Red­Hill's an­tibi­ot­ic Tal­i­cia edges clos­er to ap­proval, af­ter sec­ond suc­cess­ful Phase III study

As one of the few com­pa­nies fo­cus­ing on tack­ling the bur­geon­ing threat of su­per­bugs, Is­rael’s Red­Hill Bio­phar­ma $RDHL is mak­ing strides. On Mon­day, it said its ex­per­i­men­tal drug Tal­i­cia was suc­cess­ful in erad­i­cat­ing the H. py­lori in­fec­tion, meet­ing the main goal of a sec­ond Phase III study.

The da­ta are com­pelling enough for the com­pa­ny to sub­mit an ap­pli­ca­tion to mar­ket the drug in 2019 for the es­ti­mat­ed 2.5 mil­lion pa­tients treat­ed for the in­fec­tion each year in the Unit­ed States.

In the 455-pa­tient tri­al, pa­tients were ei­ther giv­en Tal­i­cia or the ac­tive com­para­tor, an amox­i­cillin and omepra­zole reg­i­men. Da­ta showed an 84% erad­i­ca­tion of H. py­lori in­fec­tion with Tal­i­cia ver­sus 58% in those who got the oth­er reg­i­men.

Tri­al da­ta al­so demon­strat­ed pa­tients ex­pe­ri­enced a high re­sis­tance to the stan­dard-of-care reg­i­men — con­sis­tent with the falling ef­fi­ca­cy of such ther­a­pies, which typ­i­cal­ly con­sist of the an­tibi­otics clar­ithromycin and metron­ida­zole, the com­pa­ny said.

Tal­i­cia is an oral cap­sule com­pris­ing ri­fabutin, amox­i­cillin and a pro­ton pump in­hibitor, omepra­zole.

About two-thirds of the world’s pop­u­la­tion has H. py­lori in their bod­ies. But for most, it doesn’t cause ul­cers or any oth­er symp­toms, though is con­sid­ered the strongest risk fac­tor for the de­vel­op­ment of gas­tric can­cer.

The grow­ing scourge of an­tibi­ot­ic re­sis­tance is a sig­nif­i­cant prob­lem that should ar­guably en­tice a swarm of R&D dol­lars, but these drugs com­mand rel­a­tive­ly cheap prices and don’t last as long as, say, can­cer drugs, which has in­cen­tivized Big Phar­ma to fo­cus their at­ten­tion else­where. How­ev­er, a hand­ful of small and big names are keep­ing the R&D en­gine hot. Tel Aviv’s Red­hill is one of them, and the FDA has re­ward­ed their dogged fo­cus by giv­ing Tal­i­cia all the bells and whis­tles to has­ten its path to­ward ap­proval.

The drug was grant­ed the Qual­i­fied In­fec­tious Dis­ease Prod­uct des­ig­na­tion as well as fast-track sta­tus by the reg­u­la­tor, in­clud­ing el­i­gi­bil­i­ty for six-month pri­or­i­ty re­view and eight years of US mar­ket ex­clu­siv­i­ty. The prod­uct is al­so pro­tect­ed un­til at least 2034, un­der var­i­ous US patents.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Boehringer bags Swiss can­cer biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.

Jonathan Symonds [via HSBC]

GSK to tap Jonathan Symonds as chair­man, lever­ag­ing Big Phar­ma ex­pe­ri­ence for con­sumer biz deal

Six months into its search for a new board chairman, GlaxoSmithKline has apparently found the perfect candidate in a seasoned executive groomed at AstraZeneca and Novartis. Jonathan Symonds is in the final stages of being appointed, Bloomberg reports.

In January Sir Philip Hampton announced his intention to step down and make way for a new leader to oversee the consumer health joint venture GSK is setting up with Pfizer. The deal — announced a month prior — would spin out the unit formerly headed by GSK CEO Emma Walmsley and merge it with the equivalent division at Pfizer to create a new entity to be listed separately.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

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