Am­neal touts re­sults from Phase III tri­al in Parkin­son's; No­vaRock part­ners on can­cer drug

Am­neal Phar­ma­ceu­ti­cals an­nounced pos­i­tive re­sults yes­ter­day from a piv­otal Phase III clin­i­cal tri­al that eval­u­at­ed IPX-203 in pa­tients with Parkin­son’s dis­ease who have mo­tor fluc­tu­a­tions.

The tri­al met its pri­ma­ry end­point, demon­strat­ing su­pe­ri­or “Good On” time — time with­out dysk­i­ne­sia — from base­line in hours per day at the end of the 13-week dou­ble-blind­ed treat­ment pe­ri­od with IPX-203, an ex­tend­ed-re­lease for­mu­la­tion of car­bidopa/lev­odopa. The drug da­ta was com­pared with im­me­di­ate-re­lease car­bidopa/lev­odopa.

Based on these re­sults, Am­neal plans to sub­mit an NDA for IPX-203 with the FDA in mid-2022.

“These pos­i­tive da­ta from the Phase 3 tri­al of IPX-203 rep­re­sent a sub­stan­tial step for­ward in strength­en­ing Am­neal’s Spe­cial­ty Phar­ma port­fo­lio, which is heav­i­ly fo­cused on med­i­cines for cen­tral ner­vous sys­tem dis­or­ders. We look for­ward to sub­mit­ting an NDA with the FDA and po­ten­tial­ly mak­ing this treat­ment avail­able to the PD com­mu­ni­ty,” co-CEOs Chi­rag and Chin­tu Pa­tel said in a state­ment. — Paul Schloess­er

No­vaRock bags $7.5M in cash for can­cer drug pact

No­vaRock Bio­ther­a­peu­tics to­day an­nounced that they have en­tered in­to an ex­clu­sive li­cense agree­ment and strate­gic part­ner­ship with Flame Bio­sciences.

“We are very pleased to be part­ner­ing with Flame and their world-class clin­i­cal team. The col­lab­o­ra­tion with Flame marks a sol­id step to­wards get­ting No­vaRock’s in­no­v­a­tive port­fo­lio in­to the glob­al mar­ket,” said Han Li, CEO of No­vaRock.

Un­der their agree­ment, No­vaRock has grant­ed Flame the ex­clu­sive rights to NBL-015, No­vaRock’s clin­i­cal stage pro­gram for pan­cre­at­ic and gas­tric can­cer. While those ex­clu­sive rights are lim­it­ed to every­where out­side of Chi­na, Hong Kong, Macau, and Tai­wan, Flame is re­spon­si­ble for the de­vel­op­ment, reg­u­la­to­ry ap­proval, and com­mer­cial­iza­tion of NBL-015.

NBL-015’s IND was cleared by the FDA in May.

Flame will al­so col­lab­o­rate with No­vaRock on dis­cov­er­ing and de­vel­op­ing two new bis­pe­cif­ic an­ti­bod­ies, for which Flame will re­tain ex­clu­sive rights. Those an­ti­bod­ies are ex­pect­ed to hit clin­i­cal de­vel­op­ment in ap­prox­i­mate­ly two years.

No­vaRock will re­ceive an up­front pay­ment of $7.5 mil­lion with the po­ten­tial to re­ceive de­vel­op­ment mile­stone pay­ments of up to $172.5 mil­lion. No­vaRock is al­so el­i­gi­ble to re­ceive sales mile­stone pay­ments of up to $460 mil­lion and roy­al­ties based on a cer­tain per­cent­age of the net sales of those new an­ti­bod­ies. — Paul Schloess­er

MS ex­pert at Johns Hop­kins to col­lab­o­rate on NL­RX1 re­search

Pe­ter Cal­abre­si

Mul­ti­ple scle­ro­sis ex­pert Pe­ter Cal­abre­si, a pro­fes­sor of neu­rol­o­gy at Johns Hop­kins, has signed on to col­lab­o­rate with Lan­dos Bio­phar­ma to val­i­date the NL­RX1 im­munometa­bol­ic path­way in MS.

Their lead drug, NX-13, is an NL­RX1 ag­o­nist in de­vel­op­ment for ul­cer­a­tive col­i­tis and Crohn’s dis­ease. And now the biotech plans to use NIH funds to ex­plore how it may work in CNS, with both MS and Alzheimer’s on the radar.

The com­pa­ny was found­ed by Vir­ginia Tech pro­fes­sor Josep Bas­saganya-Ri­era and won ear­ly back­ing from Chris Garabe­di­an at Xon­toge­ny. — John Car­roll

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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