Iron­wood, Al­ler­gan add a slate of PhI­I­Ib da­ta to its Linzess pitch for physi­cians, pa­tients

With the dust set­tled on an R&D spin­out, the ful­ly com­mer­cial op­er­a­tions at Iron­wood have come up with some late-stage da­ta to up its Linzess mar­ket­ing game.

Mark Mal­lon As­traZeneca

Iron­wood, along with part­ner Al­ler­gan, set out to col­lect ev­i­dence that their drug can im­prove the over­all ab­dom­i­nal symp­toms of ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C), not just con­sti­pa­tion. And the com­pa­nies say that’s what they found in the Phase II­Ib: Pa­tients tak­ing Linzess for 12 weeks saw a 29.7% mean de­crease from base­line in a week­ly score that mea­sured bloat­ing, pain and dis­com­fort, com­pared to 18.3% for place­bo (p<0.0001).

The tri­al al­so hit its sec­ondary end­points, in­clud­ing 40.5% of the drug arm meet­ing the cri­te­ria of a re­spon­der ver­sus 23.4% in the place­bo co­hort (p<0.0001).

The new da­ta are meant to bol­ster Iron­wood sales reps as they com­mu­ni­cate with doc­tors and pa­tients, ide­al­ly grow­ing a 7-year-old drug that brought in $785 mil­lion in 2018.

Boris Peak­er Cowen

Cowen an­a­lyst Boris Peak­er ex­plained it this way:

Linzess’ cur­rent la­bel notes re­duc­tions in “ab­dom­i­nal pain,” but not “bloat­ing” or “dis­com­fort,”, which man­age­ment stat­ed are the terms most fre­quent­ly used by pa­tients to de­scribe their symp­toms. The goal of the pro­gram was to en­able the com­pa­ny to align its mar­ket­ing with the lan­guage that physi­cians and pa­tients use day-to-day in the clin­ic

Iron­wood CMO Mike Shet­z­line added that the ab­dom­i­nal symp­toms are typ­i­cal­ly iden­ti­fied by pa­tients as the “most both­er­some.”

While the da­ta are “in­cre­men­tal­ly pos­i­tive for Linzess,” though, Peak­er sees no im­pact on his sales pro­jec­tions.

Pe­ter Hecht Cy­cle­ri­on

Linzess is one of two ap­proved prod­ucts Pe­ter Hecht kept for Iron­wood while spin­ning out the rest of the R&D work to a new com­pa­ny called Cy­cle­ri­on — un­der in­vestor pres­sure. The co-founder and long­time CEO then de­camped for the new out­fit and passed the reins to Mark Mal­lon, an As­traZeneca vet with sig­nif­i­cant in­ter­na­tion­al ex­po­sure.

Aside from a much less suc­cess­ful Tru­lance, Linzess al­so faces some de­gree of com­pe­ti­tion from Motegri­ty, a con­sti­pa­tion drug Take­da now owns cour­tesy of its Shire buy­out.

Gener­ics for the drug could be­gin to emerge in 2030, Peak­er added, at which point Iron­wood’s cur­rent­ly ex­per­i­men­tal ther­a­pies — MD-7246 for IBS with di­ar­rhea and IW-3718 for gas­troe­sophageal re­flux dis­ease — are ex­pect­ed to fill the gap.

So­cial im­age: Richard Drew, Ap Im­ages

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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