Mi­cro­cap Cona­tus teams up with phar­ma gi­ant No­var­tis on NASH drug, shares rock­et up

Steven J. Men­to, Cona­tus

The mi­cro­cap biotech Cona­tus Phar­ma­ceu­ti­cals $CNAT just struck a li­cens­ing deal with No­var­tis for its lead drug that’s worth about as much as its mar­ket cap at to­day’s close — and that’s just the cash por­tion of the agree­ment. Its share price rock­et­ed up, climb­ing 146% in ear­ly-morn­ing trad­ing Tues­day.

San Diego-based Cona­tus is get­ting $50 mil­lion up­front from phar­ma gi­ant No­var­tis, which gets an op­tion on em­ri­c­as­an 9 months af­ter the drug hit a slate of bio­mark­er end­points in a small mid-stage study for fat­ty liv­er dis­ease and NASH. No­var­tis is pay­ing half of the Phase IIb costs and will hand over an­oth­er $7 mil­lion if it ex­er­cis­es its op­tion in the deal.

No­var­tis will al­so hand over an un­spec­i­fied batch of mile­stones and has re­tained the right to co-com­mer­cial­ize the drug in the US. No­var­tis is re­spon­si­ble for late-stage test­ing.

The No­var­tis deal sub­stan­tial­ly changes the for­tunes of this small biotech. Cona­tus end­ed the day with a mar­ket cap of $51 mil­lion. Its CEO Steven J. Men­to had this to say:

This col­lab­o­ra­tion val­i­dates the Cona­tus em­pha­sis on the ini­tial de­vel­op­ment of em­ri­c­as­an as a sin­gle agent treat­ment for NASH cir­rho­sis in both com­pen­sat­ed and de­com­pen­sat­ed pa­tients, and sets the stage for si­mul­ta­ne­ous de­vel­op­ment of oral com­bi­na­tion ther­a­pies for the treat­ment of NASH fi­bro­sis in­clud­ing em­ri­c­as­an and one of the No­var­tis in­ter­nal FXR (Far­ne­soid X re­cep­tor) ag­o­nists in clin­i­cal de­vel­op­ment. Their strong com­mit­ment to and ex­per­tise in liv­er dis­ease, and proven record of suc­cess in drug de­vel­op­ment pro­vide our best op­por­tu­ni­ty to de­liv­er these po­ten­tial­ly ground­break­ing new ther­a­pies to chron­ic liv­er dis­ease pa­tients with high un­met med­ical need.

Paul Hudson, Sanofi CEO (Getty Images)

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After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

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Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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De­nali un­veils new way of cross­ing blood brain bar­ri­er as the big neu­ro­science bet en­ters its clin­i­cal years

Five years ago, as much of pharma began leaving neuroscience, three big-name scientists from Genentech and some A-list investors, including ARCH and Flagship, made a $217 million bet that new genetic insights and a reliance on biomarkers could bring them success. They called it Denali Therapeutics.

Still, Denali faced the problem that neuroscience developers have faced for decades: How do you get a large molecule across the blood-brain barrier, a natural defense evolved precisely to keep them out? Enzyme replacement therapy, for instance, would be a great candidate to treat several neurological disorders, but enzymes can’t cross the barrier.