Pharmaceutical Market Europe • February 2025 • 6-7

NEWS

Johnson & Johnson to acquire Intra-Cellular for $14.6bn

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Johnson & Johnson (J&J) has announced that it will be expanding its neuroscience capabilities by acquiring Intra-Cellular Therapies for approximately $14.6bn.

The deal gives J&J access to Intra-Cellular’s central nervous system disorder drugs, including antipsychotic medication Caplyta (lumateperone).

The once-daily oral therapy is already approved in the US to treat adults with schizophrenia, and depressive episodes associated with bipolar I or II disorder as a monotherapy and adjunctive therapy with lithium or valproate.

A supplemental new drug application has also been submitted to the US regulator for the use of Caplyta as an adjunctive treatment for major depressive disorder, while additional late-stage trials of the drug in other mental health disorders are underway.

Beyond Caplyta, the acquisition includes a phase 2 candidate being evaluated in generalised anxiety disorder and Alzheimer’s disease-related psychosis and agitation, as well as a clinical-stage pipeline that “further complements and strengthens” J&J’s current areas of focus.

Under the terms of the agreement, which is expected to close later this year subject to applicable regulatory approvals, J&J will acquire all outstanding shares of Intra-Cellular Therapies for $132 per share in cash.


AbbVie and Neomorph partner
in deal worth $1.64bn

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AbbVie has partnered with Neomorph to develop new molecular glue degraders (MGDs) for multiple targets across oncology and immunology, with the deal worth $1.64bn.

The collaboration and option-to-licence agreement combines AbbVie’s capabilities in oncology and immunology drug development with Neomorph’s molecular glue discovery platform.

MGDs are a relatively new class of drugs designed to selectively target and trigger degradation of proteins that drive immune system dysregulation cancer growth.

The approach is believed to open up opportunities to target proteins that are considered ‘undruggable’ by conventional therapeutics.

Neomorph will receive an undisclosed upfront payment under the deal and will be eligible for up to $1.64bn in option fees and milestones, as well as tiered royalties on net sales.

Steven Elmore, vice president, small molecule therapeutics and platform technologies at AbbVie, said protein degraders “represent a groundbreaking advancement in the field of drug discovery”.

The deal is not AbbVie’s first of the year after it partnered with Simcere Zaiming earlier in January to develop an investigational drug candidate in phase 1 clinical development for patients with relapsed or refractory multiple myeloma.


Eli Lilly and Scorpion agree on $2.5bn oncology deal

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Eli Lilly has said it will be expanding its oncology pipeline by acquiring Scorpion Therapeutics’ PI3Kα inhibitor programme in a deal worth up to $2.5bn.

STX-478 is currently being evaluated in a phase 1/2 trial as a monotherapy and as part of a combination treatment for breast cancer and other advanced solid tumours.

PI3Kα mutations occur in more than 166,000 patients with breast, gynaecological and other solid tumours in the US every year.

STX-478, which is taken orally once daily, is designed to selectively target the PI3Kα pathway in cancerous but not healthy cells. According to Lilly, this approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability.

Under the terms of the agreement, Lilly will acquire Scorpion and a new entity will be spun out to house Scorpion’s employees and non-PI3Kα pipeline assets. The independent company will be owned by Scorpion’s current shareholders, with Lilly holding a minority equity interest.

Scorpion’s shareholders could receive up to $2.5bn, including an undisclosed upfront payment as well as regulatory and sales milestones.


GSK’s Jemperli granted EC approval in endometrial cancer

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GSK’s Jemperli (dostarlimab) has been granted expanded approval by the European Commission (EC) to treat a broader range of endometrial cancer patients.

The drug has been authorised for use in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

This covers patients with mismatch repair proficient/microsatellite stable tumours, who represent up to 75% of those diagnosed with the disease but were not previously covered by the drug’s EU label.

Endometrial cancer is the most common gynaecological cancer in developed countries, with 417,000 new cases reported globally every year.

GSK’s Jemperli is designed to help the body’s immune system find and attack cancer cells, and is already approved in the EU to treat certain adults with mismatch repair deficient/microsatellite instability-high endometrial cancer.

The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on results from part one of the late-stage RUBY trial, in which Jemperli plus chemotherapy demonstrated a 31% reduction in risk of death compared to chemotherapy alone.


Sanofi’s Sarclisa approved by MHRA for multiple myeloma

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Sanofi’s Sarclisa (isatuximab) has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) as part of a combination treatment for newly diagnosed multiple myeloma (MM).

The regulator has approved the drug for use alongside standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to treat adults who are ineligible for autologous stem cell transplant (ASCT).

Approximately 5,900 cases of MM, an incurable cancer of the blood plasma cells, are diagnosed in the UK every year.

The MHRA’s decision on the quadruplet therapy, which came less than a week after the European Commission approved the combination for the same patient population, was based on results from the phase 3 IMROZ trial.

The trial achieved its primary endpoint, with Sarclisa plus VRd followed by Sarclisa plus lenalidomide and dexamethasone (Rd) reducing the risk of disease progression or death by 40% compared to VRd followed by Rd.

Median progression-free survival (PFS) with the Sarclisa/VRd combination was not reached after a median follow-up of 59.7 months versus 54.3 months with VRd, and the estimated PFS at 60 months was 63.2% for patients receiving Sarclisa/VRd compared to 45.2% for VRd.


Biogen/Eisai’s Alzheimer’s drug approved by FDA for monthly use

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Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab-irmb) has been approved by the US Food and Drug Administration (FDA) for monthly maintenance dosing.

The drug was granted traditional approval in the US in 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage AD.

Eligible patients will now be able to transition to a maintenance dosing regimen of once every four weeks after receiving the drug once every two weeks for 18 months in the initiation phase, or may continue on the bi-weekly schedule.

Leqembi works by reducing clumps of amyloid beta protein that form plaques in the brain. However, AD progression does not stop after plaque clearance, underscoring the importance of ongoing treatment.

The supplemental application submitted by Eisai, which leads Leqembi’s development and regulatory submissions globally, was supported by a range of data, including modelling simulations predicting that changing to monthly maintenance dosing after 18 months will “maintain [the] clinical and biomarker benefits of the therapy”.

It is also hoped that the new regimen will make it easier for patients to continue treatment.

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