The kinase inhibitor tucatinib has shown a 46% reduction in the risk of breast cancer progression in a Phase 3 trial that enrolled patients who had previously received two antibody treatments and one antibody-drug conjugate. Announcing the results on 21 October, Seattle Genetics Inc said a US regulatory filing is planned for the first quarter of 2020.
A Phase 2 trial of an experimental treatment for atopic dermatitis, MOR106, which was being jointly developed by Galapagos NV, MorphoSys AG and Novartis Pharma AG, has been stopped for futility, the companies announced on 28 October. An interim analysis showed a low probability of the compound meeting it's primary endpoint, defined as the percentage change in the eczema area and severity index score.
Kiadis Pharma NV has strengthened its scientific advisory board to guide the ongoing development of its cell therapy for patients who’ve had a stem cell transplant. This follows guidance from the European Medicines Agency that the product, ATIR101, will not be recommended for approval. ATIR101 has been under regulatory review since 2017.
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%.