No­var­tis CEO Vas Narasimhan lines up his late-stage block­buster con­tenders — mix­ing old fa­vorites and add-ons

Every Big Phar­ma com­pa­ny is judged by its late-stage pipeline and the num­ber of prospec­tive block­busters in play. No­var­tis CEO Vas Narasimhan is giv­ing his piv­otal strat­e­gy top marks to­day as the gi­ant play­er re­views its de­vel­op­ment game plan in the wake of a cou­ple of key set­backs.

Adding it all up, No­var­tis is us­ing its R&D re­view to high­light a tal­ly of 26 block­busters in the pipeline, 13 projects in what is now grouped in­to cell, gene and ra­di­oli­gand work — adding ra­dio­phar­ma­ceu­ti­cals to the group — while aim­ing for 60 “ma­jor” reg­u­la­to­ry sub­mis­sions from 2019-2022. And it’s al­ready lin­ing up promised ap­provals for next year, bet­ting that they can shoot for key reg­u­la­to­ry OKs based on the da­ta in hand.

The move to ease con­cerns about the com­pa­ny’s fu­ture rev­enues comes af­ter No­var­tis re­port­ed that the FDA had re­ject­ed its big ap­pli­ca­tion to sell canakinum­ab for heart dis­ease, wip­ing out one of their ear­li­er boasts, with a de­ci­sion on the gener­ics side of the busi­ness to throw in the tow­el on a Rit­ux­an copy­cat rather than try to make a mark as a run­ner-up in that heav­i­ly con­test­ed field.

Of all the Big Phar­ma play­ers, No­var­tis has been one of the least re­luc­tant to pro­mote the scale of its in-house work, with lots of big num­bers when it comes to fu­ture op­por­tu­ni­ties for drugs that can earn $1 bil­lion or more per year. Even in late-stage de­vel­op­ment, though, the odds of suc­cess can be daunt­ing — and No­var­tis will find plen­ty of chal­lenges in get­ting these drugs to mar­ket.

Keep in mind, No­var­tis is one of the top spenders in R&D, with a bud­get of close to $9 bil­lion last year — just be­hind Roche and Mer­ck. And that rais­es the bar con­sid­er­ably on their per­for­mance in an era of steadi­ly dwin­dling ROI for the top com­pa­nies in drug de­vel­op­ment.

Here are the top drugs now spot­light­ed in late-stage de­vel­op­ment at No­var­tis:

  • AVXS101, which No­var­tis says should be good to go for a mar­ket­ing ap­proval in H1 of next year. Back in April, Narasimhan made his biggest bet yet with his $8.7 bil­lion deal to buy AveX­is and ex­pand the com­pa­ny’s pro­file in gene ther­a­py. It was a bold move, and there are plen­ty of great ex­pec­ta­tions on the line af­ter this pro­gram de­liv­ered some im­pres­sive re­sults for spinal mus­cu­lar at­ro­phy. This could be a big headache for Bio­gen, which has been rack­ing up big sales for its SMA drug Spin­raza — which al­so high­lights No­var­tis’ op­por­tu­ni­ty.
  • Mayzent (sipon­i­mod) should launch in Q1 for mul­ti­ple scle­ro­sis, says No­var­tis. Com­pa­ny of­fi­cials de­scribed this drug’s lat­est re­sults as “pret­ty much the first and on­ly study in sec­ondary pro­gres­sive MS that showed mean­ing­ful re­sults.” No­var­tis needs this one bad­ly as its $3.2 bil­lion fran­chise for Gilenya is about to get hit. An­a­lysts have of­fered a $3 bil­lion peak sales pro­jec­tion to help out.
  • Arz­er­ra — OMB157 (ofa­tu­mum­ab) — has caused plen­ty of headaches for No­var­tis this year. They were forced to pull it off the mar­ket out­side the US as com­pe­ti­tion heat­ed up for the leukemia drug. No­var­tis thinks it can re­pur­pose this drug, though, for MS, call­ing it a “next gen­er­a­tion B-cell de­ple­tor with a po­ten­tial­ly fa­vor­able safe­ty pro­file from faster b-cell re­ple­tion and pre­served im­mu­ni­ty, and with a con­ve­nient month­ly sub-cu­ta­neous dos­ing.”  
  • No­var­tis has a CRTh2 re­cep­tor an­tag­o­nist for mod­er­ate to se­vere asth­ma called QAW039 (fe­vip­iprant) which is be­ing lined up for a pitch. No­var­tis has in­sist­ed for years this oral ther­a­py is a po­ten­tial block­buster, but it hasn’t been in the spot­light as much as you might ex­pect for a would-be top con­tender.
  • RTH258 (brolu­cizum­ab) is slat­ed to be the big Re­gen­eron ri­val to Eylea that can slice away a chunk of the block­buster fran­chise with an eas­i­er dos­ing reg­i­men. It’s been a top con­tender at No­var­tis for some time, but an­a­lysts have be­gun to raise doubts as Re­gen­eron came on with its own new dos­ing strat­e­gy and Roche jumped in as well with its own con­tender, faricimab, which has 16-week da­ta to boast about.
  • No­var­tis has had plen­ty of is­sues with be­ing a lit­tle lat­er to the game than planned, and that has been on dis­play with its sick­le cell dis­ease drug SEG101 (crizan­l­izum­ab). The ther­a­py has demon­strat­ed a dou­bling of the re­sponse rate over place­bo in pre­vent­ing a painful va­so-oc­clu­sive cri­sis for pa­tients. But af­ter ini­tial­ly ink­ing in a 2018 fil­ing time­line, No­var­tis has shift­ed back to 2019.
  • Just a cou­ple of weeks ago No­var­tis ac­knowl­edged that reg­u­la­tors had bat­ted back its ap­pli­ca­tion to mar­ket ACZ885 (canakinum­ab) for car­dio risk re­duc­tion, but com­pa­ny ex­ecs im­me­di­ate­ly piv­ot­ed to their work in can­cer, with 3 Phase lll tri­als in ad­ju­vant NSCLC, 1st line NSCLC, and 2nd line NSCLC. No­var­tis says it has a shot at be­com­ing the “stan­dard of care in these set­tings,” but they of­ten hype prospects.

Not all of these drugs will make it, but they do help raise the bar for R&D per­for­mance in this sec­tor as oth­er Big Phar­ma ri­vals an­gle in with their own de­vel­op­ment strate­gies. No­var­tis has al­so shown that it’s ca­pa­ble of sur­prise, so don’t ex­pect this tal­ly to re­main sta­t­ic through 2019.


Im­age: Vas Narasimhan. AP IM­AGES

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.