabidiol. The study met its primary endpoint, which is, reduction in seizure frequency when treated with cannabidiol as compared to placebo. Data from the study exhibited 49% seizure reduction in patients taking cannabidiol as compared to 27% for placebo. All key secondary endpoints were supportive of the effects on the primary endpoint.
TSC is a rare genetic condition that causes most benign tumors to grow in vital body organs and is a leading cause for genetic epilepsy. Typically diagnosed in childhood, the indication has an estimated prevalence between 3,700 and 11,000 people in the UK. Following label expansion, Epidyolex is expected to drive sales for the company.
In the United States, the drug is marketed under the brand name Epidiolex. In August 2020, the same was approved in the country to treat seizures associated with TCS in addition to the treatment of seizures associated with LGS and Dravet syndrome. In April 2021, Epidyolex was approved in the EU for the same indication.
Jazz acquired GW Pharmaceuticals, a British cannabinoid drug company in May, which added a third high-growth commercial franchise to the company’s business.
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the biotech/drug sector are Catalent CTLT, Horizon Therapeutics HZNP and Ironwood Pharmaceuticals IRWD, each of which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Catalent’s stock has risen 14.5% in the year so far.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 43.5% in the year so far.
Ironwood’s earnings per share estimates for 2021 have increased from $1.05 to $2.04 in the past 30 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 18.5% in the year so far.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Ironwood Pharmaceuticals, Inc. (IRWD): Free Stock Analysis Report
Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report
Horizon Therapeutics Public Limited Company (HZNP): Free Stock Analysis Report
Catalent, Inc. (CTLT): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research