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:

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Yung Chyung, Scholar Rock CMO (Business Wire)

A dark horse en­trant in­to the spinal mus­cu­lar at­ro­phy field dou­bles its val­ue on some PhII da­ta

The last four years have seen a sudden explosion in treatments for spinal muscular atrophy, a neurodegenerative condition that once led patients — often young ones — with a grim prognosis and no options. The prognosis still isn’t rosy, but now there are three FDA-approved options, enough to make the choice of one difficult.

Now a fourth potential option has entered the mix. Today, Scholar Rock announced the results from a proof-of-concept testing their SMA drug by itself and in combination with Ionis’ Spinraza, showing that all patient cohorts improved on standard scales used for measuring motor function in people with SMA.

UP­DAT­ED: Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.