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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