Company News

Sales of the glucagon-like peptide 1 (GLP-1) drugs for diabetes lifted Novo Nordisk A/S in the first quarter, more than offsetting the slow growth of the company’s insulins. Group sales amounted to DKK 33.9 billion (€4.54 billion) up by 16% in actual exchange rates and by 14% at constant rates. The operating profit was DKK 16.3 billion, up by 14%, giving an operating margin of 48.1%. The wide margin reflected low administrative costs and relatively low R&D spending. While spending on R&D increased by 41% from a year earlier, as a percentage of sales it was a smaller 11.1%.

Galapagos NV increased its staff by 45% in the year to 31 March in anticipation of the launch of its first pharmaceutical, filgotinib, on global markets. The Belgian company reported an operating loss of €44.6 million in the first quarter, but this was dwarfed by cash and cash equivalents of €5.7 billion, the result of successful equity offerings and a lucrative partnership  with Gilead Sciences Inc for filgotinib, which is in registration for rheumatoid arthritis.

MorphoSys AG achieved a dramatic increase in liquidity in the first quarter following a new licensing deal with Incyte Corp and ongoing milestone payments from its partner Janssen Biotech Inc. Total liquidity amounted to €1.1 billion at the end of the quarter, up from €357.4 million on 31 December 2019. At an analyst briefing on 7 May, Jean-Paul Kress, the chief executive, said the cash will finance the company’s commercial operations in the US ahead of the expected launch of the cancer drug tafasitamab. It will also pay for the in-licensing of new assets.

A new serology test designed to detect protective antibodies in people who have been exposed to the SARS-CoV-2 virus has been given emergency use authorisation by the US Food and Drug Administration, the developer Roche announced on 3 May. The test has also received a CE mark and is eligible for use in Europe. Roche said the test has a specificity of greater than 99.8% and a 100% sensitivity. The sensitivity of a diagnostic test is the proportion of true positives that are correctly identified whereas the specificity is the proportion of true negatives.

A drug originally approved to treat diabetes has now received clearance to also be used for patients with heart failure. The drug, Farxiga (dapagliflozin), is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which works by helping the kidneys lower blood glucose levels. On 6 May, the US Food and Drug Administration authorised Farxiga to treat adults with heart failure with reduced ejection fraction with and without Type 2 diabetes.

The cancer charity Cancer Research UK has chosen a bispecific protein therapeutic as a new development project, electing to take the molecule, CB213, into a Phase I clinical trial in patients with solid tumours. The therapeutic is being developed by Crescendo Biologics Ltd, which announced a partnership with the charity on 5 May. Crescendo has a preclinical portfolio of molecules targeting a range of cancers. The molecules are small, and based on the variable domain of the heavy chain of an antibody.

Norway-based BerGenBio ASA has raised NOK 500 million (€45.4 million) in an oversubscribed private share placement to support the development of its oncology portfolio which focuses on AXL inhibition. The lead candidate, bemcentinib, is in five Phase 2 studies as a single agent, or in combination, in acute myeloid leukaemia and non-small cell lung cancer.

A candidate vaccine against Lyme disease has been given a boost following a collaboration announced on 30 April between the vaccine’s developer Valneva SE and Pfizer Inc. The vaccine, VLA15, is currently in Phase 2 as a prophylactic treatment against Lyme disease. Under the agreement, Valneva will fund 30% of development costs up to regulatory submission. Pfizer will lead late-stage development and be responsible for commercialisation, paying Valneva tiered royalties on product sales starting at 19%.

Bavarian Nordic A/S has received a new order under a 2017 contract with the US government to supply its non-replicating smallpox vaccine to the US strategic national stockpile. The vaccine, Jynneos, is indicated for people who have been determined to be at high risk for infection from smallpox or monkeypox, which both belong to the Orthopoxvirus genus of viruses. It was approved by the Food and Drug Administration in September 2019. According to the Centers for Disease Control and Prevention, the last natural outbreak of smallpox in the US occurred in 1949.

A triple combination therapy for asthma Enerzair Breezhaler, which includes a digital sensor to help patients monitor their treatments, has received a positive opinion from the European Medicines Agency. Assuming formal approval by the European Commission, the drug will be available as a maintenance treatment for asthma in adult patients whose disease is not adequately controlled by a corticosteroid and a long-acting beta2 agonist.