Pharmaceutical Market Europe • May 2024 • 6-7
NEWS
Johnson & Johnson (J&J) has announced that it will be expanding its cardiovascular disease (CVD) capabilities by acquiring Shockwave Medical for approximately $13.1bn.
The deal will give the company access to Shockwave’s intravascular lithotripsy (IVL) technology for the treatment of calcified coronary artery disease and peripheral artery disease.
IVL is a minimally invasive, catheter-based treatment for calcified arterial lesions, which can reduce blood flow and cause pain or heart attack.
Shockwave offers the only commercially available IVL technology, J&J outlined, adding that the company has “safely, simply and effectively treated approximately 400,000 patients globally”.
CVD is the leading cause of death globally, resulting in an estimated 17.9 million deaths every year.
Alongside its IVL platform, Shockwave recently acquired Neovasc, with the April 2023 acquisition giving the company access to a product focused on symptom relief for refractory angina. The Reducer System is currently undergoing clinical studies in the US and is CE-marked in the UK and EU.
The latest transaction, which is expected to close by the middle of this year, builds on J&J’s $16.6bn acquisition of heart pump manufacturer Abiomed in 2022.
Takeda and Kumquat Biosciences have entered into a collaboration agreement worth over $1.2bn to advance an oral immune-oncology drug candidate.
The deal gives Takeda an exclusive global licence to develop and commercialise the selected small molecule inhibitor as a monotherapy, combination therapy or both.
Subject to Kumquat’s option, Takeda will assume and fund all development and commercialisation activities following the early-stage trial activities headed by Kumquat.
In exchange, Kumquat will receive up to $130m in near-term payments and will also be eligible for more than $1.2bn if all future clinical, regulatory and commercial milestones are achieved during the term of the agreement, as well as tiered royalties on potential net sales.
Phuong Khanh Morrow, head of the oncology therapeutic area unit at Takeda, said the collaboration “aligns with [the company’s] mission to advance a cutting-edge pipeline focused on maximising the benefit of the immune system to address the continued unmet needs of cancer patients”.
The alliance came less than three months after Takeda and Protagonist Therapeutics announced a worldwide licence and collaboration agreement worth over $300m.
Ipsen and Skyhawk Therapeutics have announced an exclusive worldwide collaboration aimed at advancing RNA-targeting therapies for rare neurological diseases, with the deal worth more than $1.8bn.
The partnership combines Ipsen’s capabilities in neuroscience with Skyhawk’s proprietary drug discovery platform, which “allows for the exploration of previously ‘undruggable’ RNA targets with small molecules”.
Ipsen will have the option to receive exclusive global rights to two candidates pursued under the collaboration and, following development candidate validation, the biopharma will be responsible for further development and commercialisation activities.
In exchange, Skyhawk will be eligible to receive up to $1.8bn in development, regulatory and commercial milestones, including an upfront payment, as well as potential tiered royalties.
Skyhawk says its platform “integrates four distinct and complementary data sets in rapid-growing machine learning models” to accelerate the development of RNA-targeting small-molecule drug candidates across a range of targets.
The announcement came just over three weeks after Ipsen said it had entered into an agreement worth up to $900m to gain exclusive worldwide rights to develop and commercialise Sutro Biopharma’s preclinical antibody-drug conjugate targeting solid tumours.
Pfizer’s antibiotic combination, Emblaveo (aztreonam-avibactam), has been approved by the European Commission (EC) to treat patients with multidrug-resistant infections.
The regulator has specifically authorised Emblaveo for use in adults with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by aerobic Gram-negative bacteria where treatment options are limited.
The decision makes Emblaveo the first beta-lactam/beta-lactamase inhibitor antibiotic combination approved in the EU for the treatment of serious bacterial infections caused by multidrug-resistant Gram-negative bacteria, including metallo-beta-lactamase-producing bacteria.
Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and find ways to resist the effects of antimicrobial drugs.
The EC’s decision on the combination follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by previously reported results from a late-stage programme comprising REVISIT and ASSEMBLE, which evaluated Emblaveo in serious bacterial infections due to Gram-negative bacteria.
Emblaveo was jointly developed with AbbVie, which holds rights to the therapy in the US and Canada.
Cerevel Therapeutics has announced positive phase 3 results for tavapadon as a once-daily treatment for patients living with Parkinson’s disease (PD).
The TEMPO-3 trial has been evaluating the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults with PD.
The double-blind, randomised, placebo-controlled study investigated tavapadon for 27 weeks in 507 adults between the ages of 40 and 80 years with a confirmed diagnosis of PD.
Tavapadon, currently the only selective D1/D5 receptor partial agonist in development for PD, is designed to activate the D1/D5 receptors to potentially provide the right balance of dopamine to improve motor control, safety and tolerability in patients.
The trial met both its primary and secondary endpoints after demonstrating a clinically meaningful and statistically significant increase of 1.1 hours in total ‘on’ time, without dyskinesia in patients treated with tavapadon adjunctive to LD, compared to those treated with LD and placebo, as well as a significant reduction in ‘off’ time.
Additionally, tavapadon was generally well tolerated, with no new safety concerns reported and consistent with prior clinical trials.
Roche has announced positive phase 3 results for its ten-minute subcutaneous (SC) Ocrevus (ocrelizumab) injection in patients with progressive and relapsing forms of multiple sclerosis (MS).
Results from the OCARINA II study were recently presented at the 76th American Academy of Neurology Annual Meeting.
Affecting more than 2.8 million people worldwide, MS is a chronic neurological disease that disrupts the communication between the brain and nerves in the rest of the body.
The most common form of the disease, relapsing-remitting MS, is responsible for 85% of all MS cases.
Results from the trial demonstrated that the SC Ocrevus injection resulted in a 97% suppression of clinical relapses and over 97% in MRI lesions up to 48 weeks in people with relapsing or primary progressive MS and led to rapid and sustained B-cell depletion in the blood.
Additionally, most patients were found to have no T1 gadolinium-enhancing lesions and no new enlarging T2 lesions – markers of active inflammation and burden of disease, respectively – after 48 weeks, with a consistent safety profile of Ocrevus intravenous infusion with no new safety signals identified.