Shire plc SHPG announced that the European Commission (EC) has approved a label extension for drug Cinryze for use in pediatrics.
Consequently, Cinryze is now approved for routine prevention of angioedema attacks in children (aged 6 years and above) with severe and recurrent attacks of hereditary angioedema (HAE) who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatments.
The drug is now approved for the treatment and pre-procedure prevention of angioedema attacks in children (aged 2 years and above) with HAE.
We note that the drug was approved for these indications in adults and adolescents aged 12-17 years with HA since 2011.
Cinryze recorded sales of $680.2 million in 2016, up 10% driven by an increase in the number of patients on therapy which was partially offset by reduced utilization as a result of a supply constraint in the U.S. during the second half of the year.
A label expansion of the drug is likely to boost sales further. Shire acquired ViroPharma in 2014 and added Cinryze to its portfolio. Cinryze complements Shire's Firazyr, which is indicated for the on-demand treatment of acute HAE attacks. The acquisition of Dyax added Kalbitor to Shire's HAE portfolio.
Shire's shares have outperformed the Zacks classified Medical-Drugs industry. The stock gained 5.6% so far in 2017 better than the industry's gain of 5.1%.
We note that Shire has a dominant position in the rare diseases market, which is growing faster than the broader biopharmaceutical market. Strong performance of Vyvanse, Lialda and Firazyr should continue to drive its top line in the upcoming quarters. The approval of Xiidra has boosted the company's ophthalmology space.
Shire PLC Price
Shire PLC Price | Shire PLC Quote
Zacks Rank & Key Picks
Shire currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include Heska Corporation HSKA , Anthera Pharmaceuticals, Inc. ANTH and Retrophin, Inc. RTRX . All the three stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.
Heska's earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%. Its share price increased 34.2% year to date.
Anthera's loss estimates narrowed from $1.49 to $1.17 for 2017 over the last 60 days.
Retrophin's loss estimates narrowed from 85 cents 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
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