Clarus read­ies a slate of big PhI­II risk-shar­ing bets with a new $910M fund

About 8 years ago, the crew at Clarus Ven­tures had a sit down with a phar­ma com­pa­ny they were look­ing to sell one of their port­fo­lio biotechs to. The talks went well, the com­pa­ny want­ed the as­sets. But there was a big ob­sta­cle.

The buy­er they were talk­ing to couldn’t af­ford to just ac­quire the com­pa­ny and fit in an­oth­er late-stage drug pro­gram un­der its R&D bud­get. Those num­bers couldn’t change willy nil­ly — no mat­ter how good the new late-stage drug looked.

So Clarus got cre­ative. They agreed to come in with fund­ing for the Phase III, work­ing a deal on their pay­back for tak­ing on the risk. That cre­ative deal be­came a busi­ness at Clarus, and a good one at that, to hear them tell the sto­ry. They fol­lowed up with a string of deals with a line­up of top-20 phar­mas and now Clarus has raised $910 mil­lion more to fund the next wave.

“Over the past 7 years, half of our in­vest­ment strat­e­gy has been fo­cused on risk shar­ing,” Clarus Man­ag­ing Di­rec­tor Nick Galakatos tells me. Clarus IV — which broke well past its ini­tial $750 mil­lion goal — will al­low them to grow these kinds of struc­tured in­vest­ments past the top 20 with enough cash to fund rough­ly 12 to 14 more deals at $50 mil­lion to $300 mil­lion apiece.

This is a far cry from the clas­sic kind of ven­ture in­vest­ments that VCs make in life sci­ences. And Galakatos says it’s the kind of deal that should do well in the cur­rent re­strict­ed fi­nan­cial en­vi­ron­ment that phar­mas have to work with.

“For the most part the R&D bud­get of the ma­jor phar­ma com­pa­nies is con­strained,” says Galakatos. “They have a very ex­cit­ing pipeline and frankly they can­not fund their ex­ist­ing bud­get.” The risk-shar­ing deals pro­vide the added cash for the phar­mas to take more shots on goal, and there’s sub­stan­tial Phase II da­ta for Clarus to con­sid­er be­fore mak­ing a bet.

Not too sur­pris­ing­ly, can­cer deals are at the heart of this strat­e­gy, with red-hot im­muno-on­col­o­gy pacts as the cen­ter­piece. Phar­ma com­pa­nies in gen­er­al are loathe to pub­licly de­tail the num­bers be­hind deals like this and Galakatos knows the val­ue of re­main­ing dis­crete.

But he did of­fer that Clarus worked one struc­tured deal on ibru­ti­nib that was un­veiled, buy­ing a roy­al­ty stream from Roy­al­ty Phar­ma along­side Ais­ling Cap­i­tal when that drug was un­der re­view in 2013 by J&J and Phar­ma­cyclics. And of the 8 drugs they fi­nanced that made it through Phase III, he says, 5 are ap­proved and 3 more are be­ing po­si­tioned for a reg­u­la­to­ry de­ci­sion.

Clarus is ready for more.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.