Cel­gene/Ac­celeron win speedy FDA re­view for lus­pa­ter­cept in be­ta tha­lassemia; Ko­re­an in­vestor out to shake up Au­rini­a's board

Robert Fos­ter Con­traVir

→ As hoped, Cel­gene $CELG and its part­ners at Ac­celeron $XL­RN have se­cured pri­or­i­ty re­view for their red blood cell boost­ing drug, lus­pa­ter­cept, which has been pegged to even­tu­al­ly gen­er­ate peak sales of $2 bil­lion. The bi­o­log­ic has been de­vel­oped to man­age ane­mia re­sult­ing from myelodys­plas­tic syn­drome (MDS) as well as be­ta tha­lassemia. The FDA ex­pects to make its de­ci­sion on the be­ta-tha­lassemia in­di­ca­tion by De­cem­ber 4, while the MDS in­di­ca­tion will be dealt with by April 4, 2020. The Eu­ro­pean re­view of the drug is al­so un­der­way, the com­pa­nies said on Tues­day.

Au­rinia’s $AUPH largest share­hold­er is skep­ti­cal that the com­pa­ny’s lead­er­ship team is up to task com­mer­cial­iz­ing its lead drug, vo­closporin, as the Cana­di­an biotech revs up late-stage stud­ies in lu­pus and dry eye dis­ease. Ko­rea-based Iljin has nom­i­nat­ed three in­de­pen­dent di­rec­tors to the eight-mem­ber board in an at­tempt to rein in in­sid­ers who they say have been plac­ing self-in­ter­ests above those of in­vestors. Chief among the three nom­i­nees is Robert Fos­ter, the ex-CEO of Isotech­ni­ka whom Iljin cred­its for the dis­cov­ery of vo­closporin. The oth­er two, Soon-Yub (Samuel) Kwon and Myeong-Hee Yu, bring reg­u­la­to­ry and sci­en­tif­ic ex­per­tise, re­spec­tive­ly. CEO Pe­ter Green­leaf — re­cent­ly ap­point­ed af­ter stints at Cere­cor, Su­cam­po and Med­Im­mune — and chair­man George Milne have pre­vi­ous­ly urged in­vestors to re­ject Iljin’s nom­i­na­tions.

Robert Ian­none Linkedin

→ In April, the chief med­ical of­fi­cer of the em­bat­tled biotech Im­munomedics $IM­MU Robert Ian­none said he was leav­ing the com­pa­ny to work in Penn­syl­va­nia to be “close to his fam­i­ly.” On Mon­day, it was re­vealed that the for­mer As­traZeneca $AZN ex­ec­u­tive is head­ed to Jazz Phar­ma­ceu­ti­cals $JAZZ, where he will lead glob­al R&D.

→ Peanut al­ler­gy drug mak­er Aim­mune $AIMT pre­sent­ed da­ta from a rollover 28-week study on Tues­day that fol­lowed its land­mark piv­otal study. The re­sults sug­gest­ed that its treat­ment, AR101, can help pa­tients tol­er­ate high­er dos­es of peanut pro­tein, thus re­in­forc­ing the ra­tio­nale for con­tin­ued dai­ly dos­ing of AR101 be­yond one year, as test­ed in the late-stage PAL­ISADE tri­al. An FDA ap­proval de­ci­sion for AR101 is ex­pect­ed in Jan­u­ary 2020.

John Oyler BeiGene

→ In a sign of Chi­na’s grow­ing in­flu­ence on glob­al biotech, BeiGene chief John Oyler has been elect­ed to BIO’s board of di­rec­tors as well as the or­ga­ni­za­tion’s health sec­tion gov­ern­ing board.

→ Cam­bridge, Mass­a­chu­setts-based Strand Ther­a­peu­tics — which is fo­cused on gene ther­a­pies — has se­cured a $6 mil­lion seed round led by Play­ground Glob­al with par­tic­i­pa­tion from Alexan­dria Ven­ture In­vest­ments, AN­RI, and a group of pri­vate in­vestors. “This cap­i­tal will be in­stru­men­tal to build­ing out and scal­ing Strand’s mR­NA pro­gram­ming tech­nol­o­gy,” said Ja­cob Be­craft, the com­pa­ny’s co-founder and CEO, in a state­ment.

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)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

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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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

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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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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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.