Takeda breaks off five-year pact with microbiome partner, handing back two preclinical drugs – Endpoints News

2022-08-27 01:34:38 By : Ms. Snow Gao

When Take­da first part­nered up with Finch Ther­a­peu­tics in 2017, the Japan­ese phar­ma put on the map what was still a very ear­ly-stage mi­cro­bio­me play­er aim­ing to cap­i­tal­ize on the idea that you could reap the ben­e­fits of fe­cal trans­plants with an oral pill — and its pre­clin­i­cal pro­gram for in­flam­ma­to­ry bow­el dis­ease.

Over the next few years, Take­da re­jigged the al­liance a few times, get­ting its hands on a sec­ond drug, tak­ing more re­spon­si­bil­i­ty for de­vel­op­ment and man­u­fac­tur­ing, and lat­er tap­ping Finch to con­duct more fea­si­bil­i­ty work.

But Take­da is now walk­ing away from it all.

Finch said its phar­ma part­ner has de­cid­ed to ter­mi­nate their col­lab­o­ra­tion, ef­fec­tive this No­vem­ber. As a re­sult, the biotech will re­gain glob­al rights to FIN-524 (pre­vi­ous­ly TAK-524, for ul­cer­a­tive col­i­tis) and FIN-525 (for Crohn’s dis­ease).

Both pro­grams, which con­tain spe­cif­ic bac­te­ria strains Finch deemed cru­cial in treat­ing dis­ease, re­main pre­clin­i­cal, al­though Finch had orig­i­nal­ly hoped that FIN-524 would reach the clin­ic with­in two and a half to three years.

“We are grate­ful for Take­da’s sub­stan­tial in­vest­ment in the FIN-524 and FIN-525 pro­grams and want to thank our ded­i­cat­ed col­leagues at Take­da who have worked along­side us to de­vel­op these in­no­v­a­tive prod­uct can­di­dates,” CEO Mark Smith said in a state­ment.

He added that Finch will ex­plore new col­lab­o­ra­tion op­por­tu­ni­ties for these as­sets.

In­ter­nal­ly, Finch has been fo­cus­ing its ef­forts on CP101, its “com­plete con­sor­tia” mi­cro­bio­me cap­sule for re­cur­rent C. dif­fi­cile in­fec­tions. De­spite a brief clin­i­cal hold due to man­u­fac­tur­ing con­cerns, the biotech is knee-deep in a crit­i­cal Phase III tri­al that may pave the way to­ward its first ap­proval.

Like many biotechs hun­ker­ing down for the biotech down­turn, Finch took to lay­offs ear­li­er this year to con­serve cash. Its stock is lan­guish­ing at $2.64, down about 75% from the be­gin­ning of the year.

On top of the $10 mil­lion cash Take­da hand­ed over in 2017, Finch has re­ceived $4 mil­lion in mile­stone pay­ments and more than $30 mil­lion in R&D re­im­burse­ment dur­ing the col­lab­o­ra­tion.

Now that the deal is wind­ing down, Take­da is al­so giv­ing Finch all the da­ta and in­tel­lec­tu­al prop­er­ty gen­er­at­ed, in­clud­ing “full rights to a large li­brary of char­ac­ter­ized bac­te­r­i­al iso­lates, da­ta from mul­ti­ple ex vi­vo and in vi­vo stud­ies, a suite of phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic as­says, and a sig­nif­i­cant body of chem­istry, man­u­fac­tur­ing, and con­trols (CMC) da­ta gen­er­at­ed dur­ing the in­ves­ti­ga­tion­al new drug (IND)-en­abling phase of de­vel­op­ment.”

“We are cur­rent­ly con­duct­ing a re­view of our port­fo­lio and as­sess­ing the fi­nan­cial and strate­gic im­pact of the dis­con­tin­u­a­tion of our col­lab­o­ra­tion with Take­da,” Smith said.

In 2021, 50 novel medications were approved by the Federal Drug Administration (FDA), the third-highest number of approvals on record and one of many indicators of the extraordinary advancements the medical field has seen in recent decades. But progress within the industry is not equally distributed. When acknowledging the contributions of more than 38,000 patients in its Drug Trials Snapshot of the same year, the FDA noted that “there were many programs where representation from certain racial and ethnic groups was low.” This carefully worded observation describes a long-standing limitation in the clinical trial sector.

Novartis CEO Vas Narasimhan has finally figured out how he can get Sandoz off his list of major headaches. He’s going to spin the generics giant out as a separate company.

The pharma giant says it will set up Sandoz as an independent company in H2 2023 after navigating the separation through regulators. The spinout will create a lumbering giant with a home on the SIX Swiss Exchange, an American Depositary Receipt program in the US, a pipeline of 15 biosimilars and a rep for mediocre performance.

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Following its announcement in March that it would begin enforcing its Covid-19 vaccine patents in wealthy countries, Moderna says it is suing Pfizer and BioNTech over their mRNA shot.

Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.

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Two Mondays have come and gone without Merck’s hotly-rumored takeover of Seagen, keeping observers waiting. And according to a new Bloomberg report, that’s because the two sides have yet to agree on a price.

Talks between Merck and Seagen have stalled over the acquisition price, the news wire reported, citing anonymous insiders. The discussion could still resume and lead to a deal, they added, although it clearly also may not. Seagen shares tumbled almost 7% to $153 in light of the report.

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A couple months after Bristol Myers Squibb brought its patent fight with Gilead’s Kite unit to the Supreme Court, Gilead is now making the argument that the petition should be denied because it challenges more than 50 years of precedent.

Juno – which was acquired by Celgene and then Bristol Myers Squibb — sued Gilead’s Kite unit back in 2017, alleging that the company’s CAR-T therapy Yescarta infringed on patents that were licensed to Juno by Memorial Sloan Kettering Cancer Center.

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The FDA’s postmarket regulations require that drug manufacturers notify the agency about any significant product quality defects in marketed products within three working days.

The reports, known as Field Alert Reports (FARs), are crucial for the agency to root out manufacturing issues that can cause recalls or lead to harm.

But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR  from 2018 to 2021, almost half (49%) of the sites did not submit a report.

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Two recent approvals for two expensive gene therapies for blood disorders — BioMarin’s $1.5 million Roctavian in the EU for hemophilia A and bluebird bio’s $2.8 million Zynteglo in the US for transfusion-dependent thalassemia — is shining a spotlight on outcomes-based pricing deals as both companies look to leverage the strong efficacy and durability of their therapies.

In the case of BioMarin’s Roctavian, execs said in an investor call this week that its outcomes-based agreements with EU member states will differ market by market but provide refunds when someone doesn’t respond to therapy. As only 6 of 134 patients resumed standard of care in the late-stage trial, Jeff Ajer, EVP and chief commercial officer of BioMarin said in an investor call that they’re “very enthusiastic” about such high responder rates.

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Novartis’ first-ever patient DTC ad for metastatic breast cancer drug Kisqali points up the broader and more recent proliferation of mBC treatment options in general.

The 15-second TV commercial features mBC patient and Kisqali user Lauren, who is a wife and mother of three girls, and talks about being the “first generation” of people who will change what it means to live with metastatic breast cancer.

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The Public Company Accounting Oversight Board (PCAOB) has struck an agreement with Chinese regulatory authorities that would allow the inspection of audit reports for US-listed Chinese companies. Now, according to SEC chair Gary Gensler, “The proof will be in the pudding.”

Roughly 200 Chinese companies — including biopharma companies BeiGene, Hutchmed, Zai Lab, I-Mab, Sinovac, Gracell Biotechnologies, Adagene and Burning Rock Biotech — have been singled out by the SEC for violating a new law governing US-listed companies. The law, called the Holding Foreign Companies Accountable Act, stipulates that any foreign companies audited by a firm that the nonprofit PCAOB is unable to review for three consecutive years should be delisted.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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