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AstraZeneca fails endpoint

08.04.2013 - AstraZeneca's arthritis pill fostamatinib is proven inferior to competitor drugs in a late-stage clinical trial.

While the first-in-class oral rheumatoid (RA) arthritis drug proved to be efficient as measured by ACR20 reponse it failed to halt the progression of joint damage as compared with placebo in the OSKIRA-1 Phase III study. In December, fastamatinib was shown to be inferior in efficacy compared to Abbvie’s injectible RA blockbuster antibody Humira (adalimumab),reducing its ability to compete in the US$20bn-plus RA market. AstraZeneca’ RA pill also increased blood pressure and led to diarrhea.

"Our misgiving is that fostamatinib appears to be inferior to Humira on efficacy and now the adverse events seem to pitch it below Pfizer's Xeljanz, (– another RA pill in late-stage development –) so it is hard to see where the product will fit," said Panmure Gordon analyst Savvas Neophytou.

AstraZeneca, which currently announced the restructuring of its R&D, licensed fostamatinib in 2010 from Rigel Pharmaceuticals. However, after the current study results, analysts forecasted only low fostamatinib sales, averaging just US$171m in 2016. Humira, by contrast, has annual worldwide sales of more than $9 billion but has become under pressure by new RA drugs such as Roche’s RoActemra.

With last year's loss of exclusivity on schizophrenia drug Seroquel, and Nexium for stomach acid and cholesterol fighter Crestor set for U.S. patent expiries in 2014 and 2016, AstraZeneca faces one of the industry's steepest "cliffs" of patent expiries.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/astrazeneca-fails-endpoint.html

FinancingSwitzerlandEU

29.04.2016 Swiss bank Group UBS has raised US$471m (€412m) for the UBS Oncology Impact Fund, which was set up to invest in early-stage cancer treatments. The money raised by the fund, nearly half of which comes from investors in Asia, is the largest amount ever raised for such a cancer investment fund.

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

21.04.2016 For up to US$685m (€606m), Dutch ArgenX has outlicensed its human antibody programme ARGX-115 to AbbVie. The pre-clinical immuno-oncology candidate targets a protein believed to contribute to immunosuppressive effects of T-cells.

RegulatorySwitzerlandEU

20.04.2016 The US government is forking out up to US$100m to get Basilea Pharmaceutica’s broad-spectrum antibiotic ceftobiprole on the US market. In the EU, ceftobiprole is already available.

Immuno-oncologyUK

19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.

FinancingSwitzerlandFranceEUGermanyDenmark

15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.

Event ReviewSwitzerlandBelgiumEU

13.04.2016 Despite political disturbances, 2015 was a good year for the biotech scene in Switzerland. Net sales increased by 5.1% to CHF5,133m and 400 additional people found jobs in the sector. As usual, the new numbers were presented at the annual Swiss Biotech Day – which set new records as well.

FinancingGermanyNetherlandsEU

12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.

Event ReviewGermanyEU

08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.

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