Pharming Group N.V. announces the reimbursement of RUCONEST® in Spain

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Pharming Group N.V.

04 jun, 2021, 05:00 GMT

LEIDEN, The Netherlands, June 4, 2021 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announces that an agreement has been reached with the Spanish Ministry of Health to grant reimbursement for RUCONEST® (conestat alfa) in Spain.

RUCONEST® is the first and only plasma-free recombinant human C1 esterase inhibitor (rhC1INH) protein replacement therapy approved for the treatment of acute hereditary angioedema (HAE) attacks in adults and children aged 2 years and over.1

HAE is a rare genetic condition characterized by recurrent, unpredictable episodic swellings of mucosal or cutaneous sites, causing pain, disfigurement, and disability, which last for hours and, occasionally, several days.2 For affected patients, the disorder is disabling and can sometimes even be fatal if not treated.2

Clinical trial evidence has demonstrated that rhC1INH is efficacious and well-tolerated, and these results have been further confirmed in real-world observational studies.3-7

Mrs Sarah Smith, The President of the Spanish HAE Patient Association (AEDAF), said:

"AEDAF, the Spanish HAE Patient Association, welcomes the approval of new treatments which might help alleviate the suffering of patients with HAE."

Sijmen de Vries, Chief Executive Officer of Pharming, commented:

"We are delighted with this positive reimbursement decision by the Spanish Ministry of Health, as it means patients in Spain in need of new treatment options for hereditary angioedema will now be able to access RUCONEST®. We look forward to working with the Spanish healthcare community to ensure a rapid rollout of the product."

About Pharming Group N.V. 
Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.

The flagship of our portfolio is our recombinant human C1 esterase inhibitor (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation in affected tissues.

Our lead product, RUCONEST®, is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema (HAE) attacks. We are commercializing RUCONEST® in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network.

In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury, and severe pneumonia as a result of COVID-19 infections.

Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development.

Forward-looking Statements 
This press release contains forward-looking statements, including with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, Pharming's ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that that are described in Pharming's 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release.

Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

For further public information, contact:
Pharming Group, Leiden, The Netherlands
Sijmen de Vries, CEO: T: +31 71 524 7400
Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: [email protected] 

FTI Consulting, London, UK
Victoria Foster Mitchell/Alex Shaw 
T: +44 203 727 1000

LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: [email protected]

References

  1. RUCONEST® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8580/smpc#gref  
  2. Longhurst H, et al. Lancet 2012;379(9814):474-481.
  3. Zuraw B, et al. J Allergy Clin Immunol 2010;126(4):821-827.
  4. Moldovan D, et al. Clin Exp Allergy 2012;42(6):929-935.
  5. Riedl M, et al. Ann Allergy Asthma Immunol 2013; 112(2):163-169
  6. Li H, et al. J Allergy Clin Immunol Pract 2015;3(3):417-423.
  7. Valerieva A, et al. World Allergy Organ J 2021;14(4):100535.

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