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.

Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

It’s also likely to be a much less controversial post than his board position at Pfizer, which stirred criticism from Democratic presidential candidate Elizabeth Warren.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.