Pharming Completes Recombinant Human C1 Inhibitor Dossiers For Compassionate Use And New Indications
Leiden, The Netherlands, December 28, 2005. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM) (PHARM.AS) announced today that it has completed the recombinant human C1 inhibitor (rhC1INH) dossier for compassionate use filings to treat hereditary angioedema (HAE).
Pharming has started the submission of the rhC1INH dossier to regulatory authorities for compassionate use of the product. Compassionate use filings are intended to ensure availability of key products for unmet medical needs. Several countries have specific legislation for compassionate use to make products available in a quick and efficient manner for patients. This approach will provide for a more rapid availability of rhC1INH for HAE patients in markets with limited treatment options.
Furthermore, Pharming has submitted applications for orphan drug designation (ODD) for the use of rhC1INH for other indications. ODD applications are required to obtain orphan drug status for products targeting rare diseases, which are serious, life-threatening and chronically debilitating. The ODD status provides a period of exclusivity to approved products, various financial incentives and a well-defined regulatory path for approval.
Pharming also expects to complete additional commercial agreements in the near future to further the product potential of rhC1INH in a manner to maximize value for all stakeholders.
“Pharming is pleased with the development of rhC1INH for HAE,” said Dr. Francis J. Pinto, CEO of Pharming. “We look forward to working with authorities to provide rhC1INH for HAE patients.”
Background on Pharming Group N.V.
Pharming Group N.V. is developing innovative protein products for unmet needs. The Company’s products include potential treatments for genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - recombinant human C1 inhibitor for hereditary angioedema (Phase III) and recombinant human lactoferrin for use in foods. 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.
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. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
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- Pharming Group N.V.
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