Pharming Receives Fast Track Designation From US FDA For Recombinant Human C1 Inhibitor
Leiden, The Netherlands, July 28, 2006. Biotech company Pharming Group NV (“Pharming”) (Euronext: PHARM) (PHARM.AS) announced today that it has received a Fast Track designation on recombinant human C1 inhibitor (rhC1INH) for the treatment of hereditary angioedema (HAE) from the US Food and Drug Administration (FDA).
The Fast Track designation provides an expedited review process for products used for treatment of serious or life-threatening diseases with limited treatment options and where the product has the potential to have a positive effect on (the symptoms of) the condition. The designation also allows for more frequent interactions with the FDA, which could improve the efficiency of product development and decrease the typical review period.
There is no approved therapy available to HAE patients in the US for the treatment of acute attacks. Clinical studies of rhC1INH have shown that treatment with Pharming’s rhC1INH leads to rapid time to beginning of relief from the attack and reduces time to complete resolution. The rhC1INH product has already been granted Orphan Drug status in this indication which provides a seven year period of market exclusivity in the US upon product approval.
“The Fast Track designation from FDA will help Pharming achieve its goal of delivering rhC1INH to HAE patients as quickly as possible,” said Dr. Francis Pinto, CEO of Pharming. “We look forward to working with FDA to provide a treatment option for HAE patients in the United States.”
Background on Hereditary Angioedema
Hereditary angioedema is a human genetic disorder caused by a shortage of C1 inhibitor activity. Approximately one in 30,000 individuals suffers from HAE and has an average of seven acute attacks per year. HAE attacks that are untreated usually last up to five days. The disease is characterized by acute attacks of painful swelling of soft tissues (edema), including regions of the skin, the intestine, and the mouth and throat. If the soft tissue of the throat is involved, an attack of angioedema can be fatal. In addition to the life-threatening nature of the disease, quality of life for individuals with the disease may be seriously impaired.
Background on Pharming Group NV
Pharming Group NV 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 (MAA submitted to EMEA) and human lactoferrin for use in functional foods (GRAS notification filed with 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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