Pharmaceutical Market Europe • November 2023 • 6-7
NEWS
Merck and Daiichi Sankyo’s ADC agreement worth up to $22bn
Merck & Co – known as MSD outside the US and Canada – has agreed to pay Daiichi Sankyo $5.5bn to jointly develop three of its antibody-drug conjugate (ADC) candidates, with the deal potentially worth up to $22bn.
Daiichi Sankyo’s three DXd ADCs – patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd) – are all in various stages of clinical development to treat multiple solid tumours as monotherapies and/or in combination with other treatments.
Patritumab deruxtecan, which has already been granted Breakthrough Therapy Designation by the US Food and Drug Administration, is due to be filed for EGFR-mutated locally advanced or metastatic non-small cell lung cancer in March next year following positive results from the mid-stage HERTHENA-Lung01 trial.
Ifinatamab deruxtecan is currently being evaluated in the phase 2 IDeate-01 study as a treatment option for patients with previously treated extensive-stage small cell lung cancer, while raludotatug deruxtecan is being assessed in a first-in-human phase 1 clinical trial of patients with advanced ovarian cancer.
The companies will jointly develop and potentially commercialise the ADC candidates worldwide, except in Japan, where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply, the companies said.
Roche to acquire Telavant in deal worth over $7.1bn
Roche has entered into a definitive agreement to acquire Telavant from Roivant Sciences and Pfizer for an initial $7.1bn, giving the Swiss drugmaker access to an experimental treatment for inflammatory bowel disease (IBD).
An estimated eight million people worldwide are affected by IBD, a group of chronic gastrointestinal disorders causing symptoms such as persistent diarrhoea and abdominal pain.
Despite the availability of a range of treatments, about 80% of IBD patients do not achieve lasting remission, which can have a long-term impact on quality of life.
Telavant’s RVT-3101 belongs to a class of new treatments known as anti-TL1A antibodies and is currently in development for IBD, including ulcerative colitis and Crohn’s disease.
The candidate was recently evaluated as a treatment option for patients with moderate-to-severe ulcerative colitis in the phase 2b TUSCANY-2 trial, in which RVT-3101 was associated with improved clinical remission in the study’s maintenance stage.
Roche will gain the rights to develop, manufacture and commercialise RVT-3101 in the US and Japan pending clinical and regulatory success and, in addition to the $7.1bn upfront, will pay a near-term milestone payment of $150m.
The company said it is “committed to starting a global phase 3 trial for RVT-3101 as soon as possible”.
Bristol Myers Squibb to acquire Mirati Therapeutics for up to $5.8bn
Bristol Myers Squibb (BMS) has agreed to acquire Mirati Therapeutics for up to $5.8bn, marking a significant boost to the US drugmaker’s oncology portfolio.
The deal gives BMS access to Krazati (adagrasib), which was approved by the US Food and Drug Administration in December to treat adults with KRAS-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
The drug is also currently being evaluated in other indications, including in combination with a PD-1 inhibitor as a first-line treatment for NSCLC and as a monotherapy in previously treated pancreatic cancer.
Alongside Krazati, the transaction includes multiple other targeted oncology assets, such as MRTX1719, which BMS said had shown “encouraging” early efficacy data across several tumour types, including NSCLC and melanoma.
Under the terms of the agreement, BMS will acquire Mirati for $58 per share in cash for a total equity value of $4.8bn.
Mirati stockholders will also receive one non-tradeable contingent value right for each share held, potentially worth $12 per share in cash, representing an additional $1bn of value opportunity.
The announcement came less than a month after BMS revealed plans to double the number of drugs in registrational trials over the next 18 months.
Pfizer’s pentavalent meningococcal vaccine granted FDA approval
Pfizer’s Penbraya has been approved by the US Food and Drug Administration (FDA) as the first pentavalent vaccine that provides protection against the five most common meningococcal serogroups in individuals aged ten to 25 years.
Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and can result in life-altering, significant long-term disabilities for survivors.
Pfizer currently has two vaccines authorised to protect against the disease, with Trumenba targeting meningococcal group B and Nimenrix protecting against groups A, C, W and Y.
Penbraya combines the components from both vaccines and simplifies the meningococcal vaccination schedule by reducing the total number of doses needed to be fully protected against the five serogroups, potentially increasing the number of vaccinated adolescents and young adults.
The FDA’s decision was supported by positive results from mid- and late-stage trials, including a phase 3 study evaluating the safety, tolerability and immunogenicity of Penbraya compared to currently US-licensed meningococcal vaccines.
The US Centers for Disease Control and Prevention, which has noted that combining vaccines may mean that more adolescents and young adults get their recommended vaccines on time, will now meet to discuss recommendations for the appropriate use of Penbraya.
Takeda EC approval for Adcetris combination in Hodgkin lymphoma
Takeda has announced that Adcetris (brentuximab vedotin) has been approved by the European Commission (EC) as part of a combination treatment for adults with previously untreated CD30-positive stage three Hodgkin lymphoma.
The antibody-drug conjugate (ADC), which is already approved in the EU for certain lymphoma patients, can now be used alongside doxorubicin, vinblastine and dacarbazine (AVD) for this subset.
The EC’s latest decision is supported by results from the late-stage ECHELON-1 trial, which compared Adcetris plus AVD to doxorubicin, bleomycin, vinblastine and dacarbazine in more than 1,300 adults with previously untreated stage 3 or 4 Hodgkin lymphoma.
The study met its key primary and secondary endpoints, demonstrating a statistically significant improvement in modified progression-free survival and overall survival in patients treated with the Adcetris combination.
Awny Farajallah, head of global medical affairs oncology at Takeda, said: “These patients now have Adcetris as a treatment option, and the significant improvement in survival outcomes that Adcetris may provide when added to a frontline treatment regimen, as evidenced by the ECHELON-1 clinical trial data.”
Adcetris is being jointly developed by Takeda and Seagen. Under the terms of the agreement, Seagen has US and Canadian commercialisation rights, while Takeda has rights to commercialise Adcetris in the rest of the world.
Biogen/Eisai’s Alzheimer’s disease drug shows promise as subcutaneous formulation
Biogen and Eisai’s Alzheimer’s disease drug has shown promise as a subcutaneous (SC) formulation, according to new data presented by Eisai at this year’s Clinical Trials on Alzheimer’s Disease conference.
The drug, Leqembi (lecanemab-irmb), was granted traditional approval in the US earlier this year for patients with mild cognitive impairment or early-stage Alzheimer’s disease as a bi-weekly intravenous (IV) infusion.
The decision, which made Leqembi the first approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and slow cognitive impairment in the early and mild dementia stages of the disease, was supported by data from the phase 3 Clarity AD clinical trial.
The recent SC sub-study included 72 patients who received Leqembi for the first time as the SC formulation and 322 patients who received the drug’s IV form in the Clarity AD core study followed by SC administration.
The results showed that weekly SC administration of Leqembi removed 14% more amyloid plaque than the approved bi-weekly IV formulation after six months of treatment.
Additionally, blood concentration levels of the drug were 11% higher with SC Leqembi than the IV version.
Eisai said it aims to apply for US approval of SC Leqembi by the end of March 2024.
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