A month af­ter GSK's win in Zan­tac can­cer case, plain­tiffs file dozens more suits

GSK now has dozens more Zan­tac law­suits to con­tend with.

Plain­tiffs on Wednes­day filed 88 suits against GSK in Delaware court on be­half of more than 7,000 claimants who al­lege the pop­u­lar ran­i­ti­dine heart­burn prod­ucts caused a range of can­cers. Pfiz­er, Boehringer In­gel­heim and Sanofi, which owned Zan­tac rights at var­i­ous points in time, were al­so named in the suit, in ad­di­tion to Ther­mo Fish­er’s Patheon Man­u­fac­tur­ing Ser­vices.

GSK has been named in about 3,000 per­son­al in­jury cas­es as well as class ac­tion suits. Plain­tiffs in mul­ti­dis­trict lit­i­ga­tion in Flori­da ini­tial­ly named 10 types of can­cer in the suit, but lat­er with­drew breast, kid­ney, col­orec­tal, prostate and lung. Those can­cers are still be­ing pur­sued in state courts, GSK said last month. And on Fri­day, a Sanofi spokesper­son at­trib­uted the re­cent surge in state court fil­ings to plain­tiffs who ex­it­ed fed­er­al MDL, or whose al­leged in­juries have been dropped.

“The re­cent in­crease in state court fil­ings pre­dom­i­nant­ly in­volve plain­tiffs who have opt­ed to ex­it the fed­er­al mul­ti-dis­trict lit­i­ga­tion and whose al­leged in­juries lead plain­tiffs’ lawyers in the MDL have aban­doned,” the spokesper­son said. “As plain­tiffs search for new venues, Sanofi will con­tin­ue to vig­or­ous­ly de­fend it­self against these claims, which the med­ical, sci­en­tif­ic, and reg­u­la­to­ry com­mu­ni­ties have ex­ten­sive­ly eval­u­at­ed and have found to be with­out mer­it.”

The new cas­es al­lege nine types of can­cer, in­clud­ing blad­der, breast, col­orec­tal and in­testi­nal, esophageal, gas­tric, liv­er, lung, pan­cre­at­ic and prostate.

Zan­tac was first ap­proved as a pre­scrip­tion med­i­cine for heart­burn in 1983, and af­ter a decade of record sales, GSK be­gan work­ing on an over-the-counter for­mu­la­tion. Sev­er­al OTC forms were OK’d in 1995, and those sales rights lat­er passed through the hands of Pfiz­er, Boehringer In­gel­heim and Sanofi.

How­ev­er, the block­buster drug was re­called in 2019 over un­ac­cept­ably high lev­els of a po­ten­tial car­cino­gen known as ND­MA. Plain­tiffs say stud­ies have shown that ran­i­ti­dine can trans­form in­to ND­MA in the body or on the shelf in high tem­per­a­tures. Pre­vi­ous law­suits have claimed that a sin­gle ran­i­ti­dine pill can con­tain ND­MA lev­els that are “hun­dreds of times high­er” than the FDA’s ac­cept­able lim­it. In 2020, the FDA re­quest­ed the re­call of all ran­i­ti­dine prod­ucts.

“We didn’t ob­serve un­ac­cept­able lev­els of ND­MA in many of the sam­ples that we test­ed,” for­mer act­ing com­mis­sion­er Janet Wood­cock said around the time of the re­call. “How­ev­er, since we don’t know how or for how long the prod­uct might have been stored, we de­cid­ed that it should not be avail­able to con­sumers and pa­tients un­less its qual­i­ty can be as­sured.”

GSK said in a state­ment last month that reg­u­la­to­ry agen­cies, in­clud­ing the FDA, have since con­clud­ed there is no ev­i­dence of a link be­tween ran­i­ti­dine and can­cer. In No­vem­ber 2019, the FDA de­ter­mined that ND­MA lev­els in ran­i­ti­dine are sim­i­lar to lev­els in some foods such as grilled and smoked meats.

“There have been no ma­te­r­i­al de­vel­op­ments to what has been pre­vi­ous­ly dis­closed,” the GSK state­ment read.

“The over­whelm­ing weight of the sci­en­tif­ic ev­i­dence sup­ports the con­clu­sion that there is no in­creased can­cer risk as­so­ci­at­ed with the use of ran­i­ti­dine. GSK will con­tin­ue to vig­or­ous­ly de­fend it­self against all claims al­leg­ing oth­er­wise,” the com­pa­ny not­ed on Fri­day.

“The over­whelm­ing sci­en­tif­ic ev­i­dence es­tab­lish­es that the use of Zan­tac is not as­so­ci­at­ed with an in­creased risk of can­cer,” a Boehringer In­gel­heim spokesper­son said on Fri­day. “We will de­fend any al­le­ga­tions oth­er­wise and do not com­ment on specifics of pend­ing lit­i­ga­tion.”

Pfiz­er and Patheon did not re­spond to re­quests for com­ment as of press time.

Last month, GSK’s first sched­uled Zan­tac can­cer tri­al was vol­un­tar­i­ly dis­missed by the plain­tiff. The com­pa­ny said it didn’t set­tle the claim or pay any­thing in ex­change for drop­ping the case.

“The over­whelm­ing weight of the sci­en­tif­ic ev­i­dence sup­ports the con­clu­sion that there is no in­creased can­cer risk as­so­ci­at­ed with the use of ran­i­ti­dine,” GSK said at the time.

This sto­ry has been up­dat­ed to in­clude com­ment from GSK.

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The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

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Dave Marek, Myovant CEO

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Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

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German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.