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.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.