The ver­dict is in from Ver­tex’s clin­i­cal team.

The biotech was pre­sent­ed with a pleas­ant dilem­ma in March when a cock­tail for cys­tic fi­bro­sis mix­ing VX-​445, teza­caftor and iva­caftor passed Phase III with fly­ing col­ors, match­ing the re­sults they got for VX-659 with the oth­er two drugs, al­so known as Symdeko and Ka­ly­de­co. That left ob­servers hang­ing as to which com­bo will head to reg­u­la­tors.

Ver­tex ul­ti­mate­ly de­cid­ed to go with VX-445 — af­ter re­view­ing some more da­ta it’s dis­clos­ing to­day.

Resh­ma Ke­wal­ra­mani Ver­tex

At week 24 of treat­ment, pa­tients with one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion on the drug main­tained ab­solute im­prove­ment in per­cent pre­dict­ed forced ex­pi­ra­to­ry vol­ume in one sec­ond of 14.3% (p<0.0001). For a key sec­ondary end­point, the same group of pa­tients saw a 63% re­duc­tion in the an­nu­al­ized rate of pul­monary ex­ac­er­ba­tions com­pared to place­bo, with the same stel­lar p-val­ue.

As pre­vi­ous­ly re­port­ed, pa­tients on the VX-445 triple had their ppFEV1 im­prove by an av­er­age of 13.8% at week 4. In a sep­a­rate tri­al for VX-​659, the num­ber was 14%.

“Peo­ple with CF who have one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion are the largest re­main­ing group of CF pa­tients with­out a treat­ment op­tion for the un­der­ly­ing cause of their dis­ease,” CMO Resh­ma Ke­wal­ra­mani said in a state­ment.

The biotech fur­ther not­ed that the de­ci­sion “was based on a de­tailed as­sess­ment of mul­ti­ple fac­tors, in­clud­ing fa­vor­able pro­files for safe­ty, tol­er­a­bil­i­ty and drug-drug in­ter­ac­tions, the abil­i­ty for co-ad­min­is­tra­tion with hor­mon­al con­tra­cep­tives, and the lack of pho­to­sen­si­tiv­i­ty.”

Ver­tex will now take these da­ta, along­side an­oth­er 4-week Phase III study CF pa­tients with two F508del mu­ta­tions, to the FDA in Q3 and then the EMA in Q4.

Cred­it Su­isse an­a­lysts are ful­ly on board with the plan, say­ing it sig­nals a “clear path for­ward for the triple com­bo, with longer-term da­ta sup­port­ing con­tin­ued ef­fi­ca­cy. We ex­pect ap­proval in 1H20, al­low­ing the co. to treat 90% of CF pts WW. OUS re­im­burse­ment ques­tions re­main.”

Im­age: Ver­tex Phar­ma­ceu­ti­cals

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)