EN
NL
back home
30-11-2022 Intravacc launches phase I clinical trial of Avacc 10®, an intranasal subunit booster vaccine for SARS-CoV-2 23-11-2022 Pharming Group announces presentation of new leniolisib data at 2022 ASH Annual Meeting 11-12-2020 Pharming announces enrolment of first patient in US clinical trial for the treatment of COVID-19 with RUCONEST® 09-12-2020 Sanofi and Kiadis satisfy competition condition related to the tender offer 21-01-2020 Pharming receives EMA approval of new facility for expansion of RUCONEST® production 14-01-2020 Pharming announces the placement of €125 million senior unsecured convertible bonds due 2025 14-01-2020 Pharming announces the launch of an offering of approximately €125 million senior unsecured convertible bonds due 2025 07-01-2020 Polyganics Achieves CE Mark Certification for LIQOSEAL® 25-02-2019 Pharming announces abstract presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and sponsorship of the AAAAI Foundation Michael M. Frank, MD, FAAAI Lectureship 31-10-2017 BioGeneration Ventures Fund III reaches EUR 82 million in final close 23-10-2017 Pharming announces warrant exercises and conversions of its Ordinary Bonds into shares mostly through cashless exercise 18-10-2017 BioGeneration Venture’s portfolio company SurgVision acquired by Bracco Imaging 03-10-2017 Dutch Mellon Medical secures € 6 million for market introduction of major innovation in surgical suture technology: single-handed suturing using the Switch® 02-10-2017 Pharming announces positive data from paediatric clinical trial with RUCONEST® 26-09-2017 Pharming Group N.V. and HAEi International Patient Organization announce partnership with Inceptua Medicines Access for “HAEi Global Access Program” 26-07-2017 Pharming announces publication of RUCONEST® prophylactic data in The Lancet 21-07-2017 Pharming announces completion of its refinancing with a single US$100 million debt facility on improved commercial terms 12-07-2017 Agendia’s MammaPrint® Recommended by ASCO Breast Cancer Guideline in Focused Update Based on Landmark MINDACT Trial Data 06-07-2017 Agendia's MammaPrint® recommended by the 2017 St. Gallen International Breast Cancer Guidelines in significant update 03-04-2017 ENG EUR 12,8 miljoen nieuwe financiering voor biotechonderneming Cristal Therapeutics eng 14-03-2017 BioGeneration Ventures contributes to Cristal Therapeutics EUR 12.8 million Financing Round 13-02-2017 Europese Commissie breidt marketingvergunning RUCONEST® uit met zelfstandige toediening 08-12-2016 Pharming announces completion of acquisition of all North American commercialisation rights for RUCONEST® from Valeant 07-12-2016 Cristal Therapeutics and iTeos Therapeutics announce strategic partnership for the development of immuno-oncology therapeutic candidates using Cristal’s CriPec® nanotech platform 07-12-2016 Polyganics announces Birmingham Hand Centre efficacy study of nerve conduit NEUROLAC® in finger surgery

Pharming receives EMA approval of new facility for expansion of RUCONEST® production

Highlights:

Leiden, The Netherlands, 21 January 2020: Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has received European Medicines Agency (EMA) approval (positive CHMP opinion) for a Type II Variation to support a new production facility for its lead product, RUCONEST®.

With the addition of this new facility, Pharming will significantly increase the production capacity of RUCONEST® as it becomes fully operational over the coming year. Pharming is now also able to release the product that was manufactured at the facility during the approval process for commercialisation in the EU. As previously announced, Pharming had identified a potential risk of short-term pressure on the supply of RUCONEST® for the European market due to increasing demand for the product. With the approval of this new facility, the Company believes the risk to supply is now greatly reduced.

The new facility’s post-approval supplement (PAS) for the distribution of RUCONEST® in the US is still under review by the Food and Drug Administration (FDA). Approval of the new facility for distribution in the US is expected in H1 2020.

Sijmen de Vries, Chief Executive of Pharming, said:

“As we continue to see increasing demand for RUCONEST® in the treatment of hereditary angioedema, we are pleased to announce the approval of our new facility, which will enable us to significantly increase production capacity for supply to patients in the EU. In addition, as a result of our recent re-acquisition of RUCONEST®’s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients.”

Science Park 400 Matrix II Building 1098 XH Amsterdam +31 (0)653816427
lmelens@lifespring.nl

  • - Corporate Communications
  • - Healthcare PR
  • - Financial Communications
  • - Content Marketing
  • - Social Media and Online Communications