Endo International is expanding its manufacturing capacity at a subsidiary to help out the US national stockpile, and it’s getting funding from the government to do so.
Par Sterile Products will expand the sterile fill-finish capacity at a Rochester, MI site to up the defense efforts against future pandemics. The company will establish a new line that’s fit with the capability of processing liquid or lyophilized products that require Biosafety Level 2 containment. It will also provided inspection and packaging capacity, and the government will fund the majority of the project — $90 million of the $120 million total cost.
‘Endo strives to be a force for good, and we are proud to partner with the U.S. government in its efforts to expand and accelerate domestic manufacturing in support of future pandemic preparedness,’ Endo CEO Blaise Coleman said in a press release. ‘This collaboration underscores our longstanding history as a U.S. manufacturer of high-quality medicines.’
The agreement is part of the Defense Protection Act, which addresses vulnerabilities in the supply chain, and looks to advance manufacturing.
Endo reached an agreement with the Irish government to provide its Vasostrict vials for injections to healthcare providers in hopes of upping supply for medications critically needed to treat cases of Covid-19 earlier this month. That is also produced at the Rochester facility, and the deal addresses widespread industry drug shortages, and the supply chain issues the industry is currently experiencing.
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Thermo Fisher CEO Mark Casper
Another week, another win for the North Carolina biotech community.
This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.
The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.
Unlock this story instantly and join 123,600+ biopharma pros reading Endpoints daily — and it’s free.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
Unlock this story instantly and join 123,600+ biopharma pros reading Endpoints daily — and it’s free.
Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
Unlock this story instantly and join 123,600+ biopharma pros reading Endpoints daily — and it’s free.
A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.
The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.
The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.
The holding company of a South Korean vaccine maker is in the final talks to make an investment into a US gene therapy firm.
SK Biosciences is in the process of signing a deal with the Center for Breakthrough Medicines (CBM), a Philadelphia-based CDMO. If finalized, the deal will come eight months after SK’s takeover of the French gene and cell therapy company Yposkesi.
With this move, SK takes itself a step closer to establishing a value chain of synthetic and bio pharmaceuticals in the US, Europe and Asia by 2025, the company’s head of the investment center Lee Dong-hoon said in a presentation. The CBM is known for its production of plasmid DNA. With SK’s investment, it will expand manufacturing facility in the Cellicon Valley cell and gene therapy cluster by 699,654 square feet.
Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
Unlock this story instantly and join 123,600+ biopharma pros reading Endpoints daily — and it’s free.
Sree Kant, BAKX Therapeutics CEO
BAKX Therapeutics emerged from stealth in a big way back in July, striking an $852 million deal with Ipsen for its lead cancer candidate, a small molecule designed to activate the body’s natural process for programmed cell death. And Ipsen’s putting a bit more cash in the company’s coffers to see that program into the clinic.
CEO Sree Kant unveiled a $25 million Series A round on Thursday, led by AB Magnitude Ventures Group with a hand from Ipsen and Sherpa Healthcare Partners. The funds will be used to advance the company’s BAKX activator program, which traces back to pioneering work around apoptosis by the Dana-Farber Cancer Institute’s Loren Walensky and Albert Einstein College of Medicine’s Evripidis Gavathiotis.
J&J and AbbVie are competing for the same Crohn’s disease market with their respective IL-23 drugs, Tremfya and Skyrizi. On Wednesday, J&J’s Janssen unit revealed data it thinks could prove a key differentiator but appears to lack key context.
In long-term, Phase II follow-up data stretching to 48 weeks, 65% of patients taking Tremfya saw their Crohn’s disease enter clinical remission, J&J announced. The company did not say what proportion of patients hit remission in the placebo group, however, saying researchers didn’t measure for comparison to placebo after week 12.
https://endpts.com/endo-partners-up-with-us-government-on-120m-infusion-into-the-national-stockpile/
