Regulatory Filings • Jun 7, 2011
Regulatory Filings
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Leiden, The Netherlands, June 7, 2011. Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announced that it has entered into an agreement with MegaPharm Ltd. (MegaPharm), a privately owned Israeli pharmaceutical company, for the commercialization of Ruconest® (recombinant human C1 inhibitor) in Israel for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
Under the agreement, MegaPharm will pay Pharming for completion of certain commercial, regulatory and clinical milestones. MegaPharm will purchase its commercial supply of Ruconest from Pharming at a supply price, based on a percentage of net sales of Ruconest. The number of HAE patients in Israel is estimated at approximately 250. MegaPharm anticipate to launch Ruconest in 2012.
Sijmen de Vries, CEO of Pharming, commented: "We are pleased to have taken a another step towards making Ruconest, an innovative, highly effective and safe replacement therapy, available to HAE patients globally. In MegaPharm we have a strong commercialization partner with a proven track record in this region and strong presence in the immunology therapeutic area."
Miron Drucker, CEO of MegaPharm, said: "We are delighted to have concluded an agreement with Pharming to market Ruconest in Israel. We have been active in the Allergy and Immunology fields for many years and this is an important step in the company's strategy to strengthen our presence and expand our portfolio in this therapeutic area."
Ruconest® is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits. Pharming is developing Rhucin/Ruconest for treatment of patients with acute attacks of Hereditary Angioedema. HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1-inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 – 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest® (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (STO: SOBI). The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, www.pharming.com.
MegaPharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in Israel with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. MegaPharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in select therapeutic areas, and diversified segments of the healthcare business. For more information see www.megapharm.co.il.
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.
Pharming Sijmen de Vries, CEO, T: +31 (0)71 52 47 400
MegaPharm Issy Peimer, V.P. Business Development, T: +972.528.690.616
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