Ani Phar­ma picks up gener­ic play­er for a cool $210M, tur­bocharg­ing its man­u­fac­tur­ing and R&D wings

Con­tract man­u­fac­tur­ing work has grown at a rapid clip the past year giv­en de­mand caused in part by Covid-19. Big play­ers are dou­bling down on their pro­duc­tion foot­prints, and even small play­ers are tak­ing big swings to get in­to the game.

Min­neso­ta’s Ani Phar­ma­ceu­ti­cals will shell out $89.5 mil­lion in cash and $74 mil­lion in eq­ui­ty to ac­quire New Jer­sey gener­ics play­er Novi­tium Phar­ma, al­low­ing it rapid­ly scale its man­u­fac­tur­ing and R&D in­fra­struc­ture for gener­ics, the drug­mak­er said this week.

The deal comes with an ad­di­tion­al $46.5 mil­lion in po­ten­tial fu­ture pay­outs, bring­ing the over­all val­ue of the ac­qui­si­tion to around $210 mil­lion, Ani said.

Ani will im­me­di­ate­ly add Novi­tium’s ad­vanced pipeline of gener­ic drugs, where it has pro­ject­ed 25 or more new launch­es in the next year. But the ac­qui­si­tion will al­so bol­ster con­tract man­u­fac­tur­ing and R&D work mov­ing for­ward.

Novi­tium will bring nine new cus­tomers in­to the fold as well as a 50,000-square-foot fa­cil­i­ty in East Wind­sor, New Jer­sey fa­cil­i­ty with 27 man­u­fac­tur­ing suites and eight clin­i­cal suites. That fa­cil­i­ty is al­so cur­rent­ly un­der­go­ing a 20,000-square-foot ex­pan­sion that will bring an­oth­er 18 man­u­fac­tur­ing suites on­line. The com­pa­ny’s an­nu­al pro­duc­tion ca­pac­i­ty is around 2 bil­lion dos­es of its tablets, cap­sules, liq­uid sus­pen­sions and so­lu­tions, pow­ders and pow­der for oral sus­pen­sion, con­trolled re­lease and po­tent com­pounds.

On the R&D side, Novi­tium will bring over the 21 ab­bre­vi­at­ed new drug ap­pli­ca­tions it cur­rent­ly has filed with the FDA and more than 30 oth­er prod­ucts un­der de­vel­op­ment, Ani said. The drug­mak­er al­so has three 505(b)(2) can­di­dates in on­col­o­gy and hy­per­ten­sion un­der de­vel­op­ment — ef­fec­tive­ly drugs that fall some­where in the mid­dle be­tween gener­ics and NDAs.

The ac­qui­si­tion comes as busi­ness in the con­tract man­u­fac­tur­ing field has run red hot in re­cent months with Covid-19 up­ping the de­mand for sup­ply chain re­dun­dan­cy and big work or­ders.

Just this week, ma­jor CD­MO play­er Ther­mo Fish­er Sci­en­tif­ic an­nounced plans to drop $600 mil­lion in­to its glob­al man­u­fac­tur­ing net­work as part of a move to ramp up its short-term Covid-19 work and more than dou­ble its ca­pac­i­ty for the fu­ture.

Tar­get­ing 11 sites spread through­out the Amer­i­c­as, Eu­rope and Asia, Ther­mo ex­pects to add 1,500 em­ploy­ees to its glob­al work­force in or­der to ex­pand its bio­pro­cess­ing ca­pac­i­ty for sin­gle-use tech, cell cul­ture me­dia and pu­rifi­ca­tion. The ex­pan­sions are set to be com­plet­ed by 2022.

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.

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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:

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Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

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Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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