Pharmaceutical Market Europe • April 2025 • 6-7
NEWS
Roche and Zealand agree on $5.3bn obesity partnership
Roche and Zealand Pharma have entered into a partnership worth up to $5.3bn to advance Zealand’s mid-stage obesity candidate petrelintide.
The exclusive collaboration and licensing agreement will see the companies co-develop and co-commercialise the long-acting amylin analogue as both a standalone therapy and as a fixed-dose combination with Roche’s dual GLP-1/GIP receptor agonist CT-388.
Roche gained access to CT-388 in January last year, when it completed its $3.1bn acquisition of Carmot Therapeutics.
Petrelintide is currently in phase 2 development, and available clinical data suggests that the candidate could offer improved tolerability compared to current weight management treatments, the companies said.
The partners will co-commercialise petrelintide in the US and Europe, while Roche will hold exclusive rights to commercialise the drug in the rest of the world.
In exchange, Zealand will receive upfront cash payments of $1.65bn and will be eligible for development milestones of $1.2bn and sales-based milestones of $2.4bn.
Zealand will also pay Roche $350m, off-settable against milestone payments, for the petrelintide/CT-388 fixed-dose combination or next-generation petrelintide combination products being pursued under the collaboration.
AstraZeneca announces
$1bn EsoBiotec acquisition
AstraZeneca (AZ) has announced that it will be expanding its cell therapy capabilities by acquiring EsoBiotec for up to $1bn.
The deal will give AZ access to EsoBiotec’s Engineered NanoBody Lentiviral (ENaBL) platform, which the Anglo-Swedish drugmaker said “could offer many more patients access to transformative cell therapy treatments delivered in just minutes rather than the current process, which takes weeks”.
Traditional cell therapies involve removing cells from a patient, genetically modifying them outside the body, and then giving them back as a medicine after immune cell depletion.
Meanwhile, ENaBL allows cell therapies to be administered directly within the patient’s body through an intravenous injection, without the need for immune cell depletion.
The platform uses lentiviruses to deliver genetic instructions to specific immune cells, programming them to recognise and destroy tumour cells for cancer treatment or autoreactive cells for potential use in immune-mediated diseases.
Under the terms of the agreement, expected to close in the second quarter of 2025, AZ will acquire all outstanding equity of EsoBiotec for up to $1bn, comprising an initial $425m payment and up to $575m in milestones.
Sanofi to acquire Dren’s bispecific for $600m upfront
Sanofi has said it will be broadening its immunology pipeline by acquiring Dren Bio’s phase 1 CD20-directed bispecific myeloid cell engager for $600m upfront.
Preclinical and early clinical studies have already demonstrated DR-0201’s ability to induce robust B-cell depletion via targeted phagocytosis.
Recent data has indicated that deep B-cell depletion might have the potential to reset the body’s adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus.
“Deep B-cell depletion is at the frontier of treating autoimmune diseases and using the myeloid cell engager DR-0201 has the potential to elevate the treatment effect for patients, in particular patients refractory to existing treatments,” said Houman Ashrafian, head of research and development at Sanofi, adding that the acquisition “further strengthens [the company’s] robust pipeline focused on the immune system”.
Under the terms of the agreement, which is expected to close in the second quarter of this year, Sanofi will gain access to DR-0201 by acquiring Dren’s affiliate Dren-0201 for an upfront payment of $600m and potential future milestones totalling $1.3bn.
Merck KGaA’s Mavenclad recommended by NICE for MS
Merck KGaA’s Mavenclad (cladribine) tablets have been recommended by the National Institute for Health and Care Excellence (NICE) to treat a broader group of multiple sclerosis (MS) patients.
NICE has recommended in final draft guidance that the oral therapy be used on the NHS as a first-line treatment option for adults with active relapsing-remitting MS (RRMS) when high-efficacy disease-modifying therapies would be considered.
The drug, which was previously only recommended by NICE as an option for highly active RRMS, a more severe form of the neurological disorder, reduces the frequency of hospital visits and daily treatment requirements.
Affecting more than 150,000 people in the UK, MS occurs when the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
Mavenclad can be taken at home and consists of a maximum of ten days of treatment in the first year and ten days in the second year.
NICE’s latest decision on the drug was supported by clinical and real-world evidence demonstrating that Mavenclad can reduce MS relapse rates, as well as slow disability progression.
Vertex’s cystic fibrosis therapy Alyftrek approved by MHRA
Vertex Pharmaceuticals’ triple combination cystic fibrosis (CF) treatment has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in patients aged six years and older.
Patients eligible for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) will need to have at least one F508del mutation or another mutation in the CF transmembrane regulator (CFTR) gene that has been shown in trials to respond to the therapy.
Over 11,000 people in the UK are affected by CF, a rare inherited disease caused by a faulty CFTR gene, which helps regulate the flow of water and chloride in and out of the lungs and other organs.
Vertex’s Alyftrek is a once-daily oral CFTR modulator that works by correcting the malfunctioning protein made by the CFTR gene.
The MHRA’s decision based on results from two late-stage clinical trials involving 480 CF patients aged 12 years and over.
Alyftrek was shown to be as effective at improving lung function as Vertex’s currently approved triple combination therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor), and more effective at reducing sweat chloride levels.
Additional data from an open label phase 3 study also supported the approval.
BMS’ Breyanzi granted EC approval for follicular lymphoma
Bristol Myers Squibb (BMS) has received approval from the European Commission (EC) for its CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) in follicular lymphoma (FL).
The drug, which is already approved in the EU for certain lymphomas, is now authorised to treat relapsed or refractory FL in adults who have received at least two prior lines of systemic therapy.
FL, which develops when white blood cells cluster together to form lumps in the lymph nodes or organs, accounts for up to 30% of non-Hodgkin lymphoma cases.
Breyanzi is made from patients’ own T cells, which are collected and genetically re-engineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
The EC’s decision follows a recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 2 TRANSCEND FL study, which demonstrated an overall response rate of 97.1% and a complete response rate of 94.2%, the trial’s primary and key secondary endpoints, respectively.
Responses were rapid and durable, BMS said, with 75.7% of patients still in response at 18 months.
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