Mer­ck touts Phase III da­ta for an­tibac­te­r­i­al Re­car­brio; Sanofi to ax 200 jobs in Japan — re­port

→ Ac­cord­ing to an anony­mous source who re­port­ed to Reuters, French drug­mak­er Sanofi plans to ax 200 jobs in Japan across sales, reg­u­la­to­ry af­fairs and op­er­a­tions. This adds to the on­go­ing plans of re­or­ga­ni­za­tion by re­search chief John Reed. Back in June, the com­pa­ny an­nounced it would be plac­ing 466 jobs in France and Ger­many on the chop­ping block and trim­ming of their staff in the US by of­fer­ing em­ploy­ees an “ear­ly ex­it”. A Sanofi rep­re­sen­ta­tive added, “Sanofi Japan plans to im­ple­ment a vol­un­tary re­tire­ment pro­gramme in or­der to adapt to the ex­ter­nal en­vi­ron­ment changes and to trans­form our busi­ness mod­els to con­tin­ue our growth.”

In Ju­ly, Mer­ck‘s Re­car­brio had se­cured FDA ap­proval for the treat­ment of com­pli­cat­ed uri­nary tract and in­tra-ab­dom­i­nal in­fec­tions. Now the com­pa­ny has an­nounced that the piv­otal Phase III RE­STORE-IMI II tri­al — which was in­ves­ti­gat­ing the ef­fi­ca­cy and safe­ty of the an­tibac­te­r­i­al for use in adult pa­tients with hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia (HABP/VABP) — met its pri­ma­ry end­point. “Re­sults showed that Re­car­brio met both pri­ma­ry and key sec­ondary end­points of sta­tis­ti­cal non-in­fe­ri­or­i­ty com­pared to piperacillin/tazobac­tam in Day 28 all-cause mor­tal­i­ty and clin­i­cal re­sponse at ear­ly fol­low up, re­spec­tive­ly, in the mod­i­fied in­tent-to-treat (MITT) pop­u­la­tion. Rates of ad­verse events ob­served in the tri­al were sim­i­lar in both groups.” The com­pa­ny plans to present full da­ta from the tri­al in 2020.

→ Some of Mallinck­rodt‘s opi­oid woes are com­ing to an end. The com­pa­ny has reached a de­fin­i­tive set­tle­ment agree­ment and re­lease with two coun­ties in Ohio in con­nec­tion to cur­rent pend­ing law­suits in the US Dis­trict Court for the North­ern Dis­trict of Ohio. The com­pa­ny says that the set­tle­ment ful­ly re­solves the Track 1 cas­es against it, cur­rent­ly sched­uled to go to tri­al in Oc­to­ber. “Un­der the agree­ment, the com­pa­ny will pay $24 mil­lion in cash and pro­vide $6 mil­lion in gener­ic prod­ucts, in­clud­ing ad­dic­tion treat­ment prod­ucts. It al­so will pro­vide a $500,000 pay­ment in two years in recog­ni­tion of the coun­ties’ time and ex­pens­es.”

→ Swiss-based Cre­op­tix has raised CHF 8 mil­lion in a Se­ries C fi­nanc­ing. The round was led by Swiss­canto In­vest by Zürcher Kan­ton­al­bank and joined by Wa­ters Cor­po­ra­tion in ad­di­tion to ex­ist­ing pri­vate in­vestors. In ad­di­tion, Robert Schi­er — who hails from Swiss­canto In­vest — has joined the com­pa­ny’s board of di­rec­tors. With this round, the com­pa­ny has raised more than CHF 15 mil­lion since 2013. The fi­nanc­ing will be used to­wards strength­ing the com­pa­ny’s op­er­a­tions in Eu­rope and the US.

→ Af­ter re­cent­ly do­mes­ti­cal­ly launch­ing their SGLT2 in­hibitor Re­mogliflozin in com­bi­na­tion with met­formin, In­dia’s Glen­mark has se­cured ap­proval from Rus­sia’s health reg­u­la­tor to mar­ket Mon­lezir (Le­v­o­ce­t­i­rizine Di­hy­drochlo­ride 5mg + Mon­telukast Sodi­um 10mg) film­coat­ed tablets for the treat­ment of sea­son­al and peren­ni­al al­ler­gic rhini­tis in pa­tients above 15 years of age. The com­pa­ny said that the drug is ex­pect­ed to be avail­able in the Russ­ian mar­ket in Q3 FY 2019-20.

→ Ox­ford, UK-based re­search com­pa­ny Arc­toris — which bills it­self as an au­to­mat­ed drug dis­cov­ery plat­form — has closed a seed fund­ing round of £3.2 mil­lion. The fund­ing will be used to­wards the com­pa­ny’s com­mer­cial op­er­a­tions and ser­vice port­fo­lio — which they say will en­able the com­pa­ny’s cus­tomers to “rapid­ly and ac­cu­rate­ly achieve drug dis­cov­ery mile­stones from tar­get iden­ti­fi­ca­tion to can­di­date char­ac­ter­i­sa­tion, as well as dataset gen­er­a­tion for ar­ti­fi­cial in­tel­li­gence (AI/ML) mod­el val­i­da­tion and train­ing.”

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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