Correvio exploring possible sale in wake of FDA panel setback over atrial fibrillation drug Brinavess

Correvio Pharma said Wednesday that it is considering various strategic alternatives, including a potential sale of the company or its assets, sending shares down as much as 65%. The announcement comes a day after an FDA advisory panel voted against recommending approval for its anti-arrhythmic drug Brinavess (vernakalant) to treat recent onset atrial fibrillation in adults, citing several safety concerns.

CEO Mark Corrigan said Correvio has a "strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the FDA's decision regarding Brinavess," expected by December 24. "We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the board of directors," he added.

In addition to cutting back on operating expenditures in North America, Correvio says it will concentrate resources on "only essential commercial and business development activities." The company, which did not specify whether its cost reduction measures would involve job cuts, had nearly 138 employees across Europe, the US and Canada as of the end of last year, according to its annual filing. Meanwhile, it also said  it hasn't set a timetable to complete the review process, and there is no guarantee any transaction will ultimately result.

In regards to its commercial portfolio outside the US, Correvio said it is on track to deliver more than $30 million in revenue in 2019. Aside from Brinavess, which is already approved in Europe and other markets, Correvio's portfolio consists of Xydalba (dalbavancin), which is prescribed to treat acute bacterial skin and skin structure infections, the antibiotic Zevtera/Mabelio (ceftobiprole medocaril) for community- and hospital-acquired pneumonia, and the antiplatelet drug Aggrastat (tirofiban) to reduce thrombotic cardiovascular events in patients with acute coronary syndrome.

The company also plans to file Trevyent (treprostinil) with European regulators in mid-2020. Correvio holds commercial rights to Trevyent, used to treat pulmonary arterial hypertension (PAH), in Europe as well as the Middle East, while United Therapeutics recently filed an application seeking approval of the drug-device combination with the FDA for PAH.  

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