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ALETH / LIFESCI-BRIEF / 2025-10-03 / GENMAB TO BUY DUTCH BIOTECH MERUS FOR $8BN

Aleth LifeSci Brief: 29 Sep-3 Oct 2025

Genmab to buy Dutch biotech Merus for $8bn

In this edition

Monday 29 September

GSK named Luke Miels its next chief executive, with Emma Walmsley stepping down at the end of the year after about eight years.

Miels, the group’s chief commercial officer since he joined from AstraZeneca in 2017, becomes chief executive and joins the board on 1 January 2026. Walmsley leaves the board on 31 December and stays employed until the end of September 2026 to hand over. GSK pitched the change around a run of 15 planned launches between 2025 and 2031. The move keeps one of Britain’s two largest drugmakers under an internal appointment rather than an outside hire.

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AstraZeneca will add a direct New York listing while keeping London as its primary home.

The board recommended a “harmonised” structure listing its ordinary shares on the New York Stock Exchange, Nasdaq Stockholm and the London Stock Exchange under the single ticker AZN, replacing the American Depositary Receipts it currently trades on Nasdaq.

The company said it stays UK-listed, UK-headquartered and UK tax-resident, and remains in the FTSE 100. Chair Michel Demaré framed the change as a way to reach a broader mix of global investors rather than a step away from Britain. Trading under the new structure was set to begin in early February 2026, subject to a shareholder vote.

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Genmab agreed to buy the Dutch cancer biotech Merus for about $8bn.

The Danish company is paying $97.00 a share in cash, a premium of roughly 41%, funded from cash and about $5.5bn of debt. The deal brings in Merus’s bispecific antibody pipeline, led by petosemtamab, a head and neck cancer candidate carrying two FDA breakthrough designations. Genmab cast the purchase as a move toward a wholly-owned commercial model, with completion expected early in the first quarter of 2026.

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The US will hold European and Japanese drug imports to a 15% tariff, sparing them the 100% levy Trump had threatened.

The ceiling comes from the framework the US and EU set out in a joint statement on 21 August, which caps the combined tariff on EU pharmaceuticals, semiconductors and lumber at 15%, with a parallel arrangement covering Japan. It sits far below the 100% tariff on branded and patented drugs that Trump announced the week before for manufacturers not building US plants. For companies shipping into the US from Europe and Ireland, the cap limits the exposure the 100% threat had opened.

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The FDA approved Eli Lilly’s Inluriyo, an oral drug for advanced breast cancer driven by an ESR1 mutation.

Inluriyo (imlunestrant) is a selective estrogen receptor degrader for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after endocrine therapy.

Approval rested on the Phase 3 EMBER-3 trial, where it cut the risk of progression or death by 38% against standard endocrine therapy in patients carrying the mutation. The ESR1 mutation is a common route to endocrine resistance, and Guardant Health’s blood test was cleared alongside the drug to identify eligible patients.

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Tuesday 30 September

Drugmakers rushed out direct-to-patient discounts as the White House’s pricing deadline arrived.

The 29 September deadline traced back to letters Trump sent 17 manufacturers on 31 July, demanding “most favored nation” prices for Medicaid and direct-to-consumer sales at the lowest price paid by other wealthy countries. Novartis said it would sell its immunology drug Cosentyx to cash-paying US patients at 55% off list from 1 November.

Boehringer Ingelheim launched a platform, Boehringer Ingelheim Access, offering its inhaler Spiriva Respimat at $35 a month, with more of its respiratory and diabetes range to follow. Neither release named the administration, though both landed on the deadline.

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AstraZeneca and Daiichi Sankyo said Enhertu worked in earlier-stage breast cancer, moving the drug toward curative-intent use.

In the Phase 3 DESTINY-Breast05 trial, Enhertu (trastuzumab deruxtecan) beat T-DM1 on invasive disease-free survival at a planned interim analysis, a result the companies called highly statistically significant.

The trial enrolled 1,635 patients with high-risk HER2-positive early breast cancer who still had invasive disease after pre-surgery treatment. The topline gave no numbers; the companies held the detail for the ESMO congress on 18 October. Enhertu is one of AstraZeneca’s largest cancer franchises, until now established in metastatic disease.

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Wednesday 1 October

Pfizer became the first big drugmaker to strike a US pricing deal with President Trump, in exchange for three years free of pharma tariffs.

Pfizer agreed to sell some medicines direct to patients through a government site, TrumpRx.gov, at discounts averaging about 50% and reaching 85%, and to give state Medicaid programmes “most favored nation” prices and launch new drugs in the US at parity with other developed markets.

In return, its products under the Section 232 investigation escape pharmaceutical tariffs for three years, tied to continued US investment; the company also pledged $70bn in US research and capital spending. The White House called the agreement a template it expected other manufacturers to match.

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The UK Health Secretary told the Labour conference that weight-loss jabs should reach millions more people.

Wes Streeting said the drugs “could help us finally defeat obesity” and warned that leaving them to those who can pay would mark “a return to the days when health was determined by wealth.” He argued the treatments should be available on the NHS to all rather than some, but stopped short of committing to widen access. Mounjaro reached NHS primary care from June on a rationed basis, and pricing talks with manufacturers were still under way.

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The US government shutdown began, set to furlough more than 32,000 Health and Human Services staff.

The department’s contingency plan put 32,460 employees on furlough from the second day of the lapse, about 41% of its workforce, while keeping roughly 47,000. The FDA’s drug and device reviews continue, funded by user fees rather than annual appropriations. The plan warns that CDC public communication would be hampered, that CMS oversight of major contractors would stop, and that the NIH would admit new patients to its research hospital only where medically necessary.

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Thursday 2 October

Takeda pulled out of cell therapy and put its platform up for a partner, the latest big drugmaker to leave the field.

The company said it would discontinue its cell therapy research in a portfolio reprioritisation and look for an external partner to carry on its gamma delta T-cell platform, which has no active trials. It flagged an impairment of about 58bn yen and said it would steer near-term spending to small molecules, biologics and antibody-drug conjugates.

The same day, Galapagos said it had received non-binding offers for its own cell therapy business, mostly from consortia of financial investors, with a decision due by 5 November. Novo Nordisk had already stepped back from the modality.

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The US confirmed that Japanese drug imports face a 15% tariff, not the 100% threatened rate.

The 15% ceiling comes from Executive Order 14345, signed on 4 September to implement the US-Japan trade deal, which caps most Japanese imports at that level and backdates it to 7 August. Generic medicines and their ingredients can be cut to zero, while branded and patented Japanese drugs sit at 15%, far below the 100% Trump threatened on the Section 232 track. Trade press reported that confusion remained over how the tariff would apply in practice.

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Friday 3 October

The Treasury privately reckons AstraZeneca’s New York listing could cost it as much as £200m a year in stamp duty.

The Financial Times reported the internal estimate, which turns on the 0.5% stamp duty reserve tax charged on London share purchases but not on US-traded stock. AstraZeneca, the largest company on the London market, disclosed the direct New York listing on 29 September while keeping its FTSE 100 place. The figure lands as the government looks for revenue before the November Budget and tries to revive London’s capital markets.

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Alphabet has spent two years separating its health unit Verily to ready it for a sale or spinoff.

The disclosure came from a Google security executive giving evidence in the US antitrust case over its ad-tech business, and was the first public confirmation that Alphabet wants Verily to stand alone. Bloomberg reported that Alphabet plans to keep a large stake while the separation makes room for outside investors. Verily, Alphabet’s life-sciences and health-data arm, had cut staff and narrowed to AI and data earlier in the year.

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Amgen said its cholesterol jab Repatha cut cardiovascular events in patients who had never had a heart attack or stroke.

The Phase 3 VESALIUS-CV trial met both primary endpoints in more than 12,000 high-risk patients, extending the PCSK9 inhibitor’s evidence from established heart disease into primary prevention, a much larger group. Amgen called the results statistically and clinically significant, with no new safety signals, over a median 4.5 years. It withheld the size of the benefit until the American Heart Association meeting on 8 November.

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