Merck's Keytruda wins first checkpoint inhibitor lung cancer approval in China; Puma sells rights to Nerlynx in Europe, parts of Africa for $60M upfront
→ Merck’s entrenched flagship Keytruda immunotherapy has just scored a key lung cancer approval in China. The drug, already sanctioned for use in advanced melanoma in the geography since last July, has now won the nod for metastatic nonsquamous NSCLC, marking the first anti-PD-1 therapy approved for more than one tumor type in China. Altogether, Keytruda is now approved in combination with chemotherapy for this patient population in the US, Europe, Japan and China, among other countries. The blockbuster checkpoint inhibitor generated about $7.2 billion in sales last year for Merck $MRK.
→ After successfully lobbying European regulators to have a change of heart and approve its breast cancer drug Nerlynx last year, Puma Biotechnology $PBYI is palming off the treatment to Pierre Fabre. Under the deal, Puma will receive an upfront payment of $60 million, is eligible for milestone payments totaling up to $345 million, as well as significant double-digit royalties on sales in territories exclusively licensed by Pierre Fabre. Pierre Fabre will sell the drug in European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa, and will be tasked with conducting additional clinical studies and leading regulatory activities in connection with the EMA. “While the terms of the deal for this region appear reasonable, we believe some investors may be disappointed with an additional licensing agreement that could further reduce the strategic value of Nerlynx to a potential acquirer,” SVB Leerink analysts wrote, noting that Pierre Fabre is now Puma’s sixth marketing partner, with the United States and Japan as the only remaining unencumbered major markets.
→ Embattled MannKind Corp $MNKD is reaping the benefits of its 2018 partnership with United Therapeutics $UHTR. On Monday, the company said a developmental milestone associated with the development of a dry powder formulation of the pulmonary arterial hypertension drug treprostinil has triggered the payment of $12.5 million. Under the deal, MannKind is eligible to earn an additional $37.5 million upon the achievement of other milestones, as well as low double-digit royalties on net sales of the treatment, if approved.