Regulatory Filings • Jan 15, 2014
Regulatory Filings
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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."
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.
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase 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. RUCONEST® is partnered with Salix Inc. (NASDAQ: SLXP) in North America and a Biologics License Application (BLA) for RUCONEST® is under review by the U.S. Food and Drug Administration. The product is also being evaluated for various follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies. In July 2013, the Platform was partnered with Shanghai Institute for Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre- clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of rhFVIII for the treatment of Haemophilia A. 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 71 524 7400 |
|---|---|
| MegaPharm Issy Peimer, V.P. Business Development, |
T: +972.528.690.616 |
| FTI Consulting Julia Phillips/John Dineen, |
T: +44 (0)207 269 7193 |
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