Oct. 21 Company Quick Takes: Vertex's triplet gains FDA approval; plus Bavarian Nordic-GSK, Farxiga, Ultomiris, Stelara

FDA approves Vertex's triplet for CF
Vertex Pharmaceuticals Inc. priced triple combination cystic fibrosis therapy Trikafta elexacaftor/ivacaftor/tezacaftor at an annual wholesale acquisition cost of $311,503 after FDA approved the drug on Monday, almost five months ahead of its PDUFA date. The agency approved Trikafta to treat cystic fibrosis patients aged 12 and older who have at least one ΔF508 mutation in the CF transmembrane conductance regulator (CFTR) gene. The agency said that group represents about 90% of the CF population, or about 27,000 U.S. patients. Vertex will receive a rare pediatric disease Priority Review voucher as a result of the approval. FDA said it completed the review in three months, well ahead of the March 19, 2020, goal date. Vertex bumped up its 2019 guidance to $3.70-$3.75 billion from $3.6-$3.7 billion (see "Why Vertex Picked Elexacaftor for Triple Regimen").

Bavarian Nordic acquires GSK vaccines
Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) gained global rights to RabAvert and Encepur from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). GSK will receive €301 million ($336 million) up front, about €159 million for existing inventory and up to €495 million in milestone payments. The deal for the rabies and encephalitis vaccines, which GSK gained in a 2015 asset swap with Novartis AG (NYSE:NVS; SIX:NOVN), comes a month after FDA approval of Bavarian Nordic’s smallpox and monkeypox vaccine Jynneos MVA-BN...