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:

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.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.