Denmark’s Zealand Pharma A/S has expanded its capacity for developing peptide-based medicines with the acquisition of Encycle Therapeutics Inc, a private Canadian company with a preclinical asset for gastrointestinal diseases.
Netherlands-based Pharming Group NV continued its transition into profitability in the first nine months of 2019 with product revenue of €122.8 million, up by 26% from a year earlier, and an operating profit of €42.7 million, up by 38%. This follows the company’s first profit in 2018 on the back of strong sales of its marketed product for acute hereditary angioedemia. The product, Ruconest, is marketed in the US, the EU, South Korea and Israel.
Novartis has teamed up with a UK fund manager and the Cancer Research UK Beatson Institute in Glasgow to develop RAS inhibitors for difficult-to-treat cancers. RAS is a family of genes that make proteins involved in cell signalling pathways that control cell growth and death. It is estimated that more than 30% of all human cancers, including 95% of pancreatic cancers and 45% of colorectal cancers are driven by mutations of the RAS gene family.
Vivoryon Therapeutics AG has raised €43 million from a rights offering and private placement to finance an upcoming Phase 2b study of its lead product for Alzheimer’s disease, PQ912. The product is a small molecule drug that targets an enzyme, glutaminyl cyclase, thought to be responsible for the formation of toxic oligomers in Alzheimer’s disease. The drug has shown promising efficacy signals in an earlier Phase 2a trial – signals that the company hopes to confirm in a larger patient population.
AstraZeneca Plc reported a 16% increase in product sales to $6 billion the third quarter and a rise of 13% in the first nine months to $17.3 billion after years of investment in new products lifted it off one of the industry’s biggest patent cliffs. Driving the result were higher sales of the lung cancer drugs Tagrisso and Imfinzi and strong performances by the antiplatelet medicine Brilinta and the respiratory drug Symbicort. Geographically, sales grew strongly in the emerging markets, led by China, followed by Japan and the US.
Biogen Inc and Eisai Co Ltd have announced plans to seek US regulatory approval for aducanumab, a candidate treatment for early Alzheimer’s disease, just months after two Phase 3 trials for the drug were stopped for futility. The decision to proceed with registration follows discussions with the Food and Drug Administration about a larger dataset from the Phase 3 studies which showed that the drug worked at a high dose.
Led by the plaque psoriasis treatment Cosentyx, sales at Novartis advanced by 10% to $12.2 billion in the third quarter, exceeding analysts’ expectations, and enabling an upward revision in the company’s guidance for the year as a whole. On a constant currency basis, sales were up by 13% for the quarter.
Novartis now expects sales to increase by a high single-digit percentage this year and core operating income, which excludes impairments and amortisations, to grow by more than 10%. Operating income at the quarter was up by 5% to $2.4 billion, giving an operating margin of 19.4%.
A new triple combination therapy for cystic fibrosis, targeting the most common genetic mutation behind the disease, has been approved by the US Food and Drug Administration. Trikafta (elexacaftor/ivacaftor/tezacaftor) is now available to patients 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This is said to represent about 90% of all patients with the disease.
Bavarian Nordic A/S has significantly expanded its portfolio with the acquisition of vaccines for rabies and tick-borne encephalitis from GlaxoSmithKline Plc giving it two licensed products that can be marketed alongside its recently approved vaccine for smallpox and monkeypox infection, Jynneos. The €796 million deal includes an upfront fee of €301 million, plus performance-based milestone payments.
The first vaccine for the active immunisation of individuals at risk of infection from the Ebola virus is being recommended for use in countries affected by the disease including the Democratic Republic of Congo where a public health emergency has been declared by the World Health Organization.
The vaccine, Ervebo, was reviewed by the European Medicines Agency and given a positive opinion on 17 October. It was developed by Merck & Co.