News

Sobi and Biogen success in Phase III
Enlarge image

BusinessSweden

Sobi and Biogen success in Phase III

27.09.2012 - Swedish Sobi and Biogen Idec have proved safety and efficacy of a haemophila B drug that prevents bleeding three times longer than other clotting factors.

In the B-LONG Phase III study on 126 haemophila B patients, the partners proved safety and efficacy of their long-lasting recombinant Factor IX Fc fusion protein (rFIXFc). According to the companies, 90.4% of bleeding episodes were controlled by a single shot of  the engineered clotting factor and showed only one serious adverse effect possibly related to the product.  Biogen Idec plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in the first half of 2013. Filing in Europe will require completion of the ongoing Kids B-LONG study in children less than 12 years.

The top line results are good news for the Swedish drug maker, which had to restructure last year due to loss in revenues. According to pharmacokinetic (PK) analysis terminal half-life of the fusion protein of Factor IX and the Fc domain of human IgG(1) was 82 hours compared to 34 hours for BeneFIX.“Our companies are pioneering the application of Fc fusion technology to extend the half-life of clotting factors. Fc fusion technology utilises a naturally-occurring recycling pathway that has been successfully employed in other therapeutic areas. This approach holds promise for combining more consistent protection with fewer injections,” said Sobi CEO Geoffrey McDonough.

The B-LONG study had four treatment arms: weekly prophylaxis, individualised interval prophylaxis, episodic treatment and perioperative management (Arms 1, 2, 3 and 4, respectively). 93.5 percent of patients completed the study. Recombinant FIXFc was generally well-tolerated. No inhibitors to rFIXFc were detected and no cases of anaphylaxis were reported in any patients. The overall median annualised bleeding rates (including spontaneous and traumatic bleeds) were 2.95 in the weekly prophylaxis arm, 1.38 in the individualised interval prophylaxis arm, and 17.69 in the episodic treatment arm. In the individualised interval prophylaxis arm, the median dosing interval during the last 6 months on study was 14 days. 

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2012-03/sobi-and-biogen-success-in-phase-iii.html

SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&ASwitzerland

04.05.2015 Swiss crop chemical maker Syngenta AG is in talks with US company Monsanto to discuss a possible merger, insiders say.

BiofuelsEU

30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.

FinancingSwitzerlandUK

29.04.2015 Biopharma start-up CRISPR Therapeutics has raised US$64m to hurry the new CRISPR/Cas9 technology to the clinic.

FinancingBelgium

28.04.2015 After having raised €100m in its stock market debut, MDx company Biocartis has gained 13 percent on its first trading day.

Swiss Biotech DaySwitzerland

16.04.2015 The Swiss biotech industry can look back on 2014 as a good year, but political uncertainties do remain. This was one of the topics discussed during the Swiss Biotech Day in Basel, which attracted more than 400 participants.

FinancingUK

21.04.2015 Ahead of its listing on the London Stock Exchange, Woodford’s Patient Capital Trust has raised a record sum of €1.1bn. The fund met with immense interest by investors.

PoliticsEU

22.04.2015 A legislative proposal by the European Commission is set to renationalise market authorisation of genetically modified crops.

EventEUFrance

16.04.2015 The changing landscape in healthcare was just one of the hotly discussed topics of the 27th Annual EuroMeeting of the international association DIA.

R&DFranceUKSweden

24.04.2015 AstraZeneca has boosted its oncology portfolio by signing a US$1.275bn agreement with Innate Pharma. The companies plan to further the development of Innate’s tumour-targeting antibody.

Events

All Events

Partner-Events

München

BioVaria 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC5.41 EUR4.04%
  • WILEX5.25 EUR3.35%
  • BIOFRONTERA2.34 EUR1.74%

FLOP

  • VITA 345.86 EUR-6.69%
  • FORMYCON26.31 EUR-6.04%
  • MORPHOSYS63.42 EUR-6.02%

TOP

  • 4SC5.41 EUR322.7%
  • WILEX5.25 EUR83.6%
  • PAION2.85 EUR21.3%

FLOP

  • BIOTEST72.00 EUR-25.9%
  • THERAMETRICS0.07 CHF-22.2%
  • MEDIGENE10.16 EUR-17.6%

TOP

  • SANTHERA96.00 CHF2361.5%
  • CYTOS1.27 CHF647.1%
  • WILEX5.25 EUR517.6%

FLOP

  • MOLOGEN4.85 EUR-55.5%
  • THERAMETRICS0.07 CHF-30.0%
  • BIOFRONTERA2.34 EUR-26.6%

No liability assumed, Date: 05.05.2015