Pharming Confirms Positive Outlook For rhC1INH
Leiden, The Netherlands, February 24, 2006. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM) today confirmed the positive outlook for its lead product, recombinant human C1 inhibitor (rhC1INH) in Phase III clinical trials for the treatment of hereditary angioedema (HAE). The clinical results of rhC1INH were presented at an international investigators meeting in Paris with participation of over 25 clinical centers from Europe, US, and Canada.
Pharming has enrolled 150 patients in its randomized double-blind placebo controlled Phase III trials for HAE. Under various clinical studies, Pharming has administered more than 90 infusions of rhC1INH and over 25 patients have been infused with rhC1INH multiple times. HAE patients treated with rhC1INH in clinical studies show rapid time to beginning of relief between fifteen minutes to two hours and time to minimal symptoms typically within twelve hours.
The Company has secured the commercial production of rhC1INH through its collaboration with the Akzo Nobel subsidiary Diosynth B.V. The partnership has successfully produced consistency batches required for commercial production. The availability of commercial supply of rhC1INH has enabled the Company to pursue compassionate use filings for the product in Europe.
Pharming has submitted orphan drug applications with rhC1INH for specific new indications beyond HAE. The Company is initiating studies with rhC1INH on specific inflammatory and cardiovascular indications. Pharming expects to provide further information on these developments in the first half of 2006.
“Pharming is in a strong position to complete licensing agreements for rhC1INH based on these positive results,” said Dr. Francis Pinto, CEO of Pharming. “With upfront cash payments from these agreements and sales from compassionate use of the product, Pharming aims to be profitable by the fourth quarter of 2006 or first quarter of 2007.”
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 have 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 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 functional 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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- Samir Singh
- Pharming Group N.V.
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