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

FundingEU

17.04.2014 The European Parliament has given green light to the second Innovative Medicines Initiative with the aim to advance pharmacological research and development, particularly in areas of unmet medical need.

BusinessGermanyFrance

15.04.2014 German flavour and scent specialist Symrise has announced its plans to acquire French pet-food ingredients maker Diana Group for €1.3bn.

BioeconomySpain

14.04.2014 Spanish Neol Biosolutions and the Center for Second Generation Biofuels are starting a partnership to scale-up Neol's waste-to-oil technology.

EvidenceUKSwitzerland

11.04.2014 There is no evidence that neuraminidase inhibitors Tamiflu and Relenza prevent complications of influenza or reduce hospital admissions. In addition, it is unclear whether they can stop the spread of influenza in case of outbreaks, says a report by the Cochrane Collaboration.

BusinessSwitzerlandSpain

09.04.2014 Roche is extending its involvement in the area of point-of-care diagnostics by taking over US company Iquum. In the field of epigenetics, the Swiss pharma company has started a cooperation with the Spanish company Oryzon.

Status ReportSwitzerland

08.04.2014 The Swiss Biotech Report 2014 presented in Zurich sees an encouraging upturn in the country's biotech scene. However, the acceptance of the mass immigration initiative poses a significant threat.

NanobiotechnologyItaly

07.04.2014 Scientists from the University of Udine have designed, produced and tested a prototype for a "DNA origami" nanorobot that can potentially deliver biological activators in-vivo.

EpidemicEUFranceGermanyItaly

02.04.2014 As the Ebola epidemic in Guinea worsens, Europe is deploying the specialists of EMLab to provide diagnostics at the focus of the outbreak.

BioeconomyFranceEU

01.04.2014 The European Commission has approved a French state package aid worth €43m for green chemistry project IEED.

MonitoringEU

27.03.2014 In Europe, bacterial resistance to prevalent antimicrobials is common, while multi-resistance remains low, EFSA and ECDC now report.

Events

All Events

Partner-Events

München

BioVaria 2014

Frankfurt am Main

7th DVFA Life Science Conference

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • PHARMING (NL)0.53 EUR12.8%
  • BAVARIAN NORDIC (D)14.56 EUR10.3%
  • NICOX (F)2.44 EUR7.5%

FLOP

  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.3%
  • GENFIT (F)22.42 EUR-8.1%
  • DEINOVE (F)12.96 EUR-5.3%

TOP

  • BIOTECH PHARMACON (N)17.50 NOK59.1%
  • WILEX (D)0.92 EUR53.3%
  • E-THERAPEUTICS (UK)28.00 GBP40.0%

FLOP

  • CYTOS (CH)0.17 CHF-93.8%
  • BIONOR PHARMA (N)2.11 NOK-44.9%
  • PROTHENA PLC (IE)28.07 USD-40.8%

TOP

  • SILENCE THERAPEUTICS (UK)256.00 GBP6221.0%
  • IXICO (UK)71.50 GBP810.8%
  • PHARMING (NL)0.53 EUR783.3%

FLOP

  • CYTOS (CH)0.17 CHF-95.8%
  • EVOCUTIS (UK)0.22 GBP-92.5%
  • AGENNIX (D)0.04 EUR-77.8%

No liability assumed, Date: 19.04.2014