Company News

AZ’s lupus trial fails to meet endpoint

Country
United Kingdom

AstraZeneca Plc has announced that a Phase 3 trial of its proposed antibody treatment for systemic lupus erythematosus (SLE) failed to meet the trial’s primary endpoint of showing a statistically-significant reduction in disease activity as measured at 12 months by a responder index. Called TULIP 1, the trial was a double-blinded, 52-week placebo-controlled study evaluating the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.

Pfizer stops clinical studies in DMD

Country
United States

Pfizer has stopped two clinical studies that were evaluating a proposed antibody treatment for Duchenne muscular dystrophy (DMD) because of lack of efficacy. The first study was a Phase 2 trial testing the treatment for safety and efficacy, while the second was an open-label extension study, the company announced on 30 August.

Semaglutide promotes weight loss in people without diabetes

Country
Denmark

The glucagon-like peptide-1 (GLP-1) analogue semaglutide has demonstrated an ability to promote weight loss in people without diabetes, in some cases up to 13.8%, when combined with diet and exercise. The data comes from a Phase 2 trial comparing semaglutide with liraglutide, another GLP-1 analogue, and with placebo.

Affimed secures deal with Genentech

Country
Germany

Roche’s Genentech has committed funding of $96 million to Affimed NV for rights to the German company’s biologics platform for the production of cancer therapies targeting natural killer (NK) cells in the innate immune system. The platform can generate antibodies directed against NK cells as well as against T cells of the adaptive immune system.

Novartis breast cancer trial meets endpoint

Country
Switzerland

Novartis has reported positive Phase 3 data from a trial investigating a new treatment for breast cancer targeting a protein in the PI3K pathway, a signalling pathway for human cancers. The compound, BYL719 (alpelisib), showed an improvement in progression-free survival.

AZ respiratory drug doesn’t show superiority

Country
United Kingdom

AstraZeneca Plc’s treatment for chronic obstructive pulmonary disease (COPD), Bevespi Aerosphere, has shown non-inferiority but not superiority, on one respiratory measure in a Phase 3b trial in which it was compared with a similar treatment from GlaxoSmithKline Plc.

On a second respiratory measure, it failed to show non-inferiority.

Novo and Evotec to collaborate on diabetes

Country
Germany

Novo Nordisk A/S has entered a research alliance with Evotec AG to discover and develop new small molecule therapies for diabetes and obesity, diseases that affect an estimated one billion people worldwide. Financial terms of the agreement weren’t disclosed.

Novo invests in glucose responsive insulins

Country
United Kingdom

Novo Nordisk A/S has acquired a UK university spin-out with technology for a new generation of insulins that would be released automatically into the bloodstream in response to a rise in blood glucose levels. In principle this would make it easier for people with diabetes to manage their disease and achieve tight control over blood glucose levels.

Chinese valsartan banned from EU

Country
United Kingdom

China-based Zhejiang Tianyu Pharmaceutical Co Ltd has had its regulatory clearance for the supply of the active ingredient valsartan to the European market suspended following an inspection showing the presence of N-nitrosodimethylamine (NDMA), a suspected carcinogen. NDMA is classified as a probable human cardinogen based on the results of laboratory tests.

Private equity company to acquire Abzena

Country
United Kingdom

The private equity group Welsh, Carson, Anderson & Stowe (WCAS) is to acquire Abzena Plc, a service company based in Cambridge UK, that has built up an international business in antibody discovery and chemistry services with subsidiaries in two locations in the US.

The acquisition values Abzena at 16 pence per share or approximately £34.4 million, which is more than double the closing price of the company’s shares on the AIM market in London on 15 August. The price is about 1.5 times the company’s revenue of £22 million in the fiscal year ended 31 March 2018.