Jazz Phar­ma­ceu­ti­cals’ $1 bil­lion bet last year looks to be pay­ing off so far: for them and their part­ner.

Sev­en months af­ter the Irish bio­phar­ma li­censed Phar­ma­Mar’s small cell lung can­cer drug lur­binecte­din, the FDA has grant­ed it ac­cel­er­at­ed ap­proval. The drug, which was sub­mit­ted two days be­fore Jazz signed on in De­cem­ber and lat­er grant­ed pri­or­i­ty re­view, will be mar­ket­ed as Zepzel­ca.

Zepzel­ca won’t en­ter the mar­ket un­til Ju­ly, at which point Jazz will face the dif­fi­cult hur­dles of com­mer­cial­iz­ing a drug in a pan­dem­ic, but the ap­proval should trig­ger an im­me­di­ate pay­off for Phar­ma­Mar. Al­though the ex­act terms aren’t spelled out, the orig­i­nal li­cens­ing agree­ment in­clud­ed “up to $250 mil­lion up­on the achieve­ment of ac­cel­er­at­ed and/or full reg­u­la­to­ry ap­proval of lur­binecte­din by FDA with­in cer­tain time­lines.” That deal al­so in­clud­ed $200 mil­lion up­front and $550 mil­lion in com­mer­cial mile­stones.

It’s a bit of re­demp­tion for the Span­ish bio­phar­ma. Orig­i­nal­ly found­ed in 1986 and lat­er re­spon­si­ble for the sar­co­ma drug Yon­delis, Phar­ma­Mar’s stock crashed in 2018 af­ter Zepzel­ca failed in a late-stage ovar­i­an can­cer study.

Still, that left a pair of tri­als on small cell lung can­cer. And at AS­CO in 2019, Phar­ma­Mar an­nounced the Phase II study had shown a 35.2% over­all re­sponse rate as a sec­ond-line ther­a­py — and 45% for the co­hort they de­ter­mined most sen­si­tive to treat­ment. Those pa­tients saw a pro­gres­sion-free sur­vival of 4.6 months and an over­all sur­vival of 11.9 months.

That may not trans­late in­to ac­cel­er­at­ed ap­proval for every in­di­ca­tion, but small cell lung can­cer has for years been a dif­fi­cult field for drug de­vel­op­ment. Be­fore 2018, when Bris­tol My­ers Squibb’s im­munother­a­py Op­di­vo was ap­proved for third-line pa­tients, no drug had been ap­proved for the tu­mor type in over a decade, ac­cord­ing to the Lung Can­cer Re­search Foun­da­tion. Since then, Keytru­da won ap­proval as a third-line treat­ment, and Tecen­triq and Imfinzi were cleared as a first-line ther­a­pies.

This is Jazz’s sec­ond ap­proval in a lit­tle over a year, af­ter their fol­low-on nar­colep­sy drug Sunosi was OK’ed last March. It is their third can­cer ap­proval. Ac­cel­er­at­ed ap­provals can be con­tin­gent on a con­fir­ma­to­ry tri­al, and a Phase III study is al­ready un­der­way.

The US House of Representatives is taking a further interest in domestic pharma manufacturing by creating the Domestic Pharmaceutical Manufacturing Caucus, led by Reps. Buddy Carter (R-GA), Elissa Slotkin (D-MI), Gus Bilirakis (R-FL) and Chrissy Houlahan (D-PA).

As the supply chain increasingly is outsourced to China and India, particularly on the active pharmaceutical ingredient side, the caucus will aim to focus on moving forward legislation that incentivizes greater domestic manufacturing of medicines. Carter said the caucus will try to reduce US reliance on “foreign adversaries,” try to ensure an adeqate supply of pharmaceuticals and try to halt supply chain disruptions.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.