Cel­gene goes all-out on neu­rode­gen­er­a­tion and Alzheimer’s, trig­ger­ing block­buster deal with $150M in cash for Prothena

Af­ter qui­et­ly build­ing up an ex­pe­ri­enced team of in­ves­ti­ga­tors to tack­le neu­rode­gen­er­a­tion, Cel­gene has be­gun to ag­gres­sive­ly in-li­cense new drugs that can go af­ter Alzheimer’s and oth­er key dis­eases in the field.

Just days af­ter Cel­gene front­ed $50 mil­lion for a dis­cov­ery deal with Vi­vid­ion Ther­a­peu­tics that in­cludes neu­rode­gen­er­a­tion, the big biotech has now lined up op­tions on three pre­clin­i­cal neu­rode­gen­er­a­tion drug projects part­nered with Prothena. At the head of the list is a tau pro­gram, one of the key cul­prits that sci­en­tists be­lieve is close­ly linked with the de­vel­op­ment of Alzheimer’s.

Gene Kin­ney

Get­ting its busi­ness de­vel­op­ment team fo­cused on neu­rode­gen­er­a­tion, Cel­gene is pay­ing Prothena $100 mil­lion in cash plus an­oth­er $50 mil­lion for stock $PR­TA, with a pre­mi­um price of $42.57 baked in. In ad­di­tion, Prothena CEO Gene Kin­ney tells me that there’s a bit more than $2 bil­lion in mile­stones on the ta­ble. And $405 mil­lion of that is tied to op­tions on their drugs, when Cel­gene de­cides whether it will take over at the end of Phase I.

The deal terms were spelled out in an 8-K.

In­vestors wel­comed the news, dri­ving up Prothena’s shares by about 20%. The biotech’s shares have been lan­guish­ing in the wake of a short at­tack by Ker­ris­dale Cap­i­tal on their lead drug, with the dam­age ex­tend­ing to Neil Wood­ford’s in­vest­ment fund.

Prothena will now be re­spon­si­ble for ad­vanc­ing new ther­a­pies for tau in Alzheimer’s, ALS and one oth­er dis­ease they’re not dis­clos­ing for now in­to the clin­ic.

Richard Har­g­reaves

Bio­gen vet­er­an Richard Har­g­reaves jumped to Cel­gene to lead the neu­ro­sciences team. In a state­ment, he not­ed how Cel­gene is build­ing on its con­sid­er­able ex­per­tise in pro­tein re­search.

Our col­lab­o­ra­tion lever­ages each com­pa­ny’s core ex­per­tise in pro­tein home­osta­sis and pro­tein clear­ance to tar­get pro­teins that are the un­der­ly­ing cause of many neu­rode­gen­er­a­tive and or­phan dis­eases. The pro­grams we have cho­sen to col­lab­o­rate on have the po­ten­tial to pro­vide foun­da­tion­al as­sets from which we can build new ther­a­peu­tic ap­proach­es to these cur­rent­ly un­treat­able neu­ro­log­i­cal dis­or­ders.

“The team he’s build­ing brings a lot of val­ue to us,” says Kin­ney. So does their mon­ey.

Kin­ney adds: “This is the right way to start in­vest­ing in the fu­ture of the com­pa­ny.”

Mer­ck’s re­cent de­ci­sive fail­ure for a BACE ap­proach to clear­ing amy­loid be­ta has been shift­ing con­sid­er­able at­ten­tion in the field to tau, the oth­er tox­ic pro­tein at play. And there’s a grow­ing be­lief that it will take a com­bi­na­tion ap­proach to de­feat the dis­ease, which has de­fied every piv­otal try in more than a decade.

“We be­lieve tau and amy­loid be­ta are im­pli­cat­ed in Alzheimer’s dis­ease,” says Prothena CSO Wag­n­er Za­go. And Prothena be­lieves it has some in­sights on tau that could help Cel­gene lay the foun­da­tion for a suc­cess­ful pro­gram, among all the tau strate­gies out there now.

“We found some hot spots in the pro­tein which, tar­get­ed prop­er­ly, could af­fect cell to cell trans­mis­sion,” Za­go not­ed in an in­ter­view.

The oth­er known tar­get is the TDP-43 pro­tein. Prothena has been pick­ing out its top can­di­dates for in­hibit­ing tox­i­c­i­ty and cell-to-cell trans­mis­sion of mis­fold­ed TDP-43 species, which could play a key role in amytroph­ic lat­er­al scle­ro­sis.

A lit­tle more than two years ago, then Cel­gene CEO Bob Hug­in sig­naled his in­ter­est in the field. At a meet­ing with a group of re­porters at JP­Mor­gan, which in­clud­ed me, he said that any com­pa­ny that ex­pects to have a ma­jor po­si­tion in the in­dus­try a decade lat­er will al­most have to play a big role in de­vel­op­ing ther­a­pies for neu­rode­gen­er­a­tion.

Cel­gene, un­der Hug­in’s suc­ces­sor Mark Alles, is work­ing to make that hap­pen. And the time­line is get­ting short­er.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,600+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,600+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,600+ biopharma pros reading Endpoints daily — and it's free.

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. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,600+ biopharma pros reading Endpoints daily — and it's free.