FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Fed­er­al Trade Com­mis­sion on Fri­day with­drew its re­main­ing case against Ab­b­Vie af­ter the Supreme Court de­clined to re­view a low­er court’s rul­ing.

The punt by SCO­TUS means that while the Illi­nois phar­ma com­pa­ny il­le­gal­ly blocked pa­tients’ ac­cess to low­er-cost al­ter­na­tives to its testos­terone drug An­dro­Gel, the FTC will no longer be able to re­turn about $500 mil­lion di­rect­ly to An­dro­Gel con­sumers.

“This case high­lights the press­ing need for leg­is­la­tion re­in­stat­ing the FTC’s au­thor­i­ty to seek eq­ui­table mon­e­tary re­lief for con­sumers in com­pe­ti­tion cas­es,” Hol­ly Ve­do­va, FTC’s act­ing di­rec­tor of the Bu­reau of Com­pe­ti­tion, said in a state­ment. “Con­gress should act quick­ly to re­store Sec­tion 13(b) of the FTC act and the Com­mis­sion’s abil­i­ty to re­turn to con­sumers mon­ey lost due to il­le­gal an­ti­com­pet­i­tive be­hav­ior by phar­ma­ceu­ti­cal com­pa­nies.” — Zachary Bren­nan

Eu­rope’s new clin­i­cal tri­al sys­tem com­ing in 2022

The long-await­ed Eu­ro­pean Clin­i­cal Tri­als In­for­ma­tion Sys­tem is set to go live on Jan. 31, 2022, the Eu­ro­pean Med­i­cines Agency an­nounced Mon­day.

The launch of the CTIS will mean spon­sors no longer have to sub­mit tri­al ap­pli­ca­tions to sep­a­rate na­tion­al au­thor­i­ties and can in­stead send them to a sin­gle en­try point for sub­mis­sion, au­tho­riza­tion and safe­ty re­port­ing in the EU, Ice­land, Liecht­en­stein and Nor­way.

“With CTIS, spon­sors can ap­ply for clin­i­cal tri­al au­tho­ri­sa­tion in up to 30 EEA coun­tries with a sin­gle ap­pli­ca­tion,” the EMA said, not­ing the up­com­ing tran­si­tion pe­ri­od.

EU mem­ber states will work in CTIS af­ter it goes live, but for one year, un­til Jan. 31, 2023, ap­pli­cants can still choose whether to sub­mit their ap­pli­ca­tion to start a clin­i­cal tri­al ac­cord­ing to the cur­rent sys­tem, Ethe MA says. Af­ter that date, sub­mis­sion to the new sys­tem is manda­to­ry, and by Jan. 31, 2025, all on­go­ing tri­als ap­proved un­der the old sys­tem will need to mi­grate to the new one. — Zachary Bren­nan

Abing­worth bets $100M on CymaBay’s up­com­ing Phase III

A year af­ter the FDA lift­ed a clin­i­cal hold on CymaBay’s se­ladel­par and gave it a green light fol­low­ing safe­ty fears, Abing­worth is step­ping up with a $100 mil­lion bet on a Phase III gam­ble.

Abing­worth will hand over $75 mil­lion of that over the next six months to fund their late-stage ef­fort on pri­ma­ry bil­iary cholan­gi­tis (PBC). And CymaBay will have an op­tion on the fourth tranche.

In re­turn, the biotech agreed to a six-year re­pay­ment plan, de­pend­ing on po­ten­tial ap­provals in the US and EU. And it will al­so pay out sales mile­stones.

Abing­worth has a not­ed in­ter­est in risk-shar­ing deals, par­tic­u­lar­ly on late-stage piv­otal ef­forts.

“By thought­ful­ly risk-shar­ing de­vel­op­ment costs with Abing­worth, who shares our be­lief in the po­ten­tial of se­ladel­par to serve as an im­proved sec­ond-line treat­ment for pa­tients with PBC, we have se­cured the ad­di­tion­al fund­ing need­ed for the Phase 3 pro­gram,” says CymaBay CEO Su­jal Shah. — John Car­roll

Irish Tax Ap­peals Com­mis­sion up­holds as­sess­ment of Shire’s break fee

Take­da’s at­tempts to ap­peal a tax as­sess­ment from a break fee Shire re­ceived from Ab­b­Vie back in 2014 have failed. But the com­pa­ny’s not giv­ing up just yet.

Ab­b­Vie backed out of a pro­posed $55 bil­lion pur­chase of Shire near­ly sev­en years ago, cit­ing rule changes by the US Trea­sury De­part­ment in­tend­ed to cur­tail deals in which US com­pa­nies would re­domi­cile over­seas to take ad­van­tage of low­er cor­po­rate tax rates, ac­cord­ing to a Reuters re­port. When it walked away, Ab­b­Vie paid the Irish com­pa­ny $1.64 bil­lion. And in 2018, Shire re­ceived a tax as­sess­ment from the Irish Rev­enue Com­mis­sion­ers for €398 mil­lion ($472.7 mil­lion).

Take­da ac­quired Shire in 2019, and ap­pealed the tax as­sess­ment in a hear­ing late last year. On Fri­day, the Irish Tax Ap­peals Com­mis­sion de­cid­ed to up­hold the as­sess­ment.

“Take­da in­tends to chal­lenge this out­come through all avail­able le­gal means in­clud­ing ap­peal­ing the de­ci­sion to the Irish courts,” the com­pa­ny said in a state­ment. — Nicole De­Feud­is 

New da­ta show promise for a six-week reg­i­men of Bio­gen’s Tysabri

While Bio­gen’s mul­ti­ple scle­ro­sis drug Tysabri is cur­rent­ly ap­proved to be ad­min­is­tered every four weeks, one analy­sis showed that giv­ing every six weeks could low­er pa­tients’ risk of de­vel­op­ing pro­gres­sive mul­ti­fo­cal leukoen­cephalopa­thy (PML), a rare but se­ri­ous brain in­fec­tion.

On Mon­day, the com­pa­ny un­veiled new da­ta show­ing that the six-week reg­i­men is no less ef­fec­tive than the four-week one.

Ac­cord­ing to Bio­gen, pa­tients who re­ceived Tysabri every four weeks saw a mean num­ber of new or new­ly en­larg­ing T2 hy­per­in­tense le­sions at week 72 of 0.05, com­pared to 0.02 for the pa­tients re­ceiv­ing the drug every six weeks. That fig­ure isn’t clin­i­cal­ly mean­ing­ful, the com­pa­ny said, adding that the p-val­ue was 0.0755.

Ac­cord­ing to new da­ta from a two-year study, Bio­gen’s mul­ti­ple scle­ro­sis drug Tysabri shows no mean­ing­ful dif­fer­ence in ef­fi­ca­cy when giv­en every six weeks as op­posed to the cur­rent­ly every four.

“The nu­mer­i­cal dif­fer­ence was dri­ven by a high num­ber of le­sions oc­cur­ring in two par­tic­i­pants in the Q6W arm – one pa­tient who de­vel­oped le­sions three months af­ter treat­ment dis­con­tin­u­a­tion and a sec­ond pa­tient who de­vel­oped asymp­to­matic pro­gres­sive mul­ti­fo­cal leukoen­cephalopa­thy (PML)…” Bio­gen said in a state­ment.

The pro­por­tion of pa­tients who de­vel­oped new or new­ly en­larg­ing T2 le­sions was 4.1% in the four-week arm, and 4.3% in the six-week arm.

A com­plete analy­sis of the da­ta is on­go­ing and more de­tailed re­sults will be shared in a fu­ture sci­en­tif­ic fo­rum, Bio­gen said. — Nicole De­Feud­is 

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

FDA ac­cepts In­tel­li­a's IND for CRISPR and TCR-T cell ther­a­py; San­té clos­es Fund IV at $260M

Riding the coattails of a massive $600 million cash raise in June, Intellia announced that the FDA accepted their IND application for their gene editing treatment NTLA-5001, built as a treatment for acute myeloid leukemia.

The Cambridge, MA biotech said that they have plans to start patient screening in a Phase I/IIa study by the end of 2021. The study will evaluate the effects of a single dose of the treatment in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants.

Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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