Pharmaceutical Market Europe • June 2025 • 6-7
NEWS
BMS and BioNTech agree on $11bn oncology partnership
Bristol Myers Squibb (BMS) has entered into an agreement worth over $11bn to jointly develop and commercialise BioNTech’s investigational bispecific antibody across solid tumour types.
The candidate, BNT327, is being evaluated in multiple clinical trials, including phase 3 studies in first-line stage small cell lung cancer and non-small cell lung cancer. A late-stage trial in first-line triple negative breast cancer is also expected to begin this year.
The drug is directed at PD-L1 and VEGF-A, two well-established therapeutic targets, and aims to help normalise blood vessels at the tumour site, improving delivery and the effectiveness of combination therapies. Preliminary data from ongoing trials has already “[underscored] the potential” of the approach, the companies outlined.
The global agreement will see the partners co-develop and co-commercialise BNT327, including as a monotherapy and in combination with other products. Both companies will have the option to independently develop the candidate in further indications and combinations.
In exchange, BMS will pay BioNTech $1.5bn upfront and $2bn in non-contingent anniversary payments, with BioNTech also eligible to receive up to $7.6bn in additional development, regulatory and commercial milestones.
Pfizer and 3SBio in $6bn licensing agreement
Pfizer will be gaining exclusive rights to 3SBio’s investigational PD-1 and VEGF-targeted bispecific antibody in a deal worth over $6bn.
The candidate, SSGJ-707, is being evaluated in several clinical trials in China as a treatment for metastatic colorectal cancer, non-small cell lung cancer and gynaecological tumours.
The drug has already demonstrated initial efficacy and safety data in a “promising class” of cancer medicines, Pfizer said, adding that 3SBio is planning to launch the first phase 3 study of the asset in China this year.
The agreement will see 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical and 3S Guojian Pharmaceutical grant Pfizer an exclusive licence to develop, manufacture and commercialise SSGJ-707 everywhere except China. The drugmaker will also be given the option of commercialisation rights in China.
In exchange, 3SBio will receive $1.25bn upfront from Pfizer and will be eligible for certain development, regulatory and commercial milestone payments of up to $4.8bn, as well as royalties on potential future sales.
Pfizer is also set to make a $100m equity investment in 3SBio when the transaction closes, expected in the third quarter of 2025.
Sanofi to acquire Blueprint Medicines in $9.5bn deal
Sanofi has announced that it will be expanding its immunology capabilities by acquiring US-based Blueprint Medicines Corporation in a deal worth up to approximately $9.5bn.
The acquisition will grant Sanofi access to Ayvakit/Ayvakyt (avapritinib), the only approved medicine for advanced and indolent forms of the rare immunologic disorder systemic mastocytosis (SM).
Approximately one in 10,000 people in the UK are thought to be affected by SM, with indolent forms accounting for the majority of cases.
SM is caused by the abnormal build-up of mast cells, a key part of the body’s immune system. Patients can experience symptoms such as skin lesions, diarrhoea, bone pain, fatigue and anaphylaxis, and the disease can lead to organ damage, anaemia and bone fractures.
Blueprint’s avapritinib works by targeting KIT D816V, the primary underlying cause of the disease.
Alongside the drug, the deal will give Sanofi access to an advanced and early-stage immunology pipeline. This includes elenestinib, an oral KIT D816V inhibitor for SM, and BLU-808, an oral wild-type KIT inhibitor that has the potential to treat a broad range of inflammatory diseases.
Eli Lilly’s Omvoh recommended by NICE for Crohn’s disease
Eli Lilly’s Omvoh (mirikizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat moderately to severely active Crohn’s disease.
The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in England and Wales to treat adults whose disease has not responded well enough or stopped responding to a previous biological treatment, not tolerated a previous biological treatment, or been unsuitable for tumour necrosis factor-alpha inhibitors.
Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects more than 500,000 people in the UK.
Lilly’s Omvoh is already recommended by NICE for ulcerative colitis, another of the two main forms of IBD, and is designed to reduce inflammation within the gastrointestinal tract.
NICE’s latest decision came less than two months after the Medicines and Healthcare products Regulatory Agency approved Omvoh for use in the UK and was based on data from the late-stage VIVID-1 study.
Results showed that 45% of Omvoh-treated patients achieved clinical remission at one year, compared to 20% of those receiving placebo.
Takeda granted MHRA approval for rare blood clotting disorder therapy
Takeda’s Adzynma (rADAMTS13) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat congenital thrombotic thrombocytopenic purpura (cTTP).
The enzyme replacement therapy, which has been authorised to treat patients of all ages, is now the first treatment approved in the UK for the ultra-rare blood clotting disorder.
cTTP is an inherited condition caused by a deficiency in an enzyme critical to blood clotting. Patients can experience a variety of symptoms and severe complications, including thrombocytopenia, stroke, and renal and cardiovascular disease.
The MHRA’s decision on Adzynma occurred through the International Recognition Procedure and follows the European Commission’s approval of the therapy in August.
Among the evidence supporting the EU authorisation were results from a phase 3 trial showing that no patient experienced an acute thrombotic thrombocytopenic purpura (TTP) event while receiving Adzynma as a preventative treatment, while there was one acute TTP event in a patient receiving plasma-based therapies.
Additionally, one subacute TTP event was seen in the Adzynma cohort during periods one and two of the study, versus seven subacute TTP events in six patients receiving plasma-based therapies.
AbbVie’s Emrelis approved by FDA for lung cancer
AbbVie’s Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of lung cancer patients.
The c-Met-directed antibody-drug conjugate has been authorised to treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) in adults who exhibit high overexpression of the c-Met protein and have previously received systemic therapy.
An estimated 226,650 people will be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 85% of all cases.
Approximately 25% of patients with advanced EGFR wild type, non-squamous NSCLC exhibit c-Met protein overexpression, which is linked with a poor prognosis, and around half of these patients have high c-Met overexpression.
The approval was supported by results from the mid-stage LUMINOSITY trial, in which Emrelis was associated with a 35% overall response rate and median duration of response of 7.2 months in patients with high c-Met protein overexpression.
Alongside its decision on Emrelis, the FDA has approved Roche’s VENTANA MET (SP44) RxDx Assay as a companion diagnostic test to help detect c-Met protein overexpression in patients.
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