Pharming Group and Sanofi renew strategic manufacturing partnership agreement


The company is extending its existing 11-year partnership with Sanofi for another 5 years

The company will no longer pursue the implementation of its downstream production facility and will save approx. $ 40 million in capital investments

SUFFER, Netherlands, 23 Dec 2021 / PRNewswire / – Pharming Group NV (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) announces that it has renewed its strategic manufacturing partnership with long-term manufacturing partner Sanofi SA. Annual contract with an extension option ensures the continuation of downstream processing in the production of RUCONEST®, a recombinant C1 inhibitor product that is approved for the acute treatment of hereditary angioedema.

Pharming Group NV logo

As a result, and after careful consideration, especially with regard to the recently significantly increased expansion costs, the company decided to have the construction of the new building completed, but no longer pursue the implementation of its own downstream production capacities in the Pivot Park in Oss. Pharming will continue to use the building under construction for alternative purposes.

As a result, the company saves approx. $ 40 million in capital investments.

Pharming’s Chief Executive Officer Sijmen de Vries commented:

“We are very pleased to renew our long-term downstream processing partnership with Sanofi. Over the past 11 years, Sanofi has proven itself to be the right partner for pharming with continuous on-time delivery of the highest quality and we look forward to further cooperation.

We remain excited to be part of Pivot Park’s biopharmaceutical community, albeit with a presence focused initially on quality control activities rather than downstream production.

Thanks to this renewed manufacturing partnership, we can now fully concentrate on our core competencies; developing and commercializing our products; and investing our human and financial capital in pursuing additional short-term growth opportunities through in-licensing or late-stage product acquisitions. ”

About Pharming Group NV

Pharming Group NV is a global, commercial biopharmaceutical company developing innovative protein replacement therapies and precision drugs for the treatment of rare diseases and unmet medical needs.

The flagship of our portfolio is our franchise with recombinant human C1 esterase inhibitors (rhC1INH). C1INH is a naturally occurring protein that downregulates the complement and contact cascades to control inflammation in the affected tissue.

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). We market 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 sales network.

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

We’re also investigating our precision oral drug leniolisib (a phosphoinositide-3-kinase-delta or PI3K-delta inhibitor) for the treatment of activated PI3K-delta syndrome (APDS) in a registry enabling a phase 2/3 study The United States and Europe.

In addition, we have entered into a strategic partnership with Orchard Therapeutics to research, develop, manufacture and commercialize OTL-105, a newly introduced ex vivo gene therapy for autologous hematopoietic stem cells (HSC) for the treatment of HAE.

In addition, we are leveraging our transgenic manufacturing technology to develop next generation protein replacement therapies, particularly for Pompe disease, which is currently in preclinical development.

Forward-Looking Statements

This press release contains forward-looking statements, including regarding the timing and progress of preclinical and clinical trials by Pharming with its product candidates, Pharming’s clinical and commercial prospects, Pharming’s ability to meet the challenges posed by the COVID-19 pandemic to conduct, manage its business, and Pharming’s expectations for anticipated working capital requirements and cash, the statements of which are subject to a number of risks, uncertainties and assumptions including, but not limited to, the size, progress and expansion of the clinical trials of pharming and the impact on the cost of it; as well as clinical, scientific, regulatory and technical developments. Given these risks and uncertainties and other risks and uncertainties described in Pharming’s 2020 Annual Report and Annual Report on Form 20-F for the past year December 31, 2020 With the 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 by them. All forward-looking statements speak only as of the date of this press release and are based on information available to Pharming at the time of this press release.

Insider knowledge

This press release relates to the disclosure of information that is or may qualify as inside information within the meaning of Article 7 (1) of the EU Market Abuse Regulation.

For more public information, contact:

Pharming group, suffering, The Netherlands
Sijmen de Vries, CEO: T: +31 71 524 7400
Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: [email protected]

RTI consulting, London, Great Britain
Victoria Foster Mitchell/Alex Shaw
T: +44 203 727 1000

FTI Consulting, USA
Jim Polson
T: +1 (312) 553-6730

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

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