Pharmaceutical Market Europe • September 2025 • 6-7
NEWS
Merck to acquire
Verona for around $10bn
Merck & Co – known as MSD outside of the US and Canada – has announced that it will be expanding its respiratory diseases capabilities by acquiring Verona Pharma for approximately $10bn.
The deal will give Merck access to Ohtuvayre (ensifentrine), an inhaled therapy already approved by the US Food and Drug Administration as a maintenance treatment for adults with chronic obstructive pulmonary disease (COPD).
More than 390 million people worldwide are living with COPD, a progressive respiratory condition that causes restricted airflow and breathing problems.
Ohtuvayre is a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4, and combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
Among the evidence supporting the FDA’s approval of the drug were results from the late-stage ENHANCE trials, in which Ohtuvayre was associated with clinical benefits as both a monotherapy and when used with other maintenance therapies.
Beyond COPD, the drug is currently in clinical development for non-cystic fibrosis bronchiectasis.
Under the terms of the agreement, expected to close in the fourth quarter of this year, Merck will acquire Verona Pharma for $107 per American Depository Share.
Sanofi expands respiratory vaccines pipeline with $1.6bn Vicebio deal
Sanofi has announced that it will be expanding its respiratory vaccines pipeline by acquiring UK-based Vicebio for up to $1.6bn.
The deal will give the French group access to an early-stage combination vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), two leading causes of lower respiratory tract infections.
The acquisition will also include a preclinical trivalent vaccine candidate targeting RSV, hMPV and parainfluenza virus type 3 (PIV3), as well as Vicebio’s ‘Molecular Clamp’ technology, which is designed to stabilise viral proteins in their native shape and allow the immune system to recognise and respond to them more effectively.
The Molecular Clamp approach accelerates the development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures and made available in pre-filled syringes, simplifying the manufacturing and distribution process while enhancing ease of use.
The agreement, expected to close in the final quarter of this year, will see Sanofi acquire all of Vicebio’s share capital for $1.15bn upfront, with the deal also including potential milestone payments of up to $450m, based on development and regulatory achievements.
AbbVie and IGI in oncology and autoimmune diseases deal worth $1.9bn
AbbVie will be gaining rights to IGI Therapeutics’ lead candidate for oncology and autoimmune diseases in an exclusive licensing agreement worth over $1.9bn.
ISB 2001 is a trispecific T-cell engager currently in phase 1 clinical development for relapsed or refractory cases of multiple myeloma, an incurable blood cancer affecting more than 36,000 people in the US every year.
AbbVie will receive exclusive rights to develop, manufacture and commercialise the drug across Europe, North America, Japan and Greater China.
In exchange, the Ichnos Glenmark Innovation subsidiary will receive $700m upfront and will be eligible for up to $1.225bn in milestone payments, as well as royalties on net sales.
Developed using IGI’s proprietary BEAT protein platform, ISB 2001 targets BCMA and CD38 on myeloma cells and CD3 on T cells.
Phase 1 data presented at this year’s American Society of Clinical Oncology annual meeting showed that the candidate demonstrated a sustained overall response rate of 79% and a high complete/stringent complete response rate of 30% at active doses of at least 50µg/kg in patients with heavily pretreated relapsed/refractory myeloma.
Roche’s Itovebi granted EC approval for breast cancer
Roche’s oral PI3K inhibitor Itovebi (inavolisib) has been approved by the European Commission (EC) as part of a combination treatment for advanced breast cancer patients.
The drug has been authorised for use alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and AstraZeneca’s hormone therapy Faslodex (fulvestrant) in adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
Patients will be eligible for the combination following disease recurrence on or within 12 months of completing adjuvant endocrine treatment.
ER-positive breast cancer is a subtype of hormone receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases.
The EC’s decision was supported by results from the late-stage INAVO120 trial, in which the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone in the first-line setting, with this benefit consistent across all pre-specified subgroups.
The triplet therapy also reduced the risk of death by 33% and delayed the time to chemotherapy by approximately two years compared with Ibrance and Faslodex alone.
Vertex’s cystic fibrosis therapy recommended by NICE
Vertex Pharmaceuticals’ triple combination cystic fibrosis (CF) therapy has been recommended by the National Institute for Health and Care Excellence (NICE) to treat patients aged six years and older.
The health technology assessment agency has recommended in final draft guidance that the once-daily drug, Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), be used on the NHS to treat CF patients who have at least one F508del mutation or another responsive mutation in the CF transmembrane conductance regulator (CFTR) gene.
Approximately 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 into and out of the cells in a number of organs.
Vertex’s Alyftrek works by correcting the malfunctioning protein made by the CFTR gene, helping patients live more independently and reducing the time they need to spend in hospital.
NICE’s decision was supported by clinical evidence showing that Alyftrek was 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.
Regeneron’s Lynozyfic approved by FDA for multiple myeloma
Regeneron Pharmaceuticals’ bispecific antibody Lynozyfic (linvoseltamab-gcpt) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory multiple myeloma (MM).
Patients eligible for the drug will have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody.
More than 36,000 new cases of MM, an incurable blood cancer, are expected to be diagnosed in the US this year.
Despite advances in treatment, there are around 8,000 MM patients in the US whose disease has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies.
The FDA’s decision on Lynozyfic was based on results from the phase 1/2 LINKER-MM1 trial, which demonstrated a 70% objective response rate and complete rate of 45%.
Median time to first response was 0.95 months, while median duration of response (DoR) was not reached. Estimated DoR was 89% at nine months and 72% at 12 months among responders who had a median follow-up of 13 months.
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