Are the stars lining up for a major M&A deal at Novartis?

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

Two big things are going on right now at Novartis that have the investor crowd on high alert.

First, CEO Vas Narasimhan has signaled he’s now ready to sell or spin off the big generics arm, Sandoz. In Big Pharma land, anything that drags on performance — like consumer arms with aging therapeutics — is being hived off as organizations zero in on innovation as the future.

Second, they just sold that big block of Roche shares for $21 billion. And what do they plan to do with all that money?

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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.

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.

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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.

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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.

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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.

President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Pfizer’s pill to treat Covid-19 is outpacing its top rival from Merck not only in terms of efficacy data but now in the size of its US government contract, too.

The US on Thursday announced it will pay $5.29 billion for 10 million courses of Pfizer’s potential treatment, which is the largest single procurement of any therapeutic or vaccine since the pandemic began. And at $529 per course for the Pfizer pill, that’s significantly cheaper than the $2.2 billion the US paid for just 3 million courses of Merck’s treatment, which adds up to about $730 per course.

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.

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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.
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