Almirall has entered into a collaboration and licensing agreement with Shanghai Huaota Biopharmaceutical, a subsidiary of Zhejiang Huahai Pharmaceutical.

The joint research and development programme aims to advance a monoclonal
antibody candidate for potential applications across multiple indications,
including medical dermatology.

To deliver the programme to clinical proof-of-concept, Huaota will use its biologics R&D platform to lead early research activities and the initial stages of clinical development.

Outside China, Almirall will hold global development and commercialisation rights, with Huaota holding the rights for China.

Almirall will pay Huaota up to $340m, including upfront and milestone payments, as well as tiered royalties on future net sales. Huaota will also pay Almirall tuered royalties based on future sales in China.

Almirall recently opened new offices in China to identify local R&D programmes, with the new partnership building on this pre-existing footprint.

The company is focused on using its end-to-end expertise to meet China’s growing demand for advanced treatments in medical dermatology.

In 2022, Almirall agreed on a collaboration with Chinese company Simcere to progress a preclinical-stage drug candidate for autoimmune diseases.

Arcutis Biotherapeutics has published data from the phase 3 open-label extension (OLE) study (INTEGUMENT-OLE) evaluating Zoryve (roflumilast) in children aged two to five years with mild-to-moderate atopic dermatitis.

Published in Pediatric Dermatology, the results showed Zoryve cream 0.05% is
safe, well tolerated and is had an improving efficacy with up to 56 weeks of treatment.

A once-daily cream, Zoryve is a prescribed branded topical therapy used across three
major dermatoses.

Affecting approximately 9.6 million children in the US, atopic dermatitis is the
most common type of eczema.

The more recent data builds on results from the four-week phase 3 INTEGUMENTPED trial, which established the efficacy and safety of Zoryve cream 0.05% in this paediatric population.

INTEGUMENT-OLE involved participants aged between two and five years old with
mild-to-moderate atopic dermatitis who have previously received Zoryve cream 0.05% or vehicle cream in the INTEGUMENT-PED study.

During the OLE safety trial, which lasted 52 weeks, all participants received Zoryve cream once daily. Children who achieved clear skin after week 4 moved to a twice weekly (BIW) regimen, with the published results containing data from both treatment regimens.

The US FDA is reviewing a supplemental Biologics License Application (sBLA) from Sun Pharmaceutical industries (Sun Pharma) for Ilumya (tildrakizumab), a potential treatment for adults with active psoriatic arthritis (PsA).

The sBLA is based on results from the INSPIRE-1 and INSPIRE-2 phase 3 clinical studies that evaluated the efficacy and safety of the treatment in adult patients with active PsA.

Causing swelling, pain and stiffness, PsA affects up to 2.4 million Americans and roughly one in three people living with psoriasis.

Ilumya is a humanised IgG1/k monoclonal antibody that inhibits the release of pro-inflammatory cytokines and chemokines.

Through five years of clinical follow-up, Ilumya has a well-characterised safety profile. Real-world experience also shows a strong adherence and persistence, which helps patients to stay on the treatment long term.

The FDA regulatory action date for this sBLA is expected by 29 October 2026, and approval would mark a new indication for the treatment, after Ilumya was approved by the US FDA in 2018 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.