Megapharm voorziet lancering Ruconest KW1 '14
Leiden, The Netherlands, 15 January 2014. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) today announced that its partner, MegaPharm Ltd (MegaPharm), a privately owned Israeli pharmaceutical company, has received marketing approval for RUCONEST® (recombinant human C1 inhibitor) in Israel. The indication as approved is for the treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. Alongside, Ruconest was approved by the reimbursement committee, to be added on the Israel Health basket with no extra costs.
Under the agreement, MegaPharm will purchase its commercial supply of RUCONEST from Pharming at a supply price based on a percentage of net sales. The number of HAE patients in Israel is estimated at approximately 250. MegaPharm anticipate launching RUCONEST during Q1 of this year.
Sijmen de Vries, CEO of Pharming, commented: "MegaPharm is a strong commercialization partner for us and has a proven track record in this region with a strong presence in the immunology therapeutic area. We are looking forward to providing HAE patients in Israel with a new and innovative treatment.”
About RUCONEST and Hereditary Angiodema
RUCONEST (INN conestat alfa) is a recombinant version of the human protein C1 esterase inhibitor, and is produced with Pharming's proprietary transgenic technology. RUCONEST is approved in Europe for the treatment of acute angioedema attacks in patients with HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 esterase inhibitor, resulting in unpredictable and debilitating episodes of intense swelling. The swelling may occur in one or more anatomical areas, including the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. RUCONEST is an investigational drug in the U.S. and has been granted orphan drug designation by the FDA both for the treatment of acute attacks of HAE and for prophylactic treatment of HAE.