We are pleased to announce that we have now completed our Pivotal BE program for Macitentan 10mg film-coated tablets. This product has been developed in collaboration with one of our strategic partners.
Our product has been developed based on the reference brand Opsumit 10mg film-coated Tablets, which is indicated in the treatment of Pulmonary Arterial Hypertension, a highly debilitating orphan disease. The brand sold approximately $1.4bn globally in 2021, having a significant growth potential with Global 3Y CAGR at +17%, according to IQVIA.
We now progress with dossier completion, in the coming weeks, and the CPP for ROW submissions is readily available.
Based on this positive progress, we believe we will be among the first companies to file in Europe, which is expected on day 1, as soon as regulatory exclusivity expires.
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At Adalvo, there are no half measures – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.
ajish.rajan@adalvo.com – Central & Eastern Europe, Russia & CIS
aitor.alferez@adalvo.com – South Europe & Israel
jose.rendueles@adalvo.com- North Europe, APAC and MENA,
margarida.neves@adalvo.com – Brazil
paulo.rodriguez@adalvo.com – LATAM (Exc. Brazil)
supreet.sharma@adalvo.com – UK/Ireland, North America & South Africa
arni.baldursson@adalvo.com - Head of Global BD&L
Disclaimer: Macitentan which is subject to patent protection is currently not offered or made available in countries where patents are in force.