Privately held Aspect Biosystems Ltd. and Novo Nordisk A/S will collaborate to develop up to four diabetes and/or obesity products using implantable bioprinted tissues to replace, repair or supplement human biological functions. Aspect is getting an initial $75 million, which includes an up-front payment and money for research. Aspect also could receive up to $650 million dollars in development, regulatory, commercial and sales milestones per product, plus tiered royalties on future product sales, which could bring the company $2.6 billion. In return, Novo, which already has big-selling diabetes treatments Ozempic and Rybelsus, gets an exclusive, worldwide license to use Aspect’s technology in developing the products.
Biopharma deals slip in Q1, as completed M&As remain low
Despite strong deal activity throughout each of the last two years, the volume and value of partnerships began sliding in the first quarter (Q1) of 2023, while M&As continue to trail several other years. With less attention focused on the COVID-19 pandemic, and with the challenging public markets and the high cost of capital, deals and M&As remain a strong option for biopharma companies trying to advance key products and platforms. The industry continues to record mega-deals, those worth $1 billion and more, and oncology remains a top focus. A total of 357 biopharma deals were completed in Q1, with a combined value of $48.1 billion. This is a 16% drop from last year. The number of M&As completed in Q1 hit 34 worth a combined $8.98 billion, which is only 56% of the amount raised in 2022’s Q1.
Improved dialogue with pharma on agenda as EMA seeks to enhance Prime scheme
Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval. The EMA has proposed the “submission readiness meetings” in order to prevent delays processing applications for accelerated assessments and to strengthen engagement between itself and drug developers, after it found more than half (about 56%) of applications revert to standard approval timetables, thereby slowing the access of drugs designed to address unmet needs to patients.
Adcom briefing documents pass trials for Otsuka, Lundbeck’s Rexulti in AD agitation
A joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee on April 14 will take up the matter of Rexulti (brexpiprazole) for agitation in patients with Alzheimer’s disease (AD) dementia. The drug, from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S, is a serotonin-dopamine activity modulator for schizophrenia and the adjunctive treatment of major depressive disorder. Rexulti gained its first approval in the summer of 2015. Briefing documents related to the adcom praised “three adequate and well-controlled trials” backing the application in AD. Safety findings were deemed “generally consistent” with Rexulti’s known profile.
Immutep’s LAG-3 efti plus pembrolizumab extends efficacy in NSCLC
Immutep Ltd.’s lead immunotherapy candidate, eftilagimod (IMP-321, efti), plus pembrolizumab reverted previous resistance to PD-1/PD-L1 therapy in part B of the TACTI-002 phase II trial in second-line metastatic non-small-cell lung cancer (NSCLC) in patients refractory to anti-PD-1/PD-L1 therapy. Immutep reported in November 2022 that efti combined with Keytruda (pembrolizumab, Merck & Co. Inc.) met the primary endpoint in first-line NSCLC, showing an overall response rate of 40.4%. The TACTI-002 all-comer trial enrolled more than 180 patients in Europe, the U.S. and Australia and included patients with all levels of PD-L1 expression. About 99.1% had metastatic disease, and more than 75% had PD-L1 status of less than 50%, with 34% completely negative for PD-L1.
With clock ticking, FDA seeks longer hold on abortion drug order
With a Saturday deadline looming, the U.S. Court of Appeals for the Fifth Circuit is being asked to intervene immediately to keep mifepristone on the U.S. market as an abortion option while legal challenges continue to play out in court. In handing down a nationwide order last week staying the FDA’s approval of Danco Laboratories LLC’s abortion drug Mifeprex (mifepristone) and generics, a federal judge in Texas put the decision on hold for one week to give the Biden administration time to file an appeal. Subsequently, the FDA, Department of Health and Human Services and Danco have filed a motion with the appellate court asking it to extend that hold, by noon April 13, throughout the appeals proceedings in the Fifth Circuit and, if necessary, the Supreme Court.