News

Pharming: US approval in sight
Enlarge image

RegulatoryNetherlandsSwedenUK

Pharming: US approval in sight

09.11.2012 - Dutch Pharming and its US-partner Santaris Inc. have reported positive Phase III results for Ruconest, their treatment of hereditary angioedema.

The development of Pharming's C1 inhibitor Rhucin, also called Ruconest outside Europe, seemed to be a never ending story. But after the Dutch company and its US-partner Santaris Inc. reported positive top-line data for the protein to treat hereditary angioedema, the story could come to a happy ending. 

Rhucin met the primary endpoint of reducing median time to beginning of symptom relief vs. placebo in the Phase III Study 1310 trial to treat acute attacks of hereditary angioedema (HAE). The positive data trigger a US$10m milestone payment to Pharming from Santarus, which has exclusive commercialisation rights to Rhucin in North America. "We are very pleased with these pivotal study results and look forward to working with our colleagues at Santarus to prepare and submit the Biologics License Application (BLA) for Ruconest to the FDA in the first half of 2013," said Bruno Giannetti, COO of Pharming.  "We anticipate that additional data from this Phase III study will be presented at an appropriate medical meeting in 2013." Last year, FDA refused a similar application. Pharming subsequently amended the protocol to address issues raised by FDA. The recombinant human complement 1 (C1) esterase inhibitor is approved as Rhucin in the EU to treat acute attacks of HAE and is co-marketed with Swedish Orphan Biovitrum (SOBI). Originally, Pharming had begun the first Phase III for Rhucin in April 2004.

Rhucin has exactly the same amino acid sequence as endogenous human C1 inhibitor protein. It is the second recombinant protein produced in transgenic animals to get to market in Europe, following the approval of ATryn, a recombinant antithrombin, extracted from transgenic goat milk, in 2006. In Europe, there is significant competition in the HAE space. Aside from a C1 inhibitor protein derived from human plasma, the main competition for Rhucin on the continent is Shire’s approved Firazyr, a bradykinin B2 receptor antagonist originally developed by German Jerini AG, which delivered sales of about US$10 million in 2010. Firazyr was the first new treatment for HAE in Europe in 30 years.

© eurobiotechnews.eu/pd

http://www.european-biotechnology-news.com/news/news/2012-04/pharming-us-approval-in-sight.html

M&AIreland

31.03.2015 In its aim to expand its drug portfolio in orphan disease products, Horizon Pharma has acquired US company Hyperion Therapeutics for US$1.1bn in cash. The takeover entitles the UK biopharma to all of Hyperion’s common stock.

BusinessGermany

31.03.2015 Merck Serono has forged a US$941m (€876m) deal with US Intrexon for the development and commercialisation of CAR-T therapies. The new CAR-T projects are set to strengthen their R&D technology portfolio in immuno-oncology.

Stock MarketsFranceEU

27.03.2015 Europe is once more proving that it can be a good bet for biotech companies going public. A newly established EU-wide lobbying initiative could help the IPO boom on its way.

FinancingPoland

24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.

BioeconomyFranceSwedenGermanyNetherlandsFinland

23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.

Stock MarketsFranceSwedenUKNorwayIreland

20.03.2015 There are no signs of inertia creeping into the European biotech industry this spring. A total of eight IPOs are set to go public by the end of the year’s first quarter.

FinancingUKEU

17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.

FinancingFranceDenmarkSwedenGermany

19.03.2015 French venture capital firm Seventure Partners has raised a further €25m for its microbiome-focused Health for Life Capital Fund. It now stands at €100m.

EventsFranceEUSwitzerlandUKGermany

12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.

M&ABelgium

11.03.2015 Belgian cell-based therapeutics developer and CMO MaSTherCell SA has been acquired by US biotech Orgenesis Inc. for €23m.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC1.28 EUR10.34%
  • BASILEA110.70 CHF2.31%
  • BIOTEST98.10 EUR2.29%

FLOP

  • PAION2.36 EUR-6.72%
  • MOLOGEN5.45 EUR-4.22%
  • WILEX3.01 EUR-2.90%

TOP

  • CYTOS1.43 CHF297.2%
  • MEDIGENE12.31 EUR184.3%
  • FORMYCON26.94 EUR66.0%

FLOP

  • MORPHOSYS58.81 EUR-19.6%
  • BASILEA110.70 CHF-7.8%
  • WILEX3.01 EUR-4.4%

TOP

  • SANTHERA93.75 CHF2186.6%
  • FORMYCON26.94 EUR271.6%
  • WILEX3.01 EUR157.3%

FLOP

  • CYTOS1.43 CHF-53.1%
  • MOLOGEN5.45 EUR-52.6%
  • PAION2.36 EUR-35.7%

No liability assumed, Date: 01.04.2015