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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Am­gen ax­es 149 of its staff in Cam­bridge of­fice; Evotec, Mil­li­pore­Sig­ma en­ter re­search pact

→ Amgen has submitted a Worker Adjustment and Retraining Act (WARN) — a warning of impending mass layoffs 60 days in advance of the date — to the state of Massachusetts in the wake of the company’s exodus from the neurosciences R&D sector. David Reese, the company’s R&D chief, said at the time that the company is cutting ties in the field to focus on other undisclosed areas. In its WARN notice, the Cambridge-based company stated that 149 of its employees would be affected — among the total 180 being let go. The terminations will take effect on December 31, 2019.