In March, Zealand Pharma gutted its US workforce and said it was looking for strategic partnerships for its diabetes products following a disappointing first year on the market for its diabetes treatment Zegalogue.
On Wednesday morning, the Danish biotech followed up with its plans, announcing it is licensing Zegalogue out to Novo Nordisk in exchange for DKK 25 million upfront (approximately $3.3 million USD). In addition, Zealand can get DKK 45 million in near-term milestones and DKK 220 million in sales.
Novo Nordisk will now take on the marketing of Zegalogue worldwide, adding another drug to its wide diabetes portfolio. But Zealand will still be in charge of certain regulatory and development work to get Zegalogue approved outside the US.
In March of last year, Zealand won its first approval for Zegalogue, a glucagon analogue, to treat severe low blood sugar in diabetes patients older than 6 years of age. However, Zegalogue fell flat in the market — and the biotech slashed sales projections for 2022 by more than half as a result.
In addition to hollowing out its workforce, Zealand revamped its leadership, replacing CEO Emmanuel Dulac with R&D head Adam Steensberg. It also hired David Kendall as CMO, and in November, the biotech will be getting a new CFO in Henriette Wennicke, who actually began her career at Novo Nordisk.
In a statement this morning, Steensberg said, “This agreement is another important step in our strategy to establish commercial partnerships as we create and develop innovative next generation peptide therapeutics.”
Zealand is also working on adding to Zegalogue’s indications — the biotech said it’s planning to submit an NDA early next year on the back of a Phase III readout of the glucagon analogue for congenital hyperinsulinism in infants and young children.
Illumina on Tuesday laid out two scenarios for its $8 billion Grail acquisition, both of which put itself in a tough spot.
The San Diego-based company plans to appeal a European Commission decision to block the merger, with the bloc reasoning Illumina could use its DNA sequencing dominance to throttle Grail competitors’ access to the technology. But if the lengthy appeal fails, Illumina is preparing for another option: divesting Grail.
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Second time’s the charm for Amylyx and its experimental ALS drug. In an unusual twist, outside experts on an FDA advisory committee voted 7-2 in favor of approving AMX0035, just months after voting against the drug in a first adcomm.
Even more unusual was a promise from both CDER’s neuroscience director Billy Dunn and Amylyx’s co-CEOs that AMX0035 would be pulled from the market if the drug fails its ongoing Phase III Phoenix trial.
European regulators blocked Illumina’s $8 billion acquisition of Grail on Tuesday, dealing a whiplash blow to the biotech just days after it prevailed over an FTC challenge.
The EC put out a statement on the move, saying the deal would have “stifled innovation, and reduced choice” in the growing blood-based cancer screening test market. Specifically, the bloc noted that because other companies rely on Illumina’s NGS systems technology for their own products, a merger would have granted Illumina an unfair advantage over its rivals.
Giuseppe Ciaramella joined Moderna in 2014, back when the mRNA specialist only employed about 70 people. There, as CSO of the infectious disease division, he helped build the initial mRNA vaccine pipeline and steered Moderna’s first vaccine program toward an IND.
He left for Beam Therapeutics four years later, before a wildly successful Covid-19 vaccine propelled Moderna to the biotech hall of fame.
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On the cusp of asking the FDA to approve its cancer drug for progressing desmoid tumors, SpringWorks is out with a fuller picture of the therapy’s performance in a Phase III trial four months after declaring a topline win.
But before the biotech could disclose those results in a late-breaking oral presentation at ESMO, SpringWorks teed up investor interest with a $225 million private placement and an expanded collaboration with GSK on a Blenrep combination, which includes $75 million in equity and $550 million on the line. Those two deals, padding SpringWorks’ cash reserves until 2026, led to a nearly 6% uptick in the company’s shares {SWTX} Wednesday afternoon.
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PARIS — In 2020, Roche’s Tecentriq, a PD-L1 inhibitor, got an FDA nod in combination with Avastin for untreated advanced liver cancer, becoming the first immune checkpoint therapy to make it to the first line for these tumors. That approval, deemed a “landmark,” came on the back of a Phase III trial that showed the Tecentriq combo prolonged survival longer than Nexavar — the Bayer drug that had stood unbeaten as the standard of care in first line liver cancer since 2007.
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PARIS — This weekend at ESMO, the KRAS battle between Amgen and its pesky biotech rivals at Mirati will continue with new slices of combo data for advanced cases of colorectal cancer. And once again, Mirati will get in with a solid punch.
Amgen has some combination data on its approved pioneer Lumakras and its EGFR inhibitor Vectibix with a 30% overall response rate — way better than the meager 9.3% it posted earlier for the monotherapy.
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When Bruno Abner and his creative team started working up campaign ideas for a new hormone-free contraceptive for women called Phexxi, they knew they wanted the message to be bold and unapologetic.
Then along came actress Annie Murphy. Best known for her comedic turn as Alexis Rose on the hit show “Schitt’s Creek,” Murphy opened the door to humor when McCann Health’s client Evofem Biosciences suggested her as a spokesperson.
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There’s Just, and there’s Good.
The first was sold in summer 2019. And the PD-1 IL-2 portion of the latter is now entering the fold of Roche.
The two biotechs aren’t related, but Good Therapeutics founder and CEO John Mulligan “liked the idea of having Good and Just in Seattle,” calling his startup’s moniker a “riff” on the Evotec-acquired Just Biotherapeutics.
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