Hemispherx Biopharma, Inc. (AMEX: HEB) has signed a Letter of Intent (LOI) with HollisterStier Laboratories of Spokane, Washington, for the contract manufacturing of Hemispherx’s experimental drug, Ampligen(R). The achievement of the initial objectives described in the LOI, in combination with the Polymer production facility under construction in New Brunswick, N.J., will enable Hemispherx to manufacture the Active Pharmaceutical Ingredient (API) for approximately 10,000 doses of Ampligen(R) per week. Based on the LOI, HollisterStier Contract Manufacturing has agreed to fill the Ampligen(R) API from Hemispherx.
Production for significantly larger quantities of product are planned thereafter. Hemispherx has already commenced the process of transferring manufacturing technology to HollisterStier.
Doug Hulse, Chief Operating Officer and President commented, “We are pleased to be working with HollisterStier, a highly professional group who can support the full commercialization of Ampligen(R) upon FDA approval. We selected this group from a qualified pool of manufacturers and look forward to executing our manufacturing strategy with them.”
Anthony Bonanzino, President and CEO of HollisterStier noted, “The new relationship with Hemispherx Biopharma represents an exciting addition to our well established client portfolio. We are pleased with the Hemispherx decision, and strongly believe the Hemispherx manufacturing strategy is an excellent match to HollisterStier’s core competencies.”
Hemispherx recently completed Phase III testing of Ampligen(R) for Chronic Fatigue Syndrome (CFS).
About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx’s flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis.
Hemispherx’s platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net
HollisterStier Contract Manufacturing provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The company has specialized competencies essential for compounding and filling sterile products. Outsourcing services include vial and syringe filling, as well as commercial and clinical scale capabilities for lyophilization. HollisterStier Laboratories LLC is privately held and located in Spokane, Washington. For more information go to fill.hollisterstier.com.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the company (including Ampligen(R) and Oragens(TM)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.