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:

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.