No­var­tis joins forces with Al­ler­gan, push­ing a NASH com­bo in­to late-stage de­vel­op­ment

Brent Saun­ders speak­ing at an End­points News event on Jan 10, 2017 End­points News

Look­ing to leapfrog some in­tense com­pe­ti­tion to field new drugs for NASH and fat­ty liv­er dis­ease, phar­ma gi­ant No­var­tis has struck a deal to part­ner with Al­ler­gan on a new com­bo ap­proach that will start out in a Phase IIb tri­al.

No­var­tis is com­bin­ing an FXR ag­o­nist with Al­ler­gan’s ceni­crivi­roc — CVC — for the treat­ment of non-al­co­holic steato­hep­ati­tis. And they’re keep­ing the num­bers side of the arrange­ment un­der wraps.

No­var­tis be­lieves that Al­ler­gan’s CVC — which tack­les CCR2 and CCR5, a pair of in­flam­ma­to­ry chemokine re­cep­tors — is the kind of drug that will fig­ure promi­nent­ly in new cock­tails for NASH, a ma­jor mar­ket op­por­tu­ni­ty that has at­tract­ed a line­up of ri­vals like Gilead, In­ter­cept and Shire.

The deal with No­var­tis marks a quick val­i­da­tion of Al­ler­gan CEO Brent Saun­ders’ de­ci­sion to pay a huge pre­mi­um to bag To­bi­ra last fall in a deal worth up to $1.7 bil­lion — in­clud­ing a cash up­front worth 6 times the biotech’s fi­nal share price. To­bi­ra’s stock had been bat­tered by the drug’s fail­ure in a Phase IIb tri­al for NASH last sum­mer, but in­ves­ti­ga­tors gath­ered pos­i­tive da­ta for a key sec­ondary end­point that was moved up to the pri­ma­ry for a prospec­tive Phase III tri­al.

Al­ler­gan has been build­ing a port­fo­lio of new drugs for NASH, adding pre­clin­i­cal FXR ag­o­nists in a deal to ac­quire Akar­na on the same day it bagged To­bi­ra. No­var­tis’ FXR ag­o­nist is in a Phase II study, though, mov­ing the com­bo in­to a much more ad­vanced po­si­tion.

No­var­tis, mean­while, has al­so set its sights on be­com­ing a late-stage play­er in the field. The phar­ma gi­ant struck a deal to col­lab­o­rate with Cona­tus on its oral pan-cas­pase in­hibitor em­ri­c­as­an for NASH last De­cem­ber.

NASH and liv­er fi­bro­sis have be­come a ma­jor tar­get as its preva­lence spreads rapid­ly in the US and the world.

No­var­tis likes to work qui­et­ly ahead of Phase III but car­ry a big check­book for any ex­per­i­men­tal prod­ucts it may need along the way. In this case, the Big Phar­ma op­er­a­tion is go­ing af­ter a mega­mar­ket some ex­cit­ed an­a­lysts have pegged at a po­ten­tial $35 bil­lion. To get there, though, de­vel­op­ers will need to find eas­i­er ways to di­ag­nose the dis­ease to iden­ti­fy pa­tients, many of whom do not nec­es­sar­i­ly face an im­me­di­ate health threat.

Vas­ant Narasimhan No­var­tis

“Our clin­i­cal col­lab­o­ra­tion with Al­ler­gan ex­pands our de­vel­op­ment pro­grams for NASH, bring­ing to­geth­er sci­ence and ex­per­tise to in­ves­ti­gate a po­ten­tial new com­bi­na­tion ther­a­py in an ef­fort to make a pos­i­tive change for peo­ple liv­ing with this con­di­tion,” said Vas Narasimhan, No­var­tis’ CMO and head of drug de­vel­op­ment.  “We be­lieve that col­lab­o­ra­tion is key to de­vel­op­ing the best pos­si­ble treat­ments that are ur­gent­ly need­ed for NASH pa­tients.”

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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Sangamo CEO Sandy Macrae

Pa­tient #9 has been a con­cern, but Sang­amo and Pfiz­er are bull­ish about win­ning the marathon he­mo­phil­ia A gene ther­a­py race

Patient number 9 has given Sangamo and its partners at Pfizer some heart palpitations in their high profile hemophilia A gene therapy program.

After watching his Factor VIII level rise following treatment like the rest, the crucial efficacy gauge they track saw a sudden and significant plunge. At week 13, the FVIII level had dropped below normal. Then it began to rise again.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Vas Narasimhan, Getty Images

No­var­tis CEO Vas Narasimhan's R&D up­date spot­lights next wave of drug stars as well as late-stage fa­vorites

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future.

Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis CEO Vas Narasimhan — who’s done a slate of acquisitions topped by the recent $9.7 billion MedCo buyout — tapped the top emerging drugs as:

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Jeff Jonas, Sage

UP­DAT­ED: Sage's star ex­per­i­men­tal de­pres­sion drug fails the cru­cial MOUN­TAIN study — shares crash

Sage Therapeutics’ crucial MOUNTAIN study for Sage-217 has failed, setting the stage for a quick and ugly investor backlash.

Widely viewed by analysts as the critical clinical study $SAGE needed to win on major depression, researchers say the drug failed to beat out a placebo at day 15, falling well short of the mark for statistical significance on the primary endpoint. And investors reacted with alacrity, fleeing the stock and gutting the price with a 60% instantaneous drop — erasing about $4.6 billion in market cap in an instant.

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