Sean Bo­hen, As­traZeneca

As­traZeneca ap­pears ready to start broad­en­ing the mar­ket for its PARP in­hibitor Lyn­parza. AS­CO or­ga­niz­ers picked the phar­ma gi­ant’s Phase III da­ta for HER-2 neg­a­tive metasta­t­ic breast can­cer for the Sun­day spot­light. And it’s not hard to see why.

The drug was linked with tu­mor shrink­age in 60% of the pa­tients with germline BR­CA1 or BR­CA2 mu­ta­tions tak­ing the drug, com­pared to 29% in the chemo group.

An­a­lyz­ing the lat­est da­ta on Lyn­parza, in­ves­ti­ga­tors found a 42% re­duc­tion in the risk of dis­ease pro­gres­sion or death.

The top line suc­cess was an­nounced back in Feb­ru­ary.

The da­ta give As­traZeneca $AZN a chance to get an ear­ly start over Clo­vis’ Rubra­ca and Tesaro’s Ze­ju­la in mov­ing be­yond the ovar­i­an can­cer mar­ket. The re­sults al­so un­der­score the phar­ma gi­ant’s grow­ing suc­cess in the can­cer field — cru­cial to its longterm turn­around plans — with the ap­proval of their PD-L1 drug Imfinzi (dur­val­um­ab) re­cent­ly and loom­ing re­sults for a com­bi­na­tion of that check­point with treme­li­mum­ab, a CT­LA-4 ther­a­py.

Notes As­traZeneca CMO Sean Bo­hen:

“The OlympiAD re­sults shared to­day mark the first time a tar­get­ed ther­a­py shows ben­e­fit over the cur­rent stan­dard of care for pa­tients with HER2-neg­a­tive gBR­CA-mu­tat­ed metasta­t­ic breast can­cer. This al­so rep­re­sents an im­por­tant mile­stone for Lyn­parza as this is the first pos­i­tive Phase III tri­al in which a PARP in­hibitor has shown a sig­nif­i­cant ben­e­fit for pa­tients out­side of ovar­i­an can­cer.”

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.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.