Shire plc (SHPG - Free Report) announced that the European Commission (EC) has granted marketing approval to Takhzyro (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Takhzyro is the first monoclonal antibody to get approval for the preventive treatment of HAE in patients aged 12 years and older in the European Union. The recommended starting dose is 300 mg lanadelumab every two weeks.
HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.
Notably, Takhzyro received approval for the same indication in the United States in August 2018 and in Canada in September 2018.
The European approval was supported by data from a phase III HELP study, which showed that patients taking Takhzyro 300 mg every two weeks had an 87% reduction in mean monthly HAE attacks versus placebo, while the patients taking Takhzyro 300 mg every four weeks had 73% reduction in attacks.
A pre-specified, exploratory analysis showed that 44% of the patients (n=27) receiving Takhzyro 300 mg every two weeks had zero attacks compared to placebo for the 26-week treatment period. Further, a post hoc analysis of the 16-week period from day 70 to day 182 showed that 77% of patients (n=26) treated with Takhzyro in the same dosage arm of the study were attack-free compared to placebo.
Shares of Shire have increased 14.1% year to date against the industry’s decline of 7.3%.
We remind investors that Takhzyro was added to Shire’s HAE portfolio with the acquisition of Dyax Corp., which was completed in January 2016. Moreover, the acquisition added another candidate, Kalbitor to the company’s portfolio, which is under review in Europe and also being developed for HAE. Shire already has Cinryze in its portfolio for the treatment of HAE. Cinryze is the first C1 esterase inhibitor (C1-INH) approved by the FDA to help prevent swelling attacks in children (six years of age and older), teenagers and adults.
Shire has agreed to be acquired by Japan-based Takeda Pharmaceutical, valuing the offer at 47 pounds per share or around 46 billion pounds ($62 billion). The acquisition is expected to close in the first half of 2019.
Shire plc Price
Zacks Rank & Stocks to Consider
Shire is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks worth considering are Bristol-Myers Squibb Company (BMY - Free Report) , Gilead Sciences Inc. (GILD - Free Report) and Merck & Co. (MRK - Free Report) . While Bristol-Myers and Gilead sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.63 to $3.87 for 2018 and $3.92 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.
Gilead’s earnings per share estimates have increased from $6.60 to $6.93 for 2018 and $6.53 to $6.83 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 6.99%.
Merck’s earnings per share estimates have increased from $4.28 to $4.34 for 2018 and $4.67 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 3.96%. Shares of the company have increased 44.3% year to date.
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