Up­dat­ed: Lon­za sets sights on ex­pan­sion, buy­ing No­var­tis fa­cil­i­ty; IQVIA leads $14 mil­lion Se­ries B fund­ing round

Lon­za Phar­ma & Biotech is ex­pand­ing, buy­ing up a Swiss fa­cil­i­ty No­var­tis has been us­ing to pro­duce drug vials and plug­ging it in­to their glob­al sup­ply net­work for in­dus­try clients. As is of­ten the case with these deals, Lon­za is pick­ing up the work for No­var­tis un­der con­tract. The fa­cil­i­ty has been up and run­ning for a decade now, serv­ing as the No­var­tis Cen­ter of Ex­cel­lence for ster­ile clin­i­cal (Phas­es I to III) drug prod­uct man­u­fac­tur­ing. Lon­za has al­ready an­nounced ex­pan­sions at its sites in Basel and Visp, Switzer­land and “from 2020 the group will ex­pand de­vel­op­ment and test­ing labs in­to a larg­er build­ing in Basel and ex­pects its Ibex So­lu­tions fill and fin­ish fa­cil­i­ty in Visp to be op­er­a­tional on-track from mid-2021.”

CNS Phar­ma — which raised some eye­brows ear­li­er this year with its un­con­ven­tion­al dri­ve to crowd­fund first-in-hu­man stud­ies of a glioblas­toma drug — has fol­lowed up with a mi­ni IPO. With a goal of $10 mil­lion (a price range of $4 to $5 for 2.1 mil­lion shares), the pub­lic de­but would amount to a small frac­tion of what we’ve seen in re­cent biotech IPOs but help the tiny play­er test the ef­fi­ca­cy of its chemother­a­py agent. The drug, beru­bicin, be­longs to a well-known class of drugs known as an­thra­cy­cline but ap­pears able to cross the blood-brain bar­ri­er and thus tar­get no­to­ri­ous­ly tough brain can­cer cells. Hous­ton-based CNS Phar­ma in-li­censed it from Rea­ta Phar­ma, which con­duct­ed a Phase I study sug­gest­ing a 44% re­sponse rate be­fore shelv­ing the pro­gram.

Am­i­cus Ther­a­peu­tics has lined up a sup­ply deal for its gene ther­a­py work with the CD­MO Ther­mo Fish­er. Am­i­cus al­so set up a plas­mid sup­ply net­work. 

Be­long.Life — a US-Is­raeli cre­ator of the mo­bile so­cial net­work­ing app Be­long – Beat­ing Can­cer To­geth­er for can­cer care­givers, health­care pro­fes­sion­als and pa­tients to man­age their treat­ment jour­ney — has raised $14 mil­lion in a Se­ries B fund­ing round led by IQVIA. The round al­so in­clud­ed The Group Ven­tures and ex­ist­ing in­vestors. The com­pa­ny plans to use the fund­ing to ad­vance and ex­pand its can­cer net­work­ing app and its new Be­long Pa­tient En­gage­ment Plat­form (PEP), which is de­signed to im­prove pa­tient en­gage­ment, ed­u­ca­tion, com­pli­ance, sat­is­fac­tion, au­to-care co­or­di­na­tion and ef­fi­cien­cy. Be­long.Life was found­ed in 2015 by Eli­ran Mal­ki, Irad Deutsch and Ohad Ru­bin af­ter each lost rel­a­tives to can­cer. The com­pa­ny has part­ner­ships with the Amer­i­can Can­cer So­ci­ety, GO2 Foun­da­tion for Lung Can­cer, Col­orec­tal Can­cer Cana­da and oth­ers. 

PTC Ther­a­peu­tics $PTCT and Odylia Ther­a­peu­tics inked a col­lab­o­ra­tion to de­vel­op gene ther­a­pies for rare in­her­it­ed reti­nal dis­eases us­ing the Anc80 vec­tor sys­tem de­vel­oped by re­searchers at Mass­a­chu­setts Eye and Ear.


Ear­li­er ver­sion didn’t in­clude CNS Phar­ma’s IPO

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.

New trade deal knocks out long-sought patent pro­tec­tions for drug­mak­ers

House Democrats negotiating with the Trump Administration on a new North American trade deal settled early on four issues: enforcement, labor and environmental standards and drug pricing.

On drug pricing, Politico reports, Trump crumbled within weeks of heightened negotiations.

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