H. Lundbeck A/S scored two important regulatory goals in April and May, just weeks after closing its books for the first quarter, a period during which it produced its highest three-month revenue figure ever. Revenue was DKK 5 billion (€670 million) for the period, up by 15% from a year earlier.
DiogenX SAS of France has raised €27.5 million in Series A finance from a venture capital syndicate led by the Boehringer Ingelheim Venture Fund and Roche Venture Fund to advance a candidate drug for type 1 diabetes into clinical development. The drug is a recombinant protein that modulates the Wnt/beta-catenin signalling pathway, a regulator of key cellular functions. In preclinical studies it has shown an ability to regenerate insulin-producing beta cells, according to Johannes Zanzinger, investment director at the Boehringer Ingelheim fund.
Ariceum Therapeutics GmbH is to work with the Belgian pharma company UCB SA to discover new radiotherapeutics for the treatment of cancer and immune-related disorders. Announced on 11 May, the agreement follows a decision by Ariceum’s investors to provide a further €22.75 million in capital to the company to progress its pipeline.
Swedish Orphan Biovitrum AB (Sobi) is to pay $1.7 billion to acquire a company that will expand its presence in drugs for rare haematological diseases. It is the Swedish company’s biggest deal to date. The target company is CTI BioPharma Corp of Seattle, US which has a recently approved product for adult patients with myelofibrosis and thrombocytopenia, a condition that occurs when the platelet count in the blood is too low.
The World Health Organization has declared an end to the emergency phase of Covid-19, but cautioned that risks still remain for the appearance of new variants of the SARS-CoV-2 virus. In a statement on 5 May, Tedros Adhanom Ghebreyesus, the WHO director general, said Covid-19 will no longer be categorised as a public health emergency of international concern. But its status as a pandemic will remain until these risks diminish.
Going forward, the pandemic “appears to be in transition to a more endemic situation globally,” the WHO said.
Transgene SA of France has appointed Alessandro Riva, the current chairman, as chairman and chief executive officer, and confirmed its commitment to its oncolytic virus portfolio. This follows a decision by AstraZeneca Plc to end a research and development collaboration with the company and hand back an oncolytic virus asset poised to start clinical development in the US. According to Transgene, AstraZeneca took the decision after a strategic review of its pipeline. The French company said the decision would have a “limited impact” on its financial guidance.
argenx SE of the Netherlands continued the expansion of its antibody treatment for autoimmune diseases, Vyvgart (efgartigimod), with regulatory filings for a new formulation of the product in the US, Japan and Europe. Vyvgart is a biologic that was approved by the US Food and Drug Administration in late 2021 and subsequently in the EU and Japan to treat generalised myasthenia gravis (gMG), a chronic autoimmune disease.
MorphoSys AG accelerated the clinical development of its two top cancer drugs in the first quarter whilst also stopping work on preclinical programmes and reducing the size of its workforce. Jean-Paul Kress, the chief executive, told investors on 4 May that the company’s strategic focus is to complete development of pelabresib, a small molecule drug for myelofibrosis, and expand indications for Monjuvi (tafasitamab), an approved antibody which was launched in the US for second-line diffuse large B cell lymphoma (DLBCL) in 2020.
A vaccine developed by GSK Plc to protect older adults against infection from the respiratory syncytial virus (RSV) has been approved in the US and given a positive opinion in the EU – the first such treatment to be approved anywhere in the world. The vaccine, Arexvy, will be launched in the US before the next RSV season which typically starts in the autumn and peaks in the winter. Launch in Europe is expected to follow a formal decision on marketing authorisation, which will be taken by the European Commission.
Eli Lilly and Co reported positive results for its Alzheimer’s disease drug donanemab on 3 May saying that the Phase 3 TRAILBLAZER-ALZ 2 trial met the primary and all secondary endpoints measuring cognitive and functional decline. The company expects to make a regulatory submission to the US Food and Drug Administration by 30 June. Lilly submitted a regulatory application for donanemab to the FDA in January but the agency turned it back citing insufficient data.