(An­oth­er) ac­tivist at­tack on Alex­ion, as Paul Singer-found­ed hedge fund calls for biotech to sell it­self

In De­cem­ber, Alex­ion was forced to is­sue a high­ly un­usu­al state­ment: No, they told in­vestors, the com­pa­ny is not for sale and, no, they have not re­ceived any of­fers.

“It is high­ly un­usu­al, if not un­prece­dent­ed, for a bio­phar­ma­ceu­ti­cal com­pa­ny of our size and ma­tu­ri­ty to proac­tive­ly launch a sale process,” they wrote. “We do not be­lieve this ap­proach is the best path for dri­ving share­hold­er val­ue.”

Alex­ion’s lead­er­ship was writ­ing in re­sponse to an in­ter­nal ac­tivist at­tack from El­liott Ad­vi­sors, a hedge fund that has pres­sured the board since it took a stake in the biotech in 2017. Now El­liott is back and, for the first time, call­ing pub­licly for an out­right sale of the com­pa­ny.

The Paul Singer-led hedge fund, known for its com­pa­ny-warp­ing at­tacks in a num­ber of in­dus­tries, took par­tic­u­lar is­sue with Alex­ion’s $1.4 bil­lion ac­qui­si­tion of the blood dis­or­der biotech Por­to­la, a move that was wide­ly panned by in­vestors and led to an im­me­di­ate $1.7 bil­lion shave off the mar­ket val­ue, per El­liott’s cal­cu­la­tions. El­liott said the move was em­blem­at­ic of the mis­man­age­ment that had led to their pre­vi­ous, pri­vate bat­ter­ing of crit­i­cism at the end of 2019.

“Near­ly half a year lat­er, with height­ened ur­gency amidst a pub­lic health cri­sis and con­sid­er­able eco­nom­ic tur­moil, the mar­ket con­tin­ues to ren­der a de­ci­sive ver­dict for Alex­ion’s “go-it-alone, trust-us” ap­proach,” they wrote in a pub­lic let­ter to the board of di­rec­tors.  “The an­nounce­ment of your ac­qui­si­tion of Por­to­la – and the harsh neg­a­tive mar­ket re­ac­tion that fol­lowed – of­fers the lat­est ev­i­dence in sup­port of our view that the Board is tak­ing Alex­ion in the wrong di­rec­tion, and that the Com­pa­ny’s cur­rent strat­e­gy is un­like­ly to re­store the mar­ket’s per­cep­tions of Alex­ion’s at­trac­tive­ness and unique­ness.”

With Alex­ion hold­ing a mar­ket val­ue of over $22 bil­lion, a buy­out would like­ly be one of the largest biotech ac­qui­si­tions in re­cent mem­o­ry, and it’s un­clear who would put up the cash. Al­though the Con­necti­cut-based com­pa­ny has gen­er­at­ed con­sis­tent rev­enue by charg­ing over half-a-mil­lion dol­lars per year for its blood dis­or­der drug Soliris, patent pro­tec­tion on the drug ex­pired in 2017. The com­pa­ny’s strat­e­gy has con­sist­ed large­ly of switch­ing over pa­tients to the more con­ve­nient and sim­i­lar­ly priced Ul­tomiris, but ri­vals — such as a new drug from Apel­lis and an Am­gen biosim­i­lar — are emerg­ing.

At JP Mor­gan, short­ly af­ter the last El­liott at­tack, Alex­ion pre­dict­ed it would treat four times as many neu­ro­log­i­cal pa­tients with its drugs — a claim that raised an­a­lysts’ eyes, who won­dered where the pa­tients would come. Alex­ion is still await­ing 2021 read­outs on ALS and oth­er rare dis­or­ders.

In a note to in­vestors, SVB Leerink’s Ge­of­frey Porges echoed El­liott’s con­cerns. The com­pa­ny has ex­e­cut­ed well on its stat­ed strat­e­gy, he wrote, but its ac­qui­si­tions have been ques­tion­able and the stock has cu­mu­la­tive­ly un­der­per­formed.

“We agree that the most im­me­di­ate and ob­vi­ous val­ue cre­ation op­por­tu­ni­ty would be the sale of the com­pa­ny to a larg­er ac­quir­er, and con­cur that Alex­ion’s port­fo­lio would be a good fit with a num­ber of much larg­er com­pa­nies that have sig­nif­i­cant in­ter­ests in rare dis­ease treat­ments al­ready,” he said.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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No­var­tis says Kym­ri­ah reach­es pri­ma­ry end­point in new PhII, al­though num­bers still to come

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

Ab­b­Vie shrugs off $134M cash deals, quit­ting a neu­ro R&D pact with Voy­ager Ther­a­peu­tics on vec­tor­ized an­ti­body treat­ments

It’s the end of the road for Voyager Therapeutics’ collaboration with AbbVie on tau and alpha-synuclein vectorized antibody development.

In two deals spanning the last two years, AbbVie dropped more than $134 million upfront for Voyager’s preclinical R&D of vectorized antibody treatments for diseases like Alzheimer’s and Parkinson’s. But Voyager says AbbVie is walking away now, without offering an explanation for why.

Mer­ck scoops up a PhII J&J dis­card in a bar­gain-base­ment deal. And this time they’re shoot­ing at NASH

When J&J turned to South Korea’s Hanmi for a GLP-1/glucagon dual receptor agonist obesity drug, the pharma giant paid $105 million in a cash upfront for the licensing rights and plotted a big clinical trial program to test it. A year ago, like a few of Hanmi’s big partners, J&J reviewed their trial data and walked away, handing it back.

Now Merck is stepping up to grab it for their NASH pipeline — and they got it a lot cheaper than J&J.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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