No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Nev­er un­der­es­ti­mate the pow­er of a good show­ing at a sci­en­tif­ic con­fer­ence.

In a pre­sen­ta­tion late last year, the re­searchers at Pli­ant Ther­a­peu­tics launched a se­ries of dis­cus­sions about the pre­clin­i­cal da­ta they were pulling to­geth­er around their work on their small-mol­e­cule in­te­grin in­hibitor aimed at trans­form­ing growth fac­tor be­ta, or TGF-β, a key path­way in­volved in fi­bro­sis.

And they got some se­ri­ous at­ten­tion for the work.

“We got in­ter­est from phar­ma part­ners and at the end No­var­tis ba­si­cal­ly made it,” says Pli­ant CEO Bernard Coulie.

Bernard Coulie Pli­ant

Mak­ing it, in this case, in­volves an $80 mil­lion check that No­var­tis sent over for an up­front and un­spec­i­fied eq­ui­ty stake in the com­pa­ny, along with a com­mit­ment to cov­er the R&D costs as Pli­ant takes a col­lab­o­ra­tion project on PLN-1474 through Phase I. The drug is an in­hibitor of in­te­grin αVβ1 for fi­bro­sis re­lat­ed to NASH. And the phar­ma gi­ant gets dibs on 3 oth­er pro­grams.

That’s a con­sid­er­able amount of cash for a pre­clin­i­cal deal, un­der­scor­ing the biotech’s boast that an in­dus­try leader with a big ap­petite for pipeline projects thinks it’s well-po­si­tioned to de­liv­er in a very chal­leng­ing field.

Up un­til a few weeks ago, Bio­gen had been out in front of Pli­ant’s lead pro­gram, a Phase II pro­gram for id­io­path­ic pul­monary fi­bro­sis, with a fol­low-up in the clin­ic on and pri­ma­ry scle­ros­ing cholan­gi­tis.

Much of their sci­ence is based on the lab work of UCSF’s sci­en­tif­ic co-founder Dean Shep­pard, who al­so helped in­spire a ri­val pro­gram at Stromedix, a Michael Gilman start­up that was reeled back in at Bio­gen on­ly to fail re­cent­ly.

Coulie be­lieves that the death of the Bio­gen drug was like­ly due to the an­ti­body that was be­ing used — as op­posed to the small mol­e­cule ap­proach they have. He says it’s like­ly that the an­ti­body “it­self may ac­ti­vate the im­mune sys­tem.”

But it’s hard get­ting an ac­cu­rate read at a dis­tance.

Jay Brad­ner No­var­tis

Coulie adds that the No­var­tis In­sti­tutes for Bio­Med­ical Re­search un­der Jay Brad­ner was drawn to their ap­proach in part be­cause of a close re­la­tion­ship the South San Fran­cis­co based biotech has with Stan­ford and UCSF, which pro­vide hu­man tis­sue from pa­tients with ad­vanced cas­es of the dis­ease — a core in­gre­di­ent for the kind of pre­clin­i­cal tis­sue re­search they have cen­tered on.

“That was a key fac­tor,” says the CEO. “The oth­er was that No­var­tis and oth­ers be­lieve in the in­te­grin tar­gets as a po­ten­tial tar­get for fi­bro­sis.”

With the No­var­tis cash, Pli­ant has now raised slight­ly more than $200 mil­lion to back the work of the 59 staffers at the com­pa­ny. That pro­vides some op­tions on next steps that Coulie and the ex­ec­u­tive team can con­sid­er as they ma­neu­ver clos­er to the point where they can start of­fer­ing hu­man da­ta on their work.

No­var­tis will be right by their side

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

Social image: UCB