No­var­tis takes a $200M hit to write off a flop as ex­ecs spell out a cau­tious R&D strat­e­gy

With its top line locked in­to a hold­ing pat­tern as its sales teams strug­gle to ex­pand fran­chise rev­enue, No­var­tis has out­lined its near-term R&D strat­e­gy, tak­ing a $200 mil­lion hit to write off the dis­ap­point­ing heart drug sere­lax­in (RLX030) while look­ing be­yond a de­ci­sion lat­er in the year on its pi­o­neer­ing CAR-T drug as it shoots for new FDA fil­ings.

Joe Jimenez. No­var­tis

The phar­ma gi­ant said re­cent­ly that it has wrapped its ini­tial FDA ap­pli­ca­tion for CTL019. And in a new note out from Biren Amin the Jef­feries an­a­lyst pre­dicts that we’ll be see­ing the close­ly-watched fol­lowup da­ta from the JULI­ET study at the In­ter­na­tion­al Con­fer­ence on Ma­lig­nant Lym­phoma on June 14 in Lugano, Switzer­land.

Fol­low­ing a hoped-for ap­proval in CAR-T, No­var­tis re­vealed this morn­ing that its dis­cus­sions with reg­u­la­tors is en­cour­ag­ing the com­pa­ny to aim for a 2018 fil­ing for SEG101 (crizan­l­izum­ab) for sick­le cell pain crises af­ter it wraps the PK/PD com­pa­ra­bil­i­ty study to fi­nal man­u­fac­tur­ing process. Right along­side the phar­ma gi­ant’s R&D team will an­gle for an FDA ap­proval of BAF312 (sipon­i­mod) for re­laps­ing mul­ti­ple scle­ro­sis.

What you shouldn’t look for: Any big M&A pacts. Like a num­ber of its ma­jor league ri­vals, No­var­tis ex­ecs say that val­u­a­tions in biotech have reached a for­bid­ding high. No­var­tis CEO Joe Jimenez adds that the com­pa­ny’s BD team plans to move up­stream, to ear­li­er-stage as­sets and deals, as the com­pa­ny stays fo­cused on what you can get in a $2 bil­lion to $5 bil­lion bolt-on.

“The price of some of these as­sets has in­creased to the point that we don’t feel like we can cre­ate val­ue for No­var­tis share­hold­ers,’’ Chief Ex­ec­u­tive Of­fi­cer Joe Jimenez said on a con­fer­ence call Tues­day, ac­cord­ing to a re­port from Bloomberg.

Net in­come for No­var­tis slid 15% in the first quar­ter, which the com­pa­ny large­ly at­trib­uted to the $200 mil­lion charge on sere­lax­in. The write off for its one-time block­buster hope can’t come as any kind of sur­prise. A month ago No­var­tis said that its 4-year study of the heart drug flubbed the pri­ma­ry end­point, fail­ing to sig­nif­i­cant­ly cut the rate of car­dio­vas­cu­lar death or re­duce wors­en­ing heart fail­ure among pa­tients with acute heart fail­ure.

No­var­tis is left mak­ing slow progress with En­tresto, which has been grap­pling with wide­spread pay­er re­sis­tance. In the mean­time, its big flag­ship drug Gleevec is be­ing ham­mered by gener­ic com­pe­ti­tion.

No­var­tis gained an edge with the March ap­proval of Kisqali (ri­bo­ci­clib), a CDK 4/6 drug which looks like it will have to square off against Pfiz­er as well as Eli Lil­ly. And it re­worked its com­mer­cial­iza­tion pact with Am­gen on their late-stage mi­graine drug. But it’s al­so suf­fered oth­er set­backs in late-stage re­search, in­clud­ing the Phase III fail­ure last fall of Fo­vista for wet AMD, which has crimped its pipeline plans.

No­var­tis is in an awk­ward po­si­tion, un­will­ing or un­able to gam­ble big on new ef­forts and main­tain­ing a very care­ful ap­proach to the top line with­out a megablock­buster able to cap­ture grow­ing sales to fu­el its growth. The com­pa­ny is be­com­ing one of the most pre­dictable play­ers in Big Phar­ma, and that’s not nec­es­sar­i­ly a good thing.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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José Baselga, AstraZeneca cancer chief (Brent N. Clarke/FilmMagic via Getty Images)

As­traZeneca's Calquence nabs an­oth­er win against Im­bru­vi­ca, but Eli Lil­ly is on its heels

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Roche amps up its bis­pe­cif­ic at­tack on Eylea with more PhI­II da­ta — but just how threat­en­ing is it?

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.