Eli Lil­ly dish­es out first mile­stone pay­ment for Alzheimer's deal; ADC Ther­a­peu­tics, Viela Bio set terms for IPO

→ With oth­ers shy­ing away from the Alzheimer’s field af­ter the many clin­i­cal im­plo­sions and dis­as­ters, Eli Lil­ly is still chug­ging along with its $2 bil­lion deal with AC Im­mune — de­spite its share of BACE woes. AC Im­mune is set to re­ceive its first mile­stone pay­ment of CHF30 mil­lion, al­most a year af­ter the deal was inked. The com­pa­ny said that the pay­ment “is a recog­ni­tion of progress in the col­lab­o­ra­tion be­tween the two com­pa­nies and fol­lows ini­ti­a­tion in Ju­ly 2019 of the Phase 1 study of ACI-3024, a first-in-class in­ves­ti­ga­tion­al oral small mol­e­cule Tau Mor­phomer in de­vel­op­ment for treat­ment of Alzheimer’s dis­ease (AD) and oth­er neu­rode­gen­er­a­tive dis­or­ders.” A sec­ond mile­stone pay­ment of the same amount is sched­uled for Q1 of 2020.

→ Af­ter sign­ing a pact with Freenome and clos­ing a mon­ster $303 mil­lion E round in the last few months, ADC Ther­a­peu­tics set terms for its IPO on Mon­day. The Swiss com­pa­ny plans to of­fer 8.2 mil­lion shares at a price range of $23 to $26 to raise $200 mil­lion. In­sid­ers in­tend to pur­chase $115 mil­lion worth of shares in the of­fer­ing. At the mid­point of the pro­posed range, ADC would com­mand a mar­ket val­ue of $1.8 bil­lion.

As­traZeneca spin­out Viela Bio has closed in on the price range of its IPO, dis­clos­ing that it plans to of­fer 7.5 mil­lion shares be­tween $19 and $21 each. At the top of the range, the biotech will bring in $157.5 mil­lion to bankroll the de­vel­op­ment and com­mer­cial­iza­tion of its lead au­toim­mune drug, inebi­lizum­ab. The ful­ly di­lut­ed mar­ket val­ue (at the mid­point) could reach $1 bil­lion.

→ Is­raeli-based En­tera Bio has re­leased pos­i­tive da­ta for its oral parathy­roid hor­mone (PTH) drug Oral hPTH(1-34) from its Phase II study in pa­tients with hy­poparathy­roidism. Hav­ing test­ed four times dai­ly (QID) dos­ing in a pre­vi­ous study, the com­pa­ny want­ed to al­so com­pare twice dai­ly (BID) and three times dai­ly (TID) reg­i­mens and dose strengths.

“The re­sults showed that the largest changes in PD end­points were found with QID dos­ing, with mod­er­ate changes in PD end­points gen­er­al­ly found with BID and TID dos­ing,” stat­ed Pro­fes­sor Sofia Ish-Shalom, a prin­ci­pal in­ves­ti­ga­tor at the En­docrine Re­search Cen­ter at Lin Med­ical Cen­ter in Haifa, Is­rael. “In ad­di­tion, the QID dos­ing de­creased urine cal­ci­um over 24-hours, which in­di­cates that it may be able to re­duce uri­nary cal­ci­um in hy­poparathy­roid pa­tients with hy­per­cal­ci­uria dur­ing long-term treat­ment.”

→ In June, teplizum­ab (PRV-031) — which was re­ject­ed by Eli Lil­ly 9 years ago, but picked up by Proven­tion Bio — was shown to de­lay type 1 di­a­betes. Now, Proven­tion an­nounced that “based on writ­ten com­mu­ni­ca­tions from the FDA and the FDA’s des­ig­na­tion of PRV-031 as a break­through ther­a­py, the Com­pa­ny be­lieves that ex­ist­ing clin­i­cal and non-clin­i­cal da­ta for PRV-031 will be suf­fi­cient to sup­port a Bi­o­log­ics Li­cense Ap­pli­ca­tion (BLA) sub­mis­sion for PRV-031 in the fourth quar­ter of 2020 for the at-risk in­di­ca­tion.” The New Jer­sey-based com­pa­ny ex­pects to meet with the FDA in the fourth quar­ter of 2019 to dis­cuss this ex­pe­dit­ed plan.

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. 

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.

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