Optimum’s clients shine in major mergers, approvals and awards in ‘24
2024 has been a phenomenal year for Optimum and its clients, with some spectacular successes both in and out of the clinic.
Here are some of the highlights from a year that saw the life sciences industry get back on track after some challenging times.
M&A Deals
There was great news for Calliditas Therapeutics, one of Optimum’s longest-standing clients, when it announced its US$1.1 billion acquisition by Asahi Kasei. Just seven years ago, the Swedish biotech had fewer than a dozen staff.
Novo Holdings’ and Sofinnova portfolio company Amolyt Pharma was acquired by AstraZeneca for US$1.05 billion in one of the most eye-catching deals of 2024. Novo Holdings was Amolyt’s largest investor.
Sofinnova made some waves when its portfolio company Shockwave Medical was acquired by Johnson & Johnson for US$13.1 billion.
Novo Holdings’ portfolio company Invetx, a pioneer in novel, protein-based animal therapeutics, announced an agreement to be acquired by Dechra Health, the animal health specialist, for up to US$520 million.
Novo Holdings completed its acquisition of Catalent, a leader in enabling the development and supply of better treatments for patients worldwide, in an all-cash transaction with a total enterprise value of approximately $16.5 billion. In connection with the transaction, Novo Holdings will sell three of Catalent’s nearly 50 global sites to Novo Nordisk A/S.
Approvals
Sequana Medical announced US FDA Approval of alfapump for treatment of recurrent or refractory ascites due to liver cirrhosis.
With this major regulatory milestone, achieved earlier than market expectations, alfapump is the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder.
Ariceum Therapeutics announced it had received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 clinical trial (CITADEL-123) of 123I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with the brain cancer recurrent glioblastoma.
Calliditas’ partner STADA received full approval from the European Commission for Kinpeygo (budesonide) for treatment of adults with primary immunoglobulin A nephropathy.
BrightHeart, a leading AI innovator in obstetric and paediatric cardiology technology and portfolio company of client Sofinnova Partners, announced it had received FDA 510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the foetal heart.
Neuraxpharm Group, a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announced that NICE in the UK had issued a positive recommendation for the use of Briumvi (ublituximab) in the treatment of relapsing-remitting multiple sclerosis (RRMS).
Adcendo, a biotech company focused on the development of first-in-class ADCs for the treatment of cancers with a high unmet medical need, announced that the FDA has provided clearance of the IND application for the Phase I/II study of ADCE-D01 in patients with metastatic and/or unresectable STS (the ADCElerate-01 Trial).
Antag Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor AT-7687 antagonist. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects.
Resolution Therapeutics has clearance from the UK’s Medicines and Healthcare products Regulatory Agency and the Spanish Agency of Medicines and Medical Products to investigate safety and efficacy of engineered macrophage cell therapy in patients with decompensated liver cirrhosis.
SpliceBio, a genetic medicines company pioneering Protein Splicing to address diseases caused by mutations in large genes, announced that the U.S. Food & Drug Administration (FDA) has cleared its investigational new drug (IND) application for lead program SB-007. SB-007 is the only clinical-stage therapeutic addressing the root genetic cause of Stargardt disease with the potential to treat all patients across all ABCA4 mutations.
Awards
STORM Therapeutics Ltd. announced that Tony Kouzarides, PhD, FMedSci, FRS, its Founder & Director, who is also Professor of Cancer Biology at Cambridge University, was to be honoured with a knighthood for his global impact on disease treatment.
Renée Aguiar-Lucander, former CEO of Calliditas Therapeutics, scooped the prestigious Executive of the Year Award – Commercial Stage Companies, at the Scrip Awards 2024. Renée led the company through clinical development of Tarpeyo (budesonide), its lead product to treat the rare disease IgA Nephropathy, to a successful U.S. approval and launch. Calliditas’ Tarpeyo was nominated for best new drug.
Renée also picked up the Public Company CEO of the year at the European Lifestars Awards.
Also at Lifestars DISCO Pharmaceuticals picked up Seed Stage Finance Raise of the Year, while Myricx won Series A Finance Raise of the Year for its £90 million (US$114 million) fundraiser. Novo Holdings scooped Venture Capital Firm of the Year, Sofinnova Partners’ portfolio company Moon Surgical won Medtech Company of the Year, while Barbara Angehrn Pavik, CEO of Asceneuron won private company CEO of the Year.
What a busy 2024 it has been! Wishing you a Merry Christmas and Happy New Year. 2025 is shaping up to be a classic.
Continue reading Optimum’s 2024 year in review with the research and financing editions!
