Christophe We­ber, Take­da CEO

Take­da is get­ting a big bonus from the FDA to­day for its $5.2 bil­lion buy­out of Ari­ad. The phar­ma com­pa­ny ac­quired the late-stage can­cer drug briga­tinib in the ac­qui­si­tion back in Jan­u­ary, and now the FDA has ap­proved it for ALK-pos­i­tive cas­es of non-small cell lung can­cer.

Take­da can now set out to re­al­ize its pro­jec­tions of $1 bil­lion-plus in an­nu­al sales for briga­tinib — which will be mar­ket­ed as Alun­brig — which are sig­nif­i­cant­ly more ag­gres­sive than most an­a­lysts, who have been pre­dict­ing $500 mil­lion to $800 mil­lion in sales.

An­drew Plump, Take­da CSO

As is com­mon these days, the FDA arranged a quick OK based on the lat­est study of two dos­es of the drug, al­so tagged as a break­through ther­a­py, with­out a com­par­i­son arm. It is ap­proved for pa­tients who have failed on Pfiz­er’s Xalko­ri.

They key to its longterm suc­cess, though, like­ly lies in an on­go­ing Phase III study of the drug in first-line pa­tients, dubbed AL­TA 1L, in a head-to-head against Xalko­ri. That study launched a year ago.

In ear­ly De­cem­ber Ari­ad re­port­ed that at a fol­low-up of 11-months, the drug demon­strat­ed a pro­gres­sion-free sur­vival rate of 15.6 months with a 55% con­firmed ob­jec­tive re­sponse rate for non-small cell lung can­cer pa­tients tak­ing the 180 mg dose briga­tinib.

The suc­cess to­day marks a big plus for Take­da CEO Christophe We­ber, who raised eye­brows for pay­ing a sig­nif­i­cant pre­mi­um for Ari­ad, which al­so net­ted the mar­ket­ed drug Iclusig. We­ber and R&D chief Andy Plump have been rip­ping up the old R&D struc­ture over the past year. And they cut 180 of the 300 Ari­ad staffers in the last two months — though some may have wound up with jobs at PRA.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.