Brett Monia, Ionis Pharmaceuticals CEO

Io­n­is to build new man­u­fac­tur­ing site in South­ern Cal­i­for­nia, dou­bling the size of its cur­rent site

As Io­n­is con­tin­ues to net ma­jor deals and col­lab­o­ra­tions with large phar­ma com­pa­nies, the Cal­i­for­nia-based biotech is look­ing to ex­pand its man­u­fac­tur­ing ca­pac­i­ty.

Io­n­is will have a chem­istry and man­u­fac­tur­ing site built in the city of Ocean­side, CA, north of San Diego. Re­al es­tate de­vel­op­ment com­pa­ny Sud­bury Prop­er­ties will con­struct the 217,000-square-foot fa­cil­i­ty, with Io­n­is adding the fin­ish­ing touch­es.

While the cost of the fa­cil­i­ty was not pro­vid­ed to End­points News, the terms of the agree­ment will see Io­n­is lease the prop­er­ty for 20 years with two 10-year op­tions to re­new, and the com­pa­ny can be the first to pur­chase the prop­er­ty if it so choos­es.

The fa­cil­i­ty is ex­pect­ed to be com­plet­ed by 2025 and will start pro­duc­ing ac­tive phar­ma­ceu­ti­cal in­gre­di­ents by 2026. Ac­cord­ing to the biotech, this fa­cil­i­ty will be dou­ble the size of Io­n­is’ man­u­fac­tur­ing site in Carls­bad, CA.

End­points reached out to Io­n­is for more in­for­ma­tion, but did not re­ceive a re­sponse by press time and will up­date the sto­ry if more de­tails come in.

“From our in­cep­tion, Io­n­is has been com­mit­ted to dis­cov­er­ing and de­vel­op­ing trans­for­ma­tion­al med­i­cines for pa­tients who de­pend on us. Our new Ocean­side cam­pus will pro­vide the ca­pac­i­ty we need to sup­port our grow­ing pipeline, new tech­nolo­gies and chemistries,” said Io­n­is’ CEO Brett Mo­nia in a state­ment.

The move for Io­n­is comes as the com­pa­ny has been link­ing up with ma­jor names in phar­ma. In the sum­mer, Io­n­is an­nounced that Roche is in-li­cens­ing and ad­vanc­ing an an­ti­sense drug can­di­date in­to a Phase III clin­i­cal study. The drug is be­ing in­ves­ti­gat­ed for im­munoglob­u­lin A nephropa­thy (IgAN), a kid­ney dis­ease that can lead to re­nal fail­ure. Roche put down $75 mil­lion to li­cense the drug can­di­date in 2018.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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