Pharming Recieves Orphan Product Grant From US FDA For Rhucin®
Leiden, The Netherlands, October 6, 2006. Biotech company Pharming Group NV (“Pharming”) (Euronext: PHARM) (PHARM.AS) announced today that it has received a grant from the US FDA’s Office of Orphan Products Development (OPD) for the clinical development of recombinant human C1 inhibitor (rhC1INH or Rhucin®) for treatment of attacks of hereditary angioedema (HAE).
The OPD grant program provides funding for clinical development of products for rare diseases with limited or no treatment options. The maximum one-year grant to be received by Pharming for clinical development of Rhucin® amounts to US$ 344,861. Pharming is eligible to receive additional funding for Rhucin® development from the OPD after this period if appropriate.
“Pharming is committed to developing products for unmet medical needs. We appreciate the FDA’s funding for Rhucin® clinical development in the US and the acknowledgement of Rhucin®’s promise as a treatment for HAE,” said Dr. Francis Pinto, CEO of Pharming.
Rhucin® has Orphan Drug designation for the treatment of attacks of HAE. The FDA Orphan Drug designation is reserved for promising new therapies being developed to treat diseases that affect fewer than 200,000 people in the United States. This designation provides an accelerated review process, certain tax advantages, eligibility for grants for clinical studies and a seven-year period of market exclusivity in the US upon product approval.
In the United States, the rhC1INH product is being studied in a randomized, placebo-controlled, double blind clinical trial for the treatment of patients with acute attacks of HAE. There is currently no approved therapy available in the US for the treatment of acute HAE attacks.
Background on Hereditary Angioedema
Hereditary angioedema (HAE) is a human genetic disorder caused by a shortage of C1 inhibitor activity. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which usually last up to five days when untreated. In the Western world, approximately 1 in 30,000 individuals suffers from HAE, having an average of seven acute attacks per year.
Background on Pharming Group NV
Pharming Group NV is developing innovative protein products for the treatment of genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema (under review by EMEA) and human lactoferrin for use in functional foods (GRAS notification under review by US FDA). 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 NV
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