LEIDEN and OSS, The Netherlands, February 8 /PRNewswire-FirstCall/ -- Pharming Group N.V. (Pharming) and Akzo Nobel's biopharmaceutical CMO business, Diosynth Biotechnology announced today a supply agreement for the production of recombinant human C1 inhibitor (rhC1INH) for commercial use.
This agreement enables Pharming to prepare for the market launch of rhC1INH for the treatment of hereditary angioedema, a life threatening genetic disorder caused by a deficiency of the C1 inhibitor protein. Pharming has obtained an Orphan Drug Designation from the FDA and EMEA for rhC1INH in treatment of hereditary as well as acquired form of angioedema.
Under the agreement, Diosynth Biotechnology is responsible for technology transfer, purification-process development, scaling-up and the commercial production of Pharming's rhC1INH at its large-scale downstream processing facility. The facility has been FDA inspected and currently produces commercial products. The financial terms of the agreement have not been disclosed.
"Diosynth Biotechnology is pleased to establish this collaboration on the commercial production of rhC1INH with Pharming," said Jo Lennartz, President of Diosynth Biotechnology. "We look forward to leveraging our broad experience with the downstream production of protein therapeutics to ensure the rapid commercial launch of this important product."
Pharming and Diosynth Biotechnology have been working on technology transfer and scale-up of rhC1INH. These activities have been fully implemented at the Diosynth Biotechnology facility and have resulted in the successful up-scaled GMP production of rhC1INH.
"With Diosynth Biotechnology's extensive manufacturing experience and FDA approved facilities, Pharming is in a strong position to prepare for the market launch of rhC1INH," said Dr. Francis Pinto, CEO of Pharming. "In addition, Diosynth Biotechnology's investment in equipment as well as supplies for rhC1INH production demonstrates a high level of commitment and allows Pharming to move the product forward in a most cost effective way."
Diosynth Biotechnology's large-scale facility is well suited to supply commercial quantities of rhC1INH. The multi-purpose downstream processing facility houses production clean rooms with a broad range of purification and filtration equipment to meet all requirements for commercial production of rhC1INH.
Pharming Group N.V.
Pharming Group N.V. (Euronext: PHARM) (PHAR.AS) is developing innovative protein therapeutics for unmet medical needs. The Company's products include potential treatments for genetic disorders, specialty products for surgical indications, and intermediates for various applications. Pharming's lead product (recombinant human C1 inhibitor) for hereditary angioedema is in Phase III of clinical development. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, as well as technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, http://www.pharming.com/.
Diosynth Biotechnology is Organon's third-party manufacturing services unit for biopharmaceuticals. The company has an 80-year heritage in biologics manufacturing and is a global leader in technology-driven process development and cGMP manufacturing of recombinant proteins, monoclonal antibodies and peptides. We help our customers succeed by developing scalable and robust processes and by driving products efficiently, rapidly and cost-effectively from preclinical development to market supply. Diosynth Biotechnology serves pharmaceutical and biopharmaceutical customers globally and operates FDA-, Health Canada- and EMEA-inspected cGMP manufacturing facilities in Research Triangle Park, NC USA, and Oss, the Netherlands.
Diosynth is part of Akzo Nobel's human healthcare business unit Organon.
The Akzo Nobel Safe Harbor Statement applies to this press release.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
Pharming Group N.V