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

BiosimilarsGermanyFrance

12.09.2014 The 2011 collaboration of Boehringer Ingelheim and Eli Lilly is bearing fruit. An insulin biosimilar developed through the partnership has now been approved in Europe - the first-ever generic version of this class.

FinancingNetherlands

11.09.2014 Cystic fibrosis specialist Proqr Therapeutics has set the terms for its upcoming IPO at US-American stock exchange NASDAQ.

Clinical TrialsUKSweden

09.09.2014 In the midst of the hustle and bustle of the European Respiratory Society’s International Congress 2014, Astrazeneca quietly announced the disappointing results of its latest benralizumab study.

BusinessDenmark

04.09.2014 After their arthritis product’s Phase IIb failure, Novo Nordisk A/S is pulling out of all research and development activities within inflammatory disorders.

BusinessBelgiumIrelandSwitzerland

02.09.2014 In the face of declining revenue, Belgian biopharmaceutical company Thrombogenics has decided to spin out its cancer research and development activities.

ResearchUKSwitzerlandItaly

29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.

BusinessGermany

24.08.2014 Germany's Morphosys is licensing a preclinical bi-specific antibody for the treatment of prostate cancer from Emergent Biosolutions. The US developer will rake in up to €138m for the commercialisation rights to the compound.

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC1.16 EUR0.00%
  • ACTELION110.70 CHF0.00%
  • ADDEX3.32 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC1.16 EUR0.00%
  • ACTELION110.70 CHF0.00%

TOP

  • SANTHERA94.75 CHF47.8%
  • FORMYCON8.30 EUR19.9%
  • EPIGENOMICS3.61 EUR14.6%

FLOP

  • EVOTEC3.12 EUR-16.8%
  • MEDIGENE3.98 EUR-15.7%
  • 4SC1.16 EUR-12.8%

TOP

  • SANTHERA94.75 CHF2524.7%
  • CO.DON2.71 EUR218.8%
  • PAION2.71 EUR155.7%

FLOP

  • CYTOS0.25 CHF-93.7%
  • 4SC1.16 EUR-40.5%
  • MERCK KGAA68.05 EUR-38.7%

No liability assumed, Date: 14.09.2014