La Jol­la feels the burn of ri­val malar­ia ap­proval; With an­oth­er $10B, Bay­er could fi­nal­ly weed out its her­bi­cide prob­lem

La Jol­la Phar­ma­ceu­ti­cal‘s shares $LJPC tum­bled about 20% to $5.48 on Wednes­day morn­ing af­ter an­oth­er com­pa­ny — Mary­land-based Ami­vas — was grant­ed FDA ap­proval for an IV for­mu­la­tion of an arte­sunate prod­uct for malar­ia. Arte­sunate is the ac­tive in­gre­di­ent used in La Jol­la’s lead ex­per­i­men­tal prod­uct, LJPC-0118, which is be­ing de­vel­oped for use in se­vere malar­ia. The Ami­vas news comes as a big blow to La Jol­la’s prospects as FDA reg­u­la­tions state that the agency will not ap­prove an­oth­er spon­sor’s mar­ket­ing ap­pli­ca­tion for the same drug for the same use or in­di­ca­tion with­in 7 years of the ini­tial ap­proval.

→ Ger­man drug­mak­er Bay­er, which has lost rough­ly $30 bil­lion in mar­ket val­ue since its $63 bil­lion buy­out of US agri­cul­tur­al gi­ant Mon­san­to in 2018, has long suf­fered the headache of deal­ing with the fall­out of Roundup, the her­bi­cide it in­her­it­ed with the ac­qui­si­tion. Bloomberg on Wednes­day re­port­ed a large pro­por­tion of about 125,000 US plain­tiffs who al­lege Roundup caus­es can­cer have ver­bal­ly agreed to a $10 bil­lion set­tle­ment to wrap up all le­gal claims against the weed­killer, cit­ing peo­ple fa­mil­iar with the mat­ter.

Mer­sana Ther­a­peu­tics $MRSN got a boost to­day af­ter shar­ing up­dat­ed Phase I ex­pan­sion da­ta on their lead drug XMT-1536. Their high­lights in­clude: “Among those pa­tients with high­er NaPi2b ex­pres­sion, two (2/14) pa­tients achieved a CR, and two (2/14) achieved a PR. Two (2/2) pa­tients with NaPi2b ex­pres­sion not yet de­ter­mined at the time of da­ta cut­off achieved con­firmed PRs. One (1/4) pa­tient with low­er NaPi2b ex­pres­sion (H-score of 90) achieved a con­firmed PR.”

Mer­sana adds that it ex­pects to de­fine the pa­tient se­lec­tion strat­e­gy based on the to­tal da­ta set from pa­tients treat­ed with XMT-1536. That was good for a 25% bump in the share price, though there are still plen­ty of ques­tions to be an­swered about com­pet­i­tive­ness and dura­bil­i­ty.

NICE, UK’s cost-ef­fec­tive­ness watch­dog, has worked out a deal with Roche to low­er its price for the com­pa­ny’s flag­ship check­point in­hibitor be­hind closed doors. The Swiss drug­mak­er’s Tecen­triq has now been rec­om­mend­ed for use in com­bi­na­tion with chemother­a­py — car­bo­platin and etopo­side — as a first-line treat­ment for ex­ten­sive-stage small cell lung can­cer (ES-SCLC) in the UK in a draft guid­ance. Around 2,400 peo­ple in Eng­land have ES-SCLC, of whom around 1,200 peo­ple will be el­i­gi­ble for treat­ment with Tecen­triq. The US ap­proved the com­bo in the same in­di­ca­tion last year.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to announce their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.

J&J re­leas­es PhI­II safe­ty blue­print for Covid-19 vac­cine tri­al. How does it stack up to Mod­er­na, Pfiz­er and As­traZeneca?

Along with the initiation of its Phase III Covid-19 vaccine study announced Wednesday morning, Johnson & Johnson also released its trial protocol, giving an inside look at how the company is conducting its late-stage research.

The move comes after the other three companies conducting Phase III’s in the US — Moderna, Pfizer and AstraZeneca — each disclosed their own trial blueprints within the last week. Though the release of such protocols is typically done after trials have been completed, drug developers had come under intense pressure after a brief safety scare in an AstraZeneca trial and amid growing concern of a politically motivated vaccine authorization.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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