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

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.