No­var­tis joins the Big Phar­ma ex­o­dus out of an­tibi­otics, dump­ing re­search, cut­ting 140 and out-li­cens­ing pro­grams

An­oth­er Big Phar­ma is re­treat­ing from the an­tibi­otics field.

No­var­tis to­day says its ear­ly-stage re­search group at NI­BR is drop­ping an­tibac­te­r­i­al and an­tivi­ral re­search pro­grams based in Emeryville, CA. And they’re do­ing it at a time that drug-re­sis­tant strains of bac­te­ria are spread­ing around the world — an is­sue that once com­mand­ed con­sid­er­able at­ten­tion at No­var­tis.

The re­or­ga­ni­za­tion will trig­ger the lay­off of about 140 staffers. No­var­tis not­ed:

The groups that are im­pact­ed in their en­tire­ty are an­tibac­te­r­i­al and an­tivi­ral re­search. As a re­sult, oth­er groups are al­so af­fect­ed in­clud­ing, Phar­ma­col­o­gy, Pro­tein Sci­ences, Pro­ject Man­age­ment and glob­al sup­port func­tions in Glob­al Dis­cov­ery Chem­istry, NI­BR In­for­mat­ics, Sci­en­tif­ic Op­er­tions and Trans­la­tion­al Med­i­cine. About 150 em­ploy­ees will re­main in the San Fran­cis­co Bay Area in sup­port of NITD and our drug dis­cov­ery ef­forts.

On the chop­ping block are a group of pre­clin­i­cal pro­grams as well as LYS228, their clin­i­cal-stage ef­fort in the field. Most of the af­fect­ed staffers will have a 60-day pe­ri­od to work out their de­par­ture, with sev­er­ance, while a small group will stay on to han­dle the shut­down.

No­var­tis added:

While the sci­ence for these pro­grams is com­pelling, we have de­cid­ed to pri­or­i­tize our re­sources in oth­er ar­eas where we be­lieve we are bet­ter po­si­tioned to de­vel­op in­no­v­a­tive med­i­cines that will have a pos­i­tive im­pact for pa­tients. The need for these types of med­i­cines is clear and to max­i­mize the chances that these pro­grams will one day help pa­tients we are ac­tive­ly en­gaged in out-li­cens­ing dis­cus­sions with com­pa­nies fo­cused on de­vel­op­ing med­i­cines in these ar­eas.

This isn’t the first time NI­BR has re­or­ga­nized. There was a con­sid­er­able re­vamp short­ly af­ter Jay Brad­ner took the reins at the in­sti­tutes. And No­var­tis it­self is known for a rest­less search for cost cuts wher­ev­er it can find them — which trig­gered their de­ci­sion to scrap a spe­cial gene and cell ther­a­py unit and in­ter­grate the group in the main de­vel­op­ment or­ga­ni­za­tion. 

Phar­ma start­ed bail­ing on an­tibi­otics re­search years ago, dis­cour­aged by the no­table ab­sence of prof­its as gener­ics dom­i­nat­ed treat­ment. That left R&D to a small group of biotechs look­ing to come up with new ap­proach­es that could be used as drug-re­sis­tance be­come in­creas­ing­ly com­mon.

The sur­viv­ing play­ers will now get a chance to pick over what is be­ing scrapped now, just as As­traZeneca once tried to sell of their unit near Boston — un­til they were forced to fi­nal­ly spin it off as a new com­pa­ny.


Im­age: Jay Brad­ner, Pres­i­dent of the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, speaks at an End­points News event in San Fran­cis­co, Jan­u­ary 2018 — Jeff Ru­mans End­points News

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.