Novartis' manufacturing hub in Stein, Switzerland (Novartis)

UP­DAT­ED: Swiss CD­MO Celonic finds a home at No­var­tis' Stein hub, plans to add 250 new jobs cen­tered on next-gen drugs

The out­sourc­ing mar­ket for cell and gene ther­a­pies has stayed red-hot in re­cent months as some of the biggest CD­MOs — and even ma­jor drug­mak­ers — are div­ing in. Now, a Swiss CD­MO wants a big­ger piece of the ac­tion, and it’s look­ing to set up shop in No­var­tis’ fledg­ling life sci­ences hub in Stein.

Celonic plans to build a 91,500-square-foot man­u­fac­tur­ing cen­ter fo­cused on cell and gene ther­a­pies, next-gen vac­cines and oth­er “in­no­v­a­tive” drugs as part of a two-part ex­pan­sion at No­var­tis’ Rhine Val­ley hub, the CD­MO said last week.

The ex­pan­sion will add rough­ly 250 work­ers at the site, Celonic said, as well as up to 20 man­u­fac­tur­ing clean rooms, and lab and of­fice space. The fa­cil­i­ty is set to open in Q2 2022, Celonic said.

Celonic makes the third drug­mak­er to call No­var­tis’ Life Sci­ence Park Rhein­tal in Stein — for­mer­ly just a pro­duc­tion site — home. The area cur­rent­ly hosts both No­var­tis and Lon­za, Celonic said, with as many as 2,000 em­ploy­ees work­ing there.

In news that didn’t make much of a wave state­side, No­var­tis an­nounced in mid-Feb­ru­ary that it planned to shift its Stein lo­ca­tion in­to a life sci­ences hub as part of an ef­fort to drum up in­vest­ment in the Rhine Val­ley and es­tab­lish a cen­ter of pro­duc­tion for cell and gene ther­a­pies. No­var­tis it­self has in­vest­ed around $217 mil­lion in ex­pan­sions in Stein and Schweiz­er­halle in 2020 and 2021, adding to its own foot­print in the re­gion.

A No­var­tis spokesper­son said the firm was on the hunt for oth­er com­pa­nies to jump on board.

“We are ba­si­cal­ly open to all types of com­pa­nies for well-known large com­pa­nies as well as for small or medi­um-sized start-ups,” the spokesper­son told End­points News. “We are cur­rent­ly in talks with po­ten­tial part­ners whether there is in­ter­est in mov­ing to Stein and ben­e­fit­ing from our wide range of ser­vices. It is im­por­tant to know that this is a process that will take place over the next few years and that the change will be grad­ual.”

Of course, cell and gene ther­a­pies are not a new tar­get of in­vest­ment in the con­tract man­u­fac­tur­ing space, with some of the biggest CD­MOs mak­ing mas­sive down pay­ments on the tricky-to-make ther­a­peu­tics.

Late last month, out­sourc­ing gi­ant Catal­ent dove even fur­ther in­to the field with its ac­qui­si­tion of plas­mid DNA spe­cial­ist Del­phi Ge­net­ics and the launch of man­u­fac­tur­ing ser­vices in that space at its Rockville, MD fa­cil­i­ty. Del­phi, found­ed in 2001 and head­quar­tered near Catal­ent’s fa­cil­i­ty in Gos­selies, Bel­gium, will add a 17,000 square-foot fa­cil­i­ty to the Catal­ent fold spe­cial­iz­ing in all stages of clin­i­cal plas­mid sup­ply.

Back in Feb­ru­ary 2020, Catal­ent shelled out $315 mil­lion for cell ther­a­py spe­cial­ist MaS­Ther­Cell Glob­al and its 32,000 square-foot fa­cil­i­ty in Hous­ton along with a 25,000 square-foot fa­cil­i­ty in Gos­selies. MaS­Ther­Cell al­so plot­ted a 60,000 square-foot ad­di­tion in Bel­gium that’s set to open in fall 2021.

In Oc­to­ber of last year, Catal­ent ac­quired an­oth­er Gos­selies cell and gene ther­a­py play­er, Bone Ther­a­peu­tics, and its 31,000-square-foot site for a mea­ger $14 mil­lion. A month ear­li­er, Catal­ent out­lined its plans to in­fuse $130 mil­lion in­to its cell and gene ther­a­py man­u­fac­tur­ing fa­cil­i­ty in Har­mans, MD, specif­i­cal­ly tar­get­ing late clin­i­cal-stage sup­ply.

Mean­while, even the big drug­mak­ers are writ­ing checks to dou­ble down in the space. In Feb­ru­ary, Bris­tol My­ers Squibb said it will add a 244,000 square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its De­vens, MA site as it looks to grow its pro­duc­tion ca­pac­i­ty around new­ly ap­proved liso-cel and, po­ten­tial­ly, ide-cel in the com­ing weeks.

The 89-acre De­vens site in the Boston area will hold the fourth in-house cell ther­a­py man­u­fac­tur­ing site for Bris­tol, along­side fa­cil­i­ties in Both­ell, WA; and War­ren and Sum­mit, NJ. Bris­tol al­so counts con­tract part­ners in the EU and Japan as part of its cell ther­a­py net­work.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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