Hemispherx Biopharma Enters Agreement with Schering Plough

1.12.1999, 11:07

PHILADELPHIA (PROTEXT) - Hemispherx Biopharma, Inc. (Amex:HEB) today announced that it has entered into a multi-year drug-production agreement with Schering-Plough Products L.L.C.,regarding Hemispherx's antiviral product, Ampligen(R). The Ampligen(R) product is currently being clinicallydeveloped by Hemispherx in both the North American and Europeanmarkets for potential treatment of various chronic viraldiseases. The new drug production program will be conducted atSchering's major facilities in San Juan, Puerto Rico, andreplaces small, regionally based facilities that Hemispherx useduntil recently. Under terms of the Agreement, Hemispherx will use the Scheringfacility as its principal manufacturing platform for the U.S.;the Agreement may also be expanded to include other territories.Schering is a world leader with various parenteral (injectable)medications including its flagship antiviral product, interferonalpha (Intron A). William A. Carter, M.D., Chairman and CEO of Hemispherx, said,"This agreement represents a rare example of an exciting synergythat blends our well-recognized research and developmentcapabilities, under the supervision of Dr. Carol Smith, withSchering's world-class experience. Schering's expertise andprofessional capabilities are widely recognized by worldregulatory authorities including the EMEA (European MedicalEvaluation Agency) and the FDA (U.S. Food and DrugAdministration). Indeed, that expertise led to marketing approvalfor more than 20 different diseases for a single drug product,Intron A". Hemispherx said that the new Agreement also offered previouslyunprecedented "economies of scale" and "superior technology" inthe overall drug-manufacturing process. Dr. Carter noted thatproduction of final dosage forms of Ampligen(R) at the Scheringfacilities would be essential to launching a successful overallclinical enterprise by providing accelerated manufacturing of thehighest quality product for its consumers, especially those illwith chronic, debilitating and/or life threatening diseases. Hemispherx already makes available "ready-to-use" Ampligen(R)drug dosage units to certain patients in North America and Europe(through its subsidiary, Hemispherx Europe) under its global"expanded access" programs, while simultaneously conducting PhaseIII clinical research to obtain full-marketing approval. TheCompany said the Schering Agreement was a major new step tofacilitate successful clinical ventures in other major lifethreatening viral diseases, which could eventually expand torequire several metric tons of drug product annually. Dr. Carter added, "When combined with the efficientdistribution and marketing channels being actively developedthrough strategic alliances, our Company's antiviral drugtechnology is now elegantly leveraged for strong growth andpotential profitability. This integrated 'systems management'approach, we believe, may epitomize the successful 21st Centurypharmaceutical development/product launch model. Combiningefficiency, experience, R and D innovation and creative marketingstrategies, we can meet the anticipated needs of all theconstituencies we serve -- namely, physicians, patients andhealth-care insurers." Hemispherx Biopharma, Inc. is a biopharmaceutical companyspecializing in new therapeutic approaches to HIV/AIDS, ChronicFatigue Syndrome (CFS) and hepatitis B/C utilizing the immunesystem. It has offices in Philadelphia, Belgium and France andnew drug development facilities in the Washington, D.C., area.Hemispherx was recently listed on the "Russell 2000" Index ofsmall capitalization stocks. Information contained in this news release other thanhistorical information, should be considered forward-looking andis subject to various risk factors and uncertainties. Forinstance, the strategies and operations of Hemispherx involverisks of competition, changing market conditions, changes in lawsand regulations affecting these industries and numerous otherfactors discussed in this release and in the Company's filingswith the Securities and Exchange Commission. Accordingly, actualresults may differ materially from those in any forward-lookingstatements. ots Original Text Service: Hemispherx Biopharma,Inc. Internet: http://www.newsaktuell.de Contact: William A.Carter, M.D., CEO & Chairman of Hemispherx Biopharma, Inc., 215-988-0080; or William Jenks of Broadgate Consultants, 212-232-2222, or fax, 212-232-3232, for Hemispherx Biopharma; or InvestorRelations, Harris Freedman, 212-572-0762, or fax, 212-572-0764Web site: http://www.broadgate.com Web Site:http://www.hemispherx.com

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