News

Small and medium-sized enterprises (SMEs) saw a 33% increase in the success rate for their marketing authorisation applications in 2023, according to a new report by the European Medicines Agency. SMEs are broadly defined as companies with a staff headcount of between 10 and 250 people and a turnover ranging from less than €2 million to up to €50 million. Despite their small size, they represent the backbone of the European life science industry with activity in nine distinctive sectors. There were 1,925 registered SMEs on 31 December 2023. 

France-based SparingVision SA, which is developing gene therapies for retinal diseases, has presented data from an ongoing natural history study of rod-cone dystrophy showing the structural features of the disease and identifying a subset of patients with a higher rate of disease progression. This is to inform the company’s development of an ocular gene therapy for the disease which is in a separate Phase 1/2 trial in patients for severe rod-cone dystrophy.

The following article gives the 2024 financial outlook for a selection of European biopharma companies ranging in size from multinational groups to smaller companies

The US Food and Drug Administration has approved a new treatment for uncomplicated urinary tract (UTI) infections in women. Approximately one-half of all women experience at least one type of infection at least once in their lifetime. The drug, Pivya (pivmecillinam) is a narrow spectrum antibiotic which has been shown to be effective against infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Commit Biologics ApS was launched in Denmark on 9 May with seed funding of €16 million to use a proprietary platform to develop new drugs for cancer and autoimmune diseases. The seed funding was provided by Bioqube Ventures and Novo Holdings. Commit is a spin-out from Aarhus University in Denmark and was initially incubated by the country’s BioInnovation Institute.

UK based Pheon Therapeutics Ltd has secured $120 million in a Series B financing round to support the development of antibody-drug conjugates (ADCs). These are drugs that use an antibody to deliver a toxic payload directly to a cancer cell and kill the cancer in situ. The financing was led by TCGX of the US and other new investors including BVF Partners, Lightspeed and Perceptive Advisors. Four existing investors also participated in the round. They were Atlas Venture, Brandon Capital, Forbion, and Research Corporation Technologies.

ADC Therapeutics SA of Switzerland reached agreement with investors on 6 May to sell shares and warrants valued at $105 million to support its portfolio of antibody-drug conjugates for cancer. The new financing will lengthen the company’s cash runway enabling it to advance new indications for Zynlonta (loncastuximab tesirine), a marketed drug, and clinical-stage assets in its portfolio. ADC is developing antibody-drug conjugates for both haematological cancers and solid tumours. On 31 March it had cash and cash equivalents of $234.3 million compared with $278.6 million on 31 December 2023.

A gene therapy being developed by Regeneron Pharmaceuticals Inc has enabled a young child, suffering from a congenital hearing loss, to overcome deafness. The child, dosed at 11 months of age, is one of two to have responded to the experimental therapy which uses gene replacement to address mutations in the OTOF gene – the cause of the disease. A second child, who received the therapy at the age of four, showed initial improvements after dosing.

BioVersys AG, a Swiss antibiotic developer, has expanded a collaboration with GSK Plc to accelerate development of a candidate product for tuberculosis. The product, alpibectir, has reached Phase 2a and shown an ability to increase the efficacy of ethionamide, an existing antibiotic. GSK will take an equity stake in a Series C financing extension for the company, raising the total proceeds from the round to CHF 44.9 million ($49.4 million). The size of the equity stake wasn’t disclosed. The new agreement was announced on 7 May.

A new gene therapy company with plans to start clinical development of its first product has raised $54 million in a Series A financing round. Latus Bio Inc is a spin-out of the Children’s Hospital of Philadelphia, US, with a new technology for producing adeno-associated viral vectors, one of the most common vectors in use for gene therapies. Announced on 2 May, the financing round was led by 8VC of Texas and DCVC Bio of California.