Pharming Group N.V.
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Publicatie datum
06 okt 2006 - 18:24
Statutaire naam
Pharming Group N.V.
Titel
PHARMING RECIEVES ORPHAN PRODUCT GRANT FROM US FDA FOR RHUCIN®
Bericht
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
Datum laatste update: 04 september 2024