Al­ler­gan goes on a buy­ing spree for NASH drugs, adding Akar­na in M&A dou­ble head­er

Brent Saun­ders, Al­ler­gan

Al­ler­gan $AGN is pulling out all the stops in ramp­ing up its own NASH pipeline in record time. Just hours af­ter an­nounc­ing plans to bag To­bi­ra $TBRA for a jaw-drop­ping pre­mi­um in a $1.7 bil­lion deal, the fast-grow­ing phar­ma bagged the fledg­ling UK biotech Akar­na for $50 mil­lion up­front and an un­spec­i­fied set of mile­stones.

This new deal adds Akar­na’s lead ther­a­py, one of its non-bile acid FXR ag­o­nists dubbed AKN-083. And there are more pre­clin­i­cal FXR ther­a­pies in the works that will now be fed in­to Al­ler­gan’s overnight R&D ex­pan­sion. Akar­na an­nounced a mod­est $15 mil­lion B round back in Feb­ru­ary.

Akar­na is fo­cused on a nu­clear hor­mone re­cep­tor ex­pressed in the liv­er, which many be­lieve is the kind of mas­ter reg­u­la­tor that can be used to treat NASH, a fat­ty liv­er dis­ease that’s grow­ing rapid­ly. In­ter­cept’s $ICPT Ocali­va, ap­proved in the US, tar­gets FXR. Gilead’s $GILD ex­per­i­men­tal GS-9674 is al­so a play­er. Al­ler­gan will now set out to try and beat them both in up­com­ing clin­i­cal stud­ies.

Al­ler­gan an­nounced this morn­ing that it had agreed to pay To­bi­ra’s in­vestors six times what their stock was worth at the close of busi­ness on Mon­day. That deal de­liv­ered two drugs, in­clud­ing ceni­crivi­roc, which flunked a Phase IIb study for NASH in Ju­ly. The South San Fran­cis­co-based biotech, though, said it got enough pos­i­tive da­ta on a sec­ondary end­point to war­rant a move in­to a piv­otal Phase III pro­gram.

Al­ler­gan CEO Brent Saun­ders has said he plans a se­ries of step­ping stone deals to beef up the pipeline, with new deals rang­ing from Phase I through late-stage de­vel­op­ment. He’s not wait­ing around to sa­vor each one, in­stead choos­ing to leap from one to the next. Al­ler­gan ac­quired Vi­tae just a few days ago, and more deals are clear­ly in the works.

David Nichol­son, Chief Re­search & De­vel­op­ment Of­fi­cer, Al­ler­gan, had this to say about deal num­ber two:

“AKN-083 is a high­ly dif­fer­en­ti­at­ed, se­lec­tive FXR ag­o­nist which is a strong­ly val­i­dat­ed ther­a­peu­tic mech­a­nism for the treat­ment of NASH. In ad­di­tion, AKN-083 is a non-bile acid FXR ag­o­nist that in pre­clin­i­cal stud­ies has shown high affin­i­ty, po­ten­cy and se­lec­tiv­i­ty with a bet­ter tol­er­a­bil­i­ty pro­file. These char­ac­ter­is­tics make AKN-083 a great ad­di­tion to our port­fo­lio of as­sets for the treat­ment of NASH.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

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Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

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Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.