Healthcare Industry News: protein therapeutics
News Release - March 25, 2008
Pharming signs distribution agreement for Rhucin(R) in TurkeyEczacibasi Group acquires exclusive licensing and distribution rights
LEIDEN, NETHERLANDS--(Healthcare Sales & Marketing Network)--Mar 25, 2008 -- Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has signed an exclusive licensing and distribution agreement with EIP Eczacibasi Ilaç Pazarlama A.S., (EIP) a leading Turkish pharmaceutical company for the marketing and sales of Rhucin® in Turkey. The agreement covers the use of Rhucin® to treat acute attacks of Hereditary Angioedema (HAE) with a right of first refusal to EIP for other indications.
EIP will be responsible for registration of the product in Turkey and has already taken the first steps in this process. Rhucin® may be eligible for an accelerated review procedure given the high medical need for new therapies in the HAE-patient community as a life threatening disease. Data submitted to the EMEA as well as additional data generated after the EMEA-submission will be used in the registration procedure, although the decision on registration in Turkey will be independent of decisions made in the EU or the USA. Under the terms of the agreement, EIP will purchase the product from Pharming and market, sell and distribute it in Turkey. EIP will also pay a license fee to Pharming for the product.
EIP is part of Eczacibasi Group, a prominent Turkish industrial group with investments in pharmaceuticals, personal care products, consumer products, building products and financial services. The Pharma division focuses on imported pharmaceuticals in niche therapeutic areas and has relationships with several leading biotech and pharma-companies including most recently Amgen, Meda, Astellas, Abbott, Agis, Italchimici and Sanofi Aventis.
The current agreement is part of Pharming's strategy to make Rhucin® available to patients worldwide while, at the same time, building a clinical database supporting registration procedures in the EU and the USA.
About Rhucin® and HAE
Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits. Rhucin® is currently under development for treatment of patients with acute attacks of Hereditary Angioedema (HAE). HAE is a human genetic disorder caused by a shortage of C1 inhibitor activity and results in an overreaction of the immune system. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which may last up to five days when untreated. Earlier in 2007, Pharming announced the positive results of an interim analysis of a European placebo-controlled trial in which Rhucin® was shown to be safe and effective in treating acute attacks of HAE. The Independent Data Monitoring Committee reviewed these results and recommended that the Company discontinue further randomized treatments for both ethical and methodological reasons. Recently, another placebo-controlled trial was completed in North America and topline results are expected to become available soon. In this study, 39 patients with acute attacks of HAE were administered either Rhucin® or placebo. In the open label follow-up phase of the trial, patients with acute attacks of HAE were eligible to receive treatments with the product. The site of attacks treated in HAE patients included laryngeal, facial, abdominal, urogenital and peripheral. While the analysis of the placebo-controlled trial will be finalized soon, the results of the open-label treatments were positive and in line with earlier published data. Pharming intends to pursue a filing for marketing approval with the US-FDA soon after the release of results from the placebo-controlled trial.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® for HAE and human lactoferrin for use in food products. 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, as well as technology in the field of DNA repair (via DNage). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
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.
Source: Pharming Group
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