Shire plc has announced the unaudited results for the three months ended March 31, 2017. Flemming Ornskov, Shire CEO, commented:
“In the first quarter we delivered strong top-line growth. (…) Our priorities for the rest of 2017 remain unchanged: launching new products while driving commercial excellence, generating operational efficiencies, and advancing our pipeline of novel therapies. Additionally, we continue to prioritize paying down debt, and we are on track to achieve our full-year financial guidance. Looking ahead, I see tremendous opportunity for further growth as we continue to build on our position as the global leader in treating patients with rare diseases.”
From the Product and Pipeline Highlights:
- Increased CINRYZE sales by 38% to $226 million, reflecting higher patient demand and improvements in available supply.
- On March 16, 2017, the EC approved a label extension for Cinryze (C1 inhibitor [human]), broadening its use to children with HAE. Cinryze is now the first and only treatment indicated for routine prevention of angioedema attacks in children aged six years or older who have severe and recurrent attacks of HAE and cannot tolerate or are not adequately protected by oral preventative treatments, or who are inadequately managed with repeated acute treatment. Cinryze is also now approved for acute treatment and pre-procedure prevention of angioedema attacks in children aged two years or older with HAE.
- The SHP643 open-label extension study completed enrollment in March 2017. Topline pivotal Phase 3 study results are expected in Q2 2017.