Dai­ichi Sankyo re­port­ed­ly sell­ing OTC unit for $900M in piv­ot to on­col­o­gy — but com­pa­ny says it's 'in­cor­rec­t'

Dai­ichi Sankyo has coun­tered a news re­port that it’s look­ing to sell its over-the-counter sub­sidiary for about $900 mil­lion, once again dis­pelling spec­u­la­tion that’s been wide­ly cir­cu­lat­ed as the drug­mak­er con­sol­i­dates op­er­a­tions around its grow­ing on­col­o­gy unit.

Jo­ji Nakaya­ma

Japan­ese pub­li­ca­tion Nikkei Busi­ness first re­port­ed that Dai­ichi Sankyo is in talks with sev­er­al com­pa­nies to sell Dai­ichi Sankyo Health­care, which sells pain patch­es, cold med­i­cines, nu­tri­tion­al sup­ple­ments and the like. In March, un­named sources told Reuters that the com­pa­ny had hired JP Mor­gan to ad­vise on a po­ten­tial deal.

With­in hours, the Tokyo head­quar­ters of­fered a brief re­sponse:

Al­though Dai­ichi Sankyo is con­stant­ly ex­am­in­ing the po­ten­tial for a va­ri­ety of strate­gic de­vel­op­ments with the aim of sus­tain­able busi­ness growth, this re­port­ing is not cor­rect.

The de­nial treads the same lines that Dai­ichi chair­man and CEO Jo­ji Nakaya­ma adopt­ed last month in an earn­ings call when an an­a­lyst flat out asked if he is con­sid­er­ing the sales of the unit.

“I have been say­ing that we will sell our non-core as­sets and will fo­cus on core busi­ness­es,” he said. Af­ter elab­o­rat­ing on how they might re­or­ga­nize the non-core busi­ness if the core gets stronger, he con­clud­ed: “The more we be­come fo­cused, the more things there will be for us to con­sid­er in the fu­ture. How­ev­er, we have not de­cid­ed any­thing as to what you men­tioned.”

Hav­ing made a for­tune and a name for it­self on the blood pres­sure drug Benicar (Olme­sar­tan), Dai­ichi Sankyo is now fac­ing a big rev­enue drop from patent loss and has been bet­ting on can­cer as its next big break.

Its bag is a mixed one so far: While an an­ti­body-drug con­ju­gate tar­get­ing HER2 ex­press­ing can­cers has the en­dorse­ment of As­traZeneca in the form of a mul­ti-bil­lion pact, FDA ex­perts shot down its pitch for an acute myeloid leukemia drug days ago de­spite giv­ing thumbs up on an­oth­er rare tu­mor treat­ment.

Kristof­fer Trip­plaar for Sipa USA. AP

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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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

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.

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.

Covid-19 roundup: EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund; Bei­jing ar­rests ex-Bio­gen staffer who flew while in­fect­ed

For months now, the US government has doled out unprecedented grants to vaccine developers in hopes of speeding the completion of a Covid-19 candidate, even if that meant putting hundreds of millions or billions behind efforts that ultimately failed. Now, the European Union may do the same.

The EU is planning to use a $2.7 billion rainy day fund to make advance purchases of vaccine candidates, Reuters reports. The news comes a day after the Trump Administration reportedly settled on the five finalists for its Operation Warp Speed, all of whom will get significant funding and other US assistance to finish testing and scale up their vaccine candidates.

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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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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.

New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.

The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic.

Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing.