Dicer­na es­ca­lates war with Al­ny­lam over RNAi se­crets, claim­ing its ri­val wants a mo­nop­oly

Al­ny­lam made quite a splash in ear­ly 2014 when it an­nounced that it had ac­quired Mer­ck’s RNAi sub­sidiary Sir­na for $175 mil­lion. The deal to ac­quire Mer­ck’s group, which the phar­ma gi­ant had bagged in a $1.1 bil­lion buy­out in 2006, in­clud­ed some valu­able de­liv­ery tech that Al­ny­lam thought would ben­e­fit its GalNAc plat­form.

But there was a fly in that oint­ment that would dri­ve Al­ny­lam $AL­NY to sue RNAi ri­val Dicer­na $DR­NA 18 months lat­er in state court for al­leged­ly mis­ap­pro­pri­at­ing trade se­crets that dealt with that GalNAc tech. Ac­cord­ing to Al­ny­lam, Dicer­na had im­prop­er­ly swept up tech Al­ny­lam paid for when it hired a group of sci­en­tists oust­ed from Mer­ck af­ter the phar­ma gi­ant had de­cid­ed to shut it all down and of­fload the work. Af­ter a long se­ries of le­gal moves, that case is sup­posed to move for­ward to a tri­al in the spring of 2018.

Dicer­na, though, says it’s the vic­tim now. Al­ny­lam’s suit, the biotech says in a new law­suit filed in fed­er­al court in Boston this week, is noth­ing but a sham aimed at block­ing a ri­val pro­gram from beat­ing Al­ny­lam in the clin­ic, chill­ing po­ten­tial part­ner­ships while grab­bing a mo­nop­oly for it­self in the RNAi space. And Dicer­na wants a fed­er­al judge to put a stop to it un­der fed­er­al an­titrust laws in the Sher­man Act.

John Maraganore, Al­ny­lam

The crux of Dicer­na’s mo­nop­oly claims spot­lights an Achilles heel in trade se­crets that any bio­phar­ma ex­ec will want to pay close at­ten­tion to. It al­so pro­vides some com­pelling anec­dotes about how eas­i­ly re­search leaked out of Mer­ck af­ter the com­pa­ny de­cid­ed to punt their R&D flop. Dicer­na is claim­ing that Mer­ck ex­ec­u­tives prac­ti­cal­ly did every­thing but help car­ry suit­cas­es loaded with re­search out the door as they helped line up new jobs for the de­part­ing Sir­na staffers. And their case de­tails nu­mer­ous in­stances of just how help­ful they could be.

“Dur­ing the fi­nal months lead­ing up to the sale of its RNAi pro­gram Mer­ck al­lowed its ter­mi­nat­ed sci­en­tists to re­move in­for­ma­tion with­out any ef­fec­tive check on their ac­tiv­i­ties,” Dicer­na claims. There were no ex­it in­ter­views. No mon­i­tor­ing of the de­part­ing re­searchers. No ef­fort to pre­vent down­load­ing or cor­ral doc­u­ments.

“Mer­ck man­age­ment af­fir­ma­tive­ly en­cour­aged the ter­mi­nat­ed sci­en­tists to take slides and oth­er in­for­ma­tion with them” to help land new jobs. They even glad­ly told one of Dicer­na’s new hires to take in­fo need­ed for pub­li­ca­tions he was work­ing on. “In­deed, even af­ter Al­ny­lam sent a Jan­u­ary 26 let­ter to Dicer­na de­mand­ing the re­turn of al­leged trade se­crets, at least one Mer­ck em­ploy­ee con­tin­ued to send doc­u­ments to that sci­en­tist with in­for­ma­tion re­lat­ing to work he was do­ing on a man­u­script they hoped to pub­lish.”

Legal­ly, in or­der to claim that some­one mis­ap­pro­pri­at­ed trade se­crets, you have to show that the “se­crets” were prop­er­ly guard­ed. If you don’t take “rea­son­able” ef­forts to pro­tect it, it can’t be mis­ap­pro­pri­at­ed. In oth­er words, if you don’t guard the door, you can’t say any­one walk­ing out with your da­ta was steal­ing it. Al­ny­lam even ac­cused one of Dicer­na’s sci­en­tists with rolling out in­for­ma­tion in suit­cas­es with­out any­one at Mer­ck try­ing to stop him.

So why not just fight it out in state court?

Be­cause Dicer­na claims that Al­ny­lam’s re­al in­tent is to keep it un­der a cloud, chill­ing any part­ner­ships, li­cens­ing deals and al­liances which are the life blood of biotech. Two po­ten­tial part­ners walked away, Dicer­na’s suit claims, be­cause of the lit­i­ga­tion. At least one wouldn’t even talk to the com­pa­ny be­cause of the case.

That gives the big­ger Al­ny­lam an un­fair ad­van­tage, the suit al­leges, as they each try to steer ri­val pro­grams for pri­ma­ry hy­per­ox­aluria type 1 (PH1) through the clin­ic.

“By im­ped­ing Dicer­na’s com­pet­i­tive ef­forts, Al­ny­lam will be able to mo­nop­o­lize the mar­ket for the de­vel­op­ment (of) RNAi-based treat­ment of PH1,” Dicer­na says. That will stop their broad­er based pro­gram that in­cludes PH2 and PH3. Dicer­na wants a fed­er­al judge to stop the mo­nop­oly move rather than leave pa­tients with one or no choice, forc­ing them to pay more.

Here is the full doc­u­ment:

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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