From ze­ro to hero: En­do­cyte’s lit­tle deal a year ago spurred a come­back capped by $2.1B No­var­tis buy­out

A year ago, with its stock in the toi­let af­ter its lead drug flopped in Phase III, forc­ing a re­struc­tur­ing, new En­do­cyte CEO Mike Sher­man said every­thing you would ex­pect a biotech chief to say af­ter com­plet­ing a small li­cens­ing deal for a new lead drug. The $12 mil­lion up­front deal with ABX was trans­for­ma­tion­al, he boast­ed to re­porters. It was a block­buster head­ed to a multi­bil­lion dol­lar mar­ket. 

Mike Sher­man

Every­thing was great. (Yeah, sure.)

But Sher­man proved to skep­tics to­day that he was right to be op­ti­mistic about big things to come.

Thurs­day morn­ing No­var­tis stepped in and bought the com­pa­ny for $2.1 bil­lion just so it could get its hands on that drug. That’s a mod­est-sized bolt-on for the likes of No­var­tis, but it’s the kind of block­buster mon­ey that in­vestors in lit­tle biotechs dream of.

No­var­tis is buy­ing En­do­cyte $ECYT out for $24 a share, a 54% pre­mi­um over Wednes­day’s close. The price is 94% high­er than it was just be­fore their ABX deal closed last Sep­tem­ber.

The drug is Lu-PS­MA-617, a ra­dioiso­tope tar­get­ing prostate-spe­cif­ic mem­brane anti­gen, or PS­MA, com­mon­ly found in metasta­t­ic prostate can­cer. En­do­cyte hus­tled it straight in­to Phase III.

Liz Bar­rett

The seeds of this buy­out go back to just a few weeks af­ter En­do­cyte did its li­cens­ing deal. No­var­tis bought out France’s Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions in late Oc­to­ber, 2017, for $3.9 bil­lion. That ac­qui­si­tion gave the phar­ma gi­ant Lu­tathera and its plat­form tech on ra­dio­phar­ma­ceu­ti­cals. 

This new deal gives No­var­tis a late-stage as­set at an eco­nom­i­cal price for its new group, falling in­to its sweet spot of a $2 bil­lion to $5 bil­lion snap-on deal.

They’re buy­ing a drug that reg­is­tered a pro­gres­sion-free sur­vival rate of 7.6 months among PS­MA-pos­i­tive pa­tients, with one co­hort hit­ting an over­all sur­vival rate of 13.5 months — all sta­tis­ti­cal­ly sig­nif­i­cant. A few weeks ago an oblig­ing FDA OK’d ra­di­ograph­ic pro­gres­sion-free sur­vival as an al­ter­na­tive pri­ma­ry end­point to OS in the Phase III tri­al.

Liz Bar­rett, No­var­tis’ on­col­o­gy chief, did the hon­ors in herald­ing the deal.

To­day’s an­nounce­ment about the pro­posed ac­qui­si­tion of En­do­cyte builds on our grow­ing ca­pa­bil­i­ty in ra­dio­phar­ma­ceu­ti­cals, which is ex­pect­ed to be an in­creas­ing­ly im­por­tant treat­ment op­tion for pa­tients and a key growth dri­ver for our busi­ness. We are al­so ex­cit­ed about the op­por­tu­ni­ty to break in­to the prostate can­cer are­na with a near-term prod­uct that has the po­ten­tial to make a mean­ing­ful im­pact for pa­tients in great need of more op­tions.

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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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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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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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.