Pharmaceutical Market Europe • January 2024 • 6-7
NEWS
AbbVie expands neuroscience pipeline with $8.7bn Cerevel acquisition
AbbVie has announced that it will be acquiring Cerevel Therapeutics for around $8.7bn, marking a significant boost to the company’s neuroscience pipeline.
The definitive agreement will grant AbbVie access to multiple clinical-stage and preclinical candidates targeting neurological and psychiatric disorders.
This includes tavapadon, a dopamine D1/D5 partial agonist currently in phase 3 testing as a treatment for Parkinson’s disease (PD), which AbbVie says could become “a near-term complementary asset” to its existing symptomatic therapies for advanced cases of the disease due to the candidate’s potential application in early PD.
Emraclidine, a positive allosteric modulator (PAM) of the muscarinic M4 receptor that may be effective in treating schizophrenia and dementia-related psychosis, is also included in the transaction, as well as darigabat, an alpha 2/3/5 selective GABAA receptor PAM for treatment-resistant epilepsy and panic disorder, and CVL-354, a kappa opioid receptor antagonist for major depressive disorder.
Richard Gonzalez, chairman and chief executive officer, AbbVie, said: “Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade.”
The boards of both companies have approved the transaction, which is expected to close in the middle of 2024, subject to Cerevel shareholder approval, regulatory approvals and other customary closing conditions.
Roche to acquire Carmot Therapeutics in deal worth up to $3.1bn
Roche has announced that it will be acquiring Carmot Therapeutics in a deal worth up to $3.1bn, giving the Swiss drugmaker access to a portfolio of incretin-based therapies for diabetes and obesity.
Incretins are gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion and suppressing appetite.
The transaction includes Carmot’s lead asset CT-388, a phase-2 ready dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes.
Roche outlined that the candidate, which is administered as a once-weekly subcutaneous injection, “has potential as a stand-alone and combination therapy to improve weight loss and to be expanded to other indications”.
The US biotech’s pipeline also includes CT-868, a dual GLP-1/GIP receptor agonist in mid-stage development as a once-daily injection to treat type 1 diabetes patients who are overweight or obese, and CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently being evaluated in a phase 1 trial as a treatment for obesity in patients with and without type 2 diabetes.
Under the terms of the agreement, Roche will pay $2.7bn in cash to Carmot equity holders, who will also be eligible to receive milestone payments of up to $400m.
BMS agrees on $8.4bn deal for rights to SystImmune’s ADC candidate
Bristol Myers Squibb (BMS) and SystImmune have announced an exclusive licence and collaboration agreement worth up to $8.4bn for one of SystImmune’s cancer treatments, BL-B01D1.
The bi-specific topoisomerase inhibitor-based antibody-drug conjugate (ADC) targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 and is currently in early-stage development to treat metastatic or unresectable non-small cell lung cancer (NSCLC).
ADCs are a new class of cancer therapies designed to precisely target and kill tumour cells while sparing healthy ones.
Data from earlier clinical studies of the candidate has demonstrated “promising anti-tumour activity” in patients with a range of solid tumours that had progressed after standard of care treatments, including NSCLC and breast cancer, AZ said.
Under the terms of the agreement, the companies will jointly develop and commercialise BL-B01D1 in the US, while SystImmune will retain exclusive rights in mainland China and BMS will gain an exclusive licence in the rest of the world.
In exchange, BMS will pay SystImmune $800m upfront and up to $500m in contingent near-term payments, with SystImmune also eligible to receive additional payments of up to $7.1bn based on the achievement of certain development, regulatory and sales performance milestones.
Novartis’ oral monotherapy approved by FDA for rare blood disease
Novartis’ Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disease affecting approximately ten to 20 people per million worldwide.
PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life.
The disease has a significant unmet need, Novartis reports, with a large proportion of patients on anti-C5 treatment remaining anaemic and dependent on blood transfusions.
Fabhalta is a factor B inhibitor of the immune system’s complement pathway and offers an alternative to therapies that need to be delivered by infusion or injection.
The FDA’s decision on the drug, which applies to both previously treated and treatment-naïve patients, was based on the late-stage APPLY-PNH trial in adults with PNH and residual anaemia despite prior anti-C5 treatment.
Results showed that patients who switched to Fabhalta experienced superior increases of haemoglobin levels over those who continued on anti-C5 treatment.
The approval was also supported by positive results from the phase 3 APPOINT-PNH study in complement inhibitor-naïve patients, Novartis said.
GSK’s Jemperli combination approved by EC for endometrial cancer
GSK’s Jemperli (dostarlimab) has been approved by the European Commission (EC) in combination with carboplatin-paclitaxel (chemotherapy) to treat a subset of patients with primary advanced or recurrent endometrial cancer.
The EC’s decision, which specifically applies to adults whose tumours have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) deficiency mutations and who are candidates for systemic therapy, makes Jemperli the only frontline immuno-oncology treatment approved in the EU for this patient population.
The regulator has also converted its previous conditional marketing authorisation for Jemperli as a monotherapy for certain adults with pre-treated dMMR/MSI-H recurrent or advanced endometrial cancer to full approval.
Endometrial cancer, found in the inner lining of the uterus, is the most common gynaecological cancer in developed countries, with about 417,000 new cases reported globally every year.
GSK’s application supporting the anti-PD-1 therapy’s latest indication is based on positive results from the late-stage RUBY trial, which demonstrated a 72% reduction in the risk of disease progression or death in dMMR/MSI-H patients receiving Jemperli plus carboplatin and paclitaxel compared to chemotherapy alone.
The study also met its second primary endpoint of overall survival, demonstrating a statistically significant and clinically meaningful benefit with the Jemperli-based combination in the trial’s overall patient population.
Eli Lilly’s Jaypirca given FDA accelerated approval for non-Hodgkin lymphomas
Eli Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib) has been given accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).
The regulator’s decision, which marked its second approval of the drug in 2023, specifically applies to adults who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
CLL and SLL are essentially the same diseases that are treated in the same way but are named depending on the location of the patients’ cancer cells. In CLL, the cancer cells are present in the blood and bone marrow, while in SLL, they appear in the lymph nodes.
Lilly’s Jaypirca, which utilises a novel binding mechanism, can extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with these therapies, the company said.
The FDA’s approval of the drug was supported by results from a subset of patients in the phase 1/2 BRUIN trial, in which adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, achieved an overall response rate of 72%.
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