FDA (Image: AP)

As re­sis­tance to stan­dard an­tibi­otics grows, Red­Hill's H. py­lori reg­i­men se­cures FDA ap­proval

In 2017, the WHO des­ig­nat­ed clar­ithromycin-re­sis­tant H. py­lori, a bac­te­r­i­al in­fec­tion that af­fects more than half of the glob­al pop­u­la­tion, a high pri­or­i­ty for an­tibi­ot­ic re­search and de­vel­op­ment. On Mon­day, Is­rael’s Red­Hill Bio­phar­ma se­cured FDA ap­proval for its ri­fabutin-based reg­i­men to ad­dress the alarm­ing rates of re­sis­tance to stan­dard-of-care ther­a­pies.

The new drug will be mar­ket­ed as Tal­i­cia, and the com­pa­ny says it plans a launch in the first quar­ter of 2020. The ther­a­py is an oral cap­sule com­pris­ing ri­fabutin, amox­i­cillin and a pro­ton pump in­hibitor, omepra­zole, and was test­ed in two late-stage tri­als, ERAD­I­CATE Hp and ERAD­I­CATE Hp2.

Shares of the drug­mak­er $RDHL jumped about 15.6% to $8 pre­mar­ket on Mon­day.

In the ERAD­I­CATE Hp study, Tal­i­cia, showed 89.4% ef­fi­ca­cy in erad­i­cat­ing H. py­lori in­fec­tion, sur­pass­ing the his­tor­i­cal stan­dard-of-care ef­fi­ca­cy lev­els of 70%.

In the con­fir­ma­to­ry ERAD­I­CATE Hp2 tri­al, Tal­i­cia was test­ed against an ac­tive com­para­tor ther­a­py — an amox­i­cillin and omepra­zole reg­i­men. Da­ta showed an 84% erad­i­ca­tion of H. py­lori in­fec­tion with Tal­i­cia ver­sus 58% in those who got the oth­er treat­ment. Tri­al da­ta al­so demon­strat­ed pa­tients ex­pe­ri­enced a high re­sis­tance to the stan­dard-of-care — con­sis­tent with their de­te­ri­o­rat­ing ef­fi­ca­cy — the com­pa­ny said when it pub­lished the re­sults last De­cem­ber.

“Stud­ies with Tal­i­cia found ze­ro re­sis­tance to ri­fabutin and showed 17% re­sis­tance to clar­ithromycin, a cur­rent stan­dard-of-care macrolide an­tibi­ot­ic, con­sis­tent with cur­rent da­ta show­ing that clar­ithromycin-con­tain­ing ther­a­pies fail in ap­prox­i­mate­ly 25-40% of cas­es,” said David Gra­ham, lead in­ves­ti­ga­tor of the Tal­i­cia phase III stud­ies, in a state­ment.

About two-thirds of the world’s pop­u­la­tion have H. py­lori in their bod­ies. But for most, it doesn’t cause ul­cers or any oth­er symp­toms. How­ev­er, it is a ma­jor cause of pep­tic ul­cer and gas­tri­tis and is con­sid­ered the strongest risk for gas­tric can­cer. About 35%, or over 100 mil­lion peo­ple, in the Unit­ed States are in­fect­ed, with an es­ti­mat­ed 2.5 mil­lion pa­tients treat­ed an­nu­al­ly in the re­gion.

The grow­ing scourge of an­tibi­ot­ic re­sis­tance is a glob­al is­sue that should ar­guably en­tice a swarm of R&D dol­lars, but these drugs com­mand rel­a­tive­ly cheap prices and do not of­fer a rich re­im­burse­ment, like can­cer drugs, which has in­cen­tivized most big phar­ma­ceu­ti­cal com­pa­nies 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 a six-month pri­or­i­ty re­view and eight years of US mar­ket ex­clu­siv­i­ty. The prod­uct is al­so pro­tect­ed un­til at least 2034, un­der var­i­ous US patents.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

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When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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