Pharmaceutical Market Europe • April 2024 • 6-7

NEWS

Gilead and Merus announce oncology partnership worth over $1.5bn

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Gilead Sciences and Merus have announced a new oncology partnership worth over $1.5bn to discover dual tumour-associated antigens targeting trispecific antibodies.

The collaboration combines Gilead’s oncology capabilities with Merus’ Triclonics platform, which “provides the unique opportunity to design antibodies capable of simultaneously binding to three targets at once,” according to the companies.

Under the terms of the agreement, Merus will lead early-stage research activities for two programmes, with the potential for a third. If Gilead exercises its right to license any resulting programmes, it will be responsible for additional research, development and commercialisation activities.

In exchange, Merus will receive an upfront cash payment of $56m for initial targets and a $25m equity investment from Gilead, with the company also eligible for up to $1.5bn in milestone payments across all the potential programmes and tiered royalties.

For the third potential programme, Merus can opt-in to share an equal split of net profits and losses rather than future milestone and royalty payments.

The announcement came less than one month after Gilead said it would be acquiring CymaBay Therapeutics for $4.3bn.


AstraZeneca acquires Amolyt Pharma for $1.05bn

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AstraZeneca (AZ) has announced that it will be expanding its rare disease unit’s late-stage pipeline by acquiring Amolyt Pharma for more than $1bn.

The deal will build on Alexion’s bone metabolism franchise with the addition of eneboparatide (AZP-3601), a late-stage investigational therapeutic peptide currently being evaluated as a treatment for hypoparathyroidism.

Affecting an estimated 107,000 people in the EU, approximately 80% of whom are women, hypoparathyroidism is a rare condition defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood.

Eneboparatide is a PTH receptor 1 agonist with “a novel mechanism of action rationally designed to meet the therapeutic goals of hypoparathyroidism,” the company said.

Under the terms of the agreement, which is expected to close in the third quarter of this year, AZ will acquire all of Amolyt’s outstanding shares for a total consideration of up to $1.05bn.

This includes an upfront payment of $800m plus the right for Amolyt shareholders to receive an additional contingent payment of $250m payable upon achievement of a specified regulatory milestone.


Ipsen agrees $900m licensing agreement with Sutro Biopharma

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Ipsen has entered into an agreement worth up to $900m to gain exclusive worldwide rights to develop and commercialise Sutro Biopharma’s preclinical antibody-drug conj ugate (ADC) targeting solid tumours.

ADCs are a new class of cancer therapies designed to precisely target and kill tumour cells while sparing healthy ones.

Sutro’s STRO-003, which will be the first ADC candidate to be added to Ipsen’s portfolio, targets a tumour antigen that is known to be overexpressed in many different cancer types, including solid tumours and haematological malignancies.

Mary Jane Hinrichs, senior vice president and head of early development at Ipsen, said: “The potential for ADCs in oncology is well documented and we are excited by the addition of STRO-003...”

Under the terms of the agreement, Ipsen will assume responsibility for phase 1 preparation activities for the asset, such as the submission of an Investigational New Drug application, and all subsequent clinical-development activities and global commercialisation activities.

In exchange, Sutro will be eligible to receive up to $900m in potential upfront, development, regulatory and commercial milestone payments, including approximately $90m in near-term payments, and tiered royalties on global sales.


Pfizer’s antibiotic combination recommended by CHMP

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Pfizer’s antibiotic combination, Emblaveo (aztreonam-avibactam), has been recommended by the European Medicines Agency’s human medicines committee to treat infections caused by multidrug-resistant bacteria.

The Committee for Medicinal Products for Human Use (CHMP) has recommended that Emblaveo be used in adults with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria where treatment options are limited.

Declared by the World Health Organization as one of the top ten threats to global public health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time.

The CHMP’s decision was supported by safety and efficacy data already available for each active substance and positive results of two phase 3 randomised studies, REVISIT and ASSEMBLE, which evaluated Emblaveo in serious bacterial infections due to Gram-negative bacteria.

If approved, Emblaveo would be the first beta-lactam/beta-lactamase inhibitor combination for treating serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including metallo-beta-lactamase-producing bacteria, authorised for use in the EU.

Emblaveo was jointly developed with AbbVie, which holds rights to the therapy in the US and Canada.


J&J’s Rybrevant approved by FDA for non-small cell lung cancer

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Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) has been approved by the US Food and Drug Administration (FDA) to treat a subset of non-small cell lung cancer (NSCLC) patients.

The bispecific antibody is now approved for use alongside carboplatin and pemetrexed chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant has also been granted traditional approval to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, upgrading the FDA’s May 2021 accelerated approval for the drug in this indication.

NSCLC accounts for up to 85% of all lung cancer cases worldwide and alterations in EGFR are the most common actionable driver mutations in NSCLC.

The FDA’s latest decisions on the drug are supported by positive results from the late-stage PAPILLON study, in which Rybrevant plus chemotherapy was associated with a 61% reduction in the risk of disease progression or death compared to chemotherapy alone.

Results also showed treatment with Rybrevant plus chemotherapy improved objective response rate and progression-free survival.


GSK’s Jemperli combination recommended by NICE for endometrial cancer

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GSK’s Jemperli (dostarlimab) has been recommended by the National Institute for Health and Care Excellence (NICE) in combination with platinum-containing chemotherapy as a first-line treatment for a subset of advanced endometrial cancer patients.

NICE’s final draft guidance specifically applies to adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) deficiency primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The agency’s decision comes around two years after Jemperli was made available in England via the Cancer Drugs Fund as monotherapy following platinum-based chemotherapy for patients with dMMR or MSI-H endometrial cancer.

There are approximately 2,770 people diagnosed with advanced or recurrent disease in England, Wales and Northern Ireland each year, and about 580 will now be eligible for treatment with Jemperli.

GSK’s application supporting the PD-1 inhibitor’s latest indication was supported by positive results from the late-stage RUBY trial, which demonstrated a more than 70% reduction in the risk of disease progression or death in dMMR and MSI-H patients receiving Jemperli plus carboplatin and paclitaxel relative to chemotherapy alone, as well as benefits in overall survival.

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