http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20120607:nBw075827a Facility initially to supply EPODURE for U.S. anemia clinical trialsMISGAV, Israel & SAN FRANCISCO--(Business Wire)--Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of the novelBiopump technology for the sustained production and delivery of therapeuticproteins in patients using their own tissue, announced today it has initiatedits first U.S. Biopump processing facility in Davis, California. EPODURE Biopumps for the treatment of anemia are now being processed by theCompany`s contract manufacturing organization ("CMO") in a good manufacturingpractice ("GMP") certified facility. This marks the first Biopump processingsite outside of Israel, and provides Medgenics with a significant ability toscale-up its clinical and commercial capabilities to address global therapeuticareas such as anemia and hemophilia. In a key "dry run" test of the production system, tissue micro-organs wereobtained and loaded into individual closed processing chambers in Israel, andthen shipped to the U.S. CMO Biopump processing center in California. There, themicro-organs were processed in their closed systems into fully functioningEPODURE Biopumps, meeting the release criteria for use in human clinical trialsin the U.S. This demonstrates Medgenics` capability to support the treatment ofpatients at remote clinical sites, transporting their Biopumps to and fromstrategically located processing facilities, thereby allowing for multicenterclinical trials and practical commercial implementation. Medgenics recently announced that it had received clearance from the U.S. Foodand Drug Administration ("FDA") for its Investigational New Drug ("IND")application to conduct a Phase IIb study of EPODURE for the treatment of anemiain dialysis patients in the U.S. "The launch of this U.S. processing facility is another important step foradvancing our U.S. clinical trials and product commercialization. The initialprocessing of Biopumps in the GMP facility of our U.S. CMO resulted in productthat meets all quality requirements for use in human clinical trials. We plan tocontinue with processing additional lots of product to ensure consistency andreliability before the U.S. clinical trial commences," stated Andrew L.Pearlman, Ph.D., President and Chief Executive Officer of Medgenics."Importantly, this U.S. GMP processing center has been launched through anexisting facility, which is much less capital intensive and simpler to establishthan typical protein production facilities. As Medgenics grows and expands, webelieve that similar Biopump processing facilities can be easily set up in othersites around the world." About MedgenicsMedgenics is developing and commercializing Biopump, a proprietary tissue-basedplatform technology for the sustained production and delivery of therapeuticproteins using the patient's own dermal skin biopsy for the treatment of a rangeof chronic diseases including anemia, hepatitis and hemophilia, among others.Medgenics believes this approach has multiple benefits compared with currenttreatments, which include regular and costly injections of therapeutic proteins.Medgenics has three long-acting protein therapy products in development based onthis technology: * EPODURE to produce and deliver erythropoietin for many months from a singleadministration, has demonstrated elevation and stabilization of hemoglobinlevels in anemic patients for six to more than 36 months in a Phase I/IIdose-ranging trial, and has received approval of a Phase IIa trial in dialysispatients due to launch in Q2 2012 in Israel. An Investigational New Drugapplication has been cleared by the FDA to initiate a Phase IIb study toevaluate the safety and efficacy of EPODURE in the treatment of anemia indialysis patients in the U.S. * INFRADURE for sustained production and delivery of interferon-alpha for use inthe treatment of hepatitis is awaiting final approval of two Phase I/II trialsin Israel in hepatitis C, slated to commence in Q3 2012, and is filed for OrphanDrug Designation with the FDA to treat hepatitis D. * HEMODURE for sustained production and delivery of clotting Factor VIII therapyfor the sustained prophylactic treatment of hemophilia is now in development. Medgenics is focused on the development and manufacturing of its innovativeBiopumps, aiming to bring them to market via strategic partnerships with majorpharmaceutical and/or medical device companies. In addition to treatments for anemia, hepatitis and hemophilia, Medgenics plansto develop and/or out-license a pipeline of future Biopump products targetingthe large and rapidly growing global protein therapy market, which is forecastto reach $132 billion in 2013. Other potential applications for Biopumps includemultiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity anddiabetes. Forward-looking StatementsThis release contains forward-looking statements within the meaning of Section27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of1934 and as that term is defined in the Private Securities Litigation Reform Actof 1995, which include all statements other than statements of historical fact,including (without limitation) those regarding the Company's financial position,its development and business strategy, its product candidates and the plans andobjectives of management for future operations. The Company intends that suchforward-looking statements be subject to the safe harbors created by such laws.Forward-looking statements are sometimes identified by their use of the termsand phrases such as "estimate," "project," "intend," "forecast," "anticipate,""plan," "planning, "expect," "believe," "will," "will likely," "should,""could," "would," "may" or the negative of such terms and other comparableterminology. All such forward-looking statements are based on currentexpectations and are subject to risks and uncertainties. Should any of theserisks or uncertainties materialize, or should any of the Company's assumptionsprove incorrect, actual results may differ materially from those included withinthese forward-looking statements. Accordingly, no undue reliance should beplaced on these forward-looking statements, which speak only as of the datemade. The Company expressly disclaims any obligation or undertaking todisseminate any updates or revisions to any forward-looking statements containedherein to reflect any change in the Company's expectations with regard theretoor any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, the events described in theforward-looking statements contained in this release may not occur. Medgenics, Inc.Dr. Andrew L. Pearlman, +972 4 902 8900andrew.pearlman@medgenics.comorLHAAnne Marie Fields, 212-838-3777afields@lhai.com@LHA_IR_PRorAbchurch CommunicationsAdam Michael/Joanne Shears/Jamie Hooper+44 207 398 7719jamie.hooper@abchurch-group.comorNomura Code Securities (NOMAD)Jonathan Senior/Giles Balleny+44 207 776 1200orSVS Securities plc (Joint Broker)Alex Mattey/Ian Callaway+44 207 638 5600 Copyright Business Wire 2012
Medgenics Initiates U.S. Biopump Processing Site MDGN.A MEDGL.L
June 7, 2012




















