Pharming: Phase 3 trials of rhC1INH to treat hereditary angioedema look positive

By E. Janene Geiss

Philadelphia, Feb. 24 - Pharming Group NV confirmed Friday the positive outlook for its lead product, recombinant human C1 inhibitor (rhC1INH) based on phase 3 clinical trials for the treatment of hereditary angioedema.

Pharming said it has enrolled 150 patients in its randomized, double-blind, placebo-controlled phase 3 trials for hereditary angioedema, according to a company news release.

Under various clinical studies, Pharming said it has administered more than 90 infusions of rhC1INH and more than 25 patients have been infused with rhC1INH multiple times.

Hereditary angioedema patients treated with rhC1INH in clinical studies show rapid time-to-beginning of relief between 15 minutes to two hours and time-to-minimal symptoms typically within 12 hours.

The clinical results of rhC1INH were presented at an international investigators meeting in Paris with participation of more than 25 clinical centers from Europe, United States and Canada.

The company said it has secured the commercial production of rhC1INH through its collaboration with the Akzo Nobel subsidiary Diosynth BV.

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, officials said.

Pharming said it has submitted orphan drug applications for specific new indications beyond hereditary angioedema. The company said it is starting studies with rhC1INH on specific inflammatory and cardiovascular indications.

Pharming said it 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," Francis Pinto, chief executive officer of Pharming, said in the release.

"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," Pinto added.

Hereditary angioedema is a human genetic disorder caused by a shortage of C1 inhibitor activity. About one in 30,000 individuals suffers from the disease and has an average of seven acute attacks per year. The disease is characterized by acute attacks of painful swelling of soft tissues, including regions of the skin, the intestine, the mouth and throat. If the soft tissue of the throat is involved, an attack of angioedema can be fatal.

Pharming is a Leiden, The Netherlands, biotechnology company developing innovative protein products to treat unmet medical needs.

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