Daniel Getts, Myeloid Therapeutics CEO

Myeloid Ther­a­peu­tics goes down un­der for new man­u­fac­tur­ing site, with $66M lo­cal in­vest­ment

Myeloid Ther­a­peu­tics is look­ing across the Pa­cif­ic to es­tab­lish a new man­u­fac­tur­ing site, and will be net­ting some ma­jor as­sis­tance from the lo­cal gov­ern­ment as well.

The Cam­bridge, MA-based biotech an­nounced that it is col­lab­o­rat­ing with the gov­ern­ment of New South Wales in Aus­tralia to build a new RNA man­u­fac­tur­ing and re­search fa­cil­i­ty. The fa­cil­i­ty will aim to speed up the com­mer­cial­iza­tion of Myeloid’s RNA ther­a­peu­tics, with the New South Wales gov­ern­ment in­vest­ing AU 96 mil­lion ($65.7 mil­lion) in­to the fa­cil­i­ty.

Ac­cord­ing to Myeloid CEO Daniel Getts in an in­ter­view with End­points News, the fa­cil­i­ty will be lo­cat­ed on the Cam­pus of Mac­quar­ie Uni­ver­si­ty in the Syd­ney area, top­ping out at around 2,500 square me­ters, or over 26,000 square feet. The new site will be able to pro­duce syn­thet­ic RNA as well as mR­NA and lipid for­mu­la­tion. It will in­clude lab space as well.

The site, ex­pect­ed to be done by 2024 and to be op­er­a­tional by 2025, will have a head­count of around 67, Getts said.

Acord­ing to Getts, a na­tive of Aus­tralia, the com­pa­ny has se­lect­ed New South Wales for sev­er­al fac­tors, telling End­points:

Dur­ing the Covid pan­dem­ic, there was not even a place to buy GMP plas­mids in Aus­tralia. And plas­mid is an im­por­tant, raw ma­te­r­i­al if you like that goes in­to mak­ing GMP RNA. So there’s a sig­nif­i­cant hole with­in the in­fra­struc­ture.

He al­so added that what is unique about New South Wales is that the re­gion has made strides in RNA re­search over the last 30 years, par­tic­u­lar­ly with cir­cu­lar RNA work. Getts al­so said that with­in New South Wales, 14 uni­ver­si­ties are do­ing work in the RNA space, which presents an op­por­tu­ni­ty for the new fa­cil­i­ty to help trans­late and ad­vance tech­nolo­gies that come out of those in­sti­tu­tions.

“As a pop­u­la­tion, Aus­tralia’s quite small but what the New South Wales Gov­ern­ment has done, what I think is unique, are they’ve ac­tu­al­ly formed a coali­tion with those 14 uni­ver­si­ties and all the RNA tech­nol­o­gy is go­ing in­to one buck­et,” Getts said.

With­in the new fa­cil­i­ty, Myeloid will be tak­ing around 25% of space for its man­u­fac­tur­ing pur­pos­es, while an­oth­er 25% will go to the “gov­ern­ment’s se­lect­ed cus­tomers,” ac­cord­ing to Getts. The re­main­ing 50% will be used by an un­named CD­MO part­ner.

As for sep­a­rat­ing them­selves from the pack, Getts said that one of the dis­tin­guish­ing fac­tors that Myeloid’s fa­cil­i­ty will have, and why it will be suc­cess­ful, is that it is fo­cused on tak­ing the idle ca­pac­i­ty and hav­ing that as a ser­vice busi­ness.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eli Lil­ly set­tles in­sulin pric­ing law­suit for $13.5M, month­ly out-of-pock­et com­mit­ment

Eli Lilly will pay $13.5 million and continue to cap out-of-pocket insulin costs at $35 per month for the next four years in what plaintiffs called an “icebreaker” class settlement to a years-long drug pricing suit.

Insulin users filed suit against Eli Lilly, Novo Nordisk and Sanofi in 2017, accusing the drugmakers of “artificial and fraudulent inflation” of their insulin prices in the US. In an amended complaint filed in 2021, plaintiffs alleged the companies raised their list prices “in perfect lockstep” by more than 150% over a five-year period.

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Mar­ket­ingRx roundup: Bio­gen be­gins so­cial aware­ness around post­par­tum de­pres­sion; Phar­ma mar­keters in the NBA games

As Biogen and Sage Therapeutics await an FDA decision on postpartum depression (PPD) candidate zuranolone, they’re taking the first steps to drive awareness of the condition. A social media ad on Facebook directs users to a Biogen landing page featuring one of its own employees named Caitlin, a young mother who tells her story of PPD after her first child was born several years ago.

A Biogen spokesperson clarified that the work is not part of a broader campaign but is more in line with the importance of highlighting stories in mental health — in this case for women living with PPD.

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Vi­a­tris re-ups med­ical ed­u­ca­tion spon­sor­ship pledge, adds health eq­ui­ty to pri­ma­ry care train­ing

Viatris is adding to its sponsored medical education platform with new modules around health equity and social determinants of health. While an initiative called NCD Academy focuses on the five major contributing areas of non-communicable diseases (NCDs) — cardiovascular, diabetes, mental health, oncology and respiratory — Viatris and its content partners, the American College of Cardiology, NCD Alliance and World Heart Federation, realized there was also social needs.

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Amylyx co-CEOs Justin Klee (L) and Joshua Cohen (Cody O'Loughlin/The New York Times; courtesy Amylyx)

EU com­mit­tee like­ly to rec­om­mend against ap­prov­ing Amy­lyx ALS drug, com­pa­ny says

Amylyx Pharmaceuticals’ ALS drug is seemingly headed for a rockier path in the EU than it faced in the US and Canada.

The biotech announced Tuesday morning that the bloc’s drug review committee, known as CHMP, is expected to issue a “negative opinion” and recommend against approving the drug next month. If that negative opinion comes to pass, Amylyx expects to appeal in a “formal re-examination,” per a company press release.

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Al­ny­lam files a new set of law­suits against Mod­er­na and Pfiz­er over Covid-19 vac­cines

Alnylam has once again accused Pfizer and Moderna of infringing patents around its lipid nanoparticle technology.

In two lawsuits filed Friday, Alnylam alleged that Pfizer and Moderna benefited from the lipid particle technology it invented more than a decade ago. Also known as LNPs, the particles protect mRNA molecules once administered inside the body, and also help escort it across cell membranes. Once inside a cell, they unpack mRNA’s essential protein-building instructions to create, for example, spike proteins to prime the immune system against Covid-19.

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FDA in­spec­tion of UCB fa­cil­i­ty in Bel­gium finds sev­er­al qual­i­ty is­sues

UCB, a Brussels-based biopharmaceutical company, had several issues cited by FDA inspectors at a manufacturing facility in Belgium, but the company is not panicking.

According to a 483 report, the FDA inspected UCB’s manufacturing facility in Braine-l’Alleud, Belgium, between April 17 and 21 of this year, with inspectors finding three significant observations.

The FDA found issues with the quality unit at the facility surrounding its control of documents. The report said that UCB had “uncontrolled” logs recording cleaning activities in classified areas, among other examples of “uncontrolled” logs being used. Inspectors also found shredded documents at the facility but had no assurance that the materials did not contain quality documents.

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Emer­gent to de­liv­er a $120M con­tract for the small­pox vac­cine for the US stock­pile

Emergent BioSolutions, a vaccine and therapeutic manufacturer for defense purposes, is cementing its smallpox vaccine production status by inking a contract with the US government.

On Tuesday, Emergent announced that it has a contract to deliver the ACAM200 smallpox vaccine to the Strategic National Stockpile. Emergent said in a release that this option is the third of nine annual contract extensions, with this extension being worth around $120 million. The contract is also a part of Emergent’s 10-year, $2 billion deal with HHS’s Office of the Assistant Secretary for Preparedness and Response set up in 2019.

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Chiquita Brooks-LaSure, Centers for Medicare and Medicaid Services administrator (Caroline Brehman/CQ Roll Call via AP Images)

Clar­i­ty want­ed: When can new drug price ne­go­ti­a­tions be chal­lenged in court?

The inevitable lawsuit over the incoming rules around how the CMS plans to negotiate some of the most expensive drug prices has the Congressional Research Service already calling on Congress to be more clear about the types of legal challenges it intends to prohibit under the new law.

Gilead recently said that select provisions of the Inflation Reduction Act “may become subject to legal challenges” even as the CRS points to speculative areas that may be challenged and certain areas that may not be subject to judicial review.

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