Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

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.

“Boehringer In­gel­heim aims to seize the op­por­tu­ni­ty to be­come the pre­ferred part­ner in the in­no­va­tion ecosys­tem in Chi­na’s bio­phar­ma in­dus­try,” Weiyi Zhang, head of the in­no­va­tion hub, told Shang­hai Dai­ly.

The new unit will serve as an um­brel­la for cer­tain ex­ist­ing di­vi­sions such as col­lab­o­ra­tions, busi­ness de­vel­op­ment and li­cens­ing, as well as ven­ture ac­tiv­i­ties, the pa­per not­ed.

As reg­u­la­to­ry re­forms light­en the bur­den for for­eign drug­mak­ers to score ap­provals in Chi­na, Boehringer has be­gun to in­cor­po­rate Chi­nese sites in all its glob­al ear­ly-stage pro­grams. At the same time, the flour­ish­ing lo­cal biotech scene al­so makes for fer­tile soil to nur­ture new dis­cov­er­ies and fos­ter de­vel­op­ment.

Boehringer was one of the first con­tract man­u­fac­tur­ers to sign up for a pi­lot scheme when Chi­nese reg­u­la­tors loos­ened their rules to stop de­mand­ing that a drug’s own­er al­so pro­duce it. In the be­gin­ning of this year, it made his­to­ry when BeiGene land­ed an OK for its PD-1 tislelizum­ab, putting Boehringer’s Shang­hai fa­cil­i­ty to use.

Just weeks ago Boehringer un­veiled a €3 mil­lion plan to open a branch of its dig­i­tal lab, BI X, in Shang­hai — the first out­side Ger­many and on­ly the sec­ond in the world.

The team of 20 there will ded­i­cate them­selves to un­der­stand­ing the par­tic­u­lar needs of Chi­nese pa­tients and cus­tomers, whom they say have “high dig­i­tal ca­pa­bil­i­ties.”

“The COVID-19 sit­u­a­tion has high­light­ed the im­por­tance of dig­i­tal ser­vices, and our lat­est dig­i­tal ini­tia­tive hopes to in­te­grate all the method­ol­o­gy and tech­nol­o­gy with re­al busi­ness needs,” Gutsche said in an in­ter­view with Shang­hai Dai­ly. “Chi­na is the first mar­ket to see busi­ness re­bound af­ter the coro­n­avirus out­break, and we’ve seen im­prove­ment in the sec­ond-quar­ter busi­ness per­for­mance.”

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Shortly after Sirnaomics brought in a $47 million Series C for its small interfering RNA pipeline last year, Patrick Lu — the founder, president and CEO — was asked to outline the scientific advances that will be necessary to make better drugs out of RNA tech.

“The next step in the evolution of RNAi as a leading therapeutic will be the ability to safely target organs outside the liver such as lung, brain, etc,” he had offered. “This will revolutionize disease treatments if the industry can demonstrate similar data sets for non-liver targets as we have seen in liver-based diseases.”

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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