PHILADELPHIA, Oct. 6, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (Amex:HEB) today announced that it has engaged The Sage Group to assist Hemispherx to identify, select, negotiate, and close a corporate partnership for the commercialization of Hemispherx's Ampligen(r) to treat Chronic Fatigue Syndrome (CFS). The U.S. Food and Drug Administration (FDA) notified Hemispherx that it accepted for review the New Drug Application (NDA) for Ampligen(r) to treat CFS as of July 8, 2008. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, Hemispherx expects that the FDA will complete its review and provide an action letter to the company with respect to the NDA by February 25, 2009. Hemispherx has been approached by potential partners and has engaged The Sage Group to assist Hemispherx in the management of this endeavor to achieve an optimal result for shareholders.
"In view of the FDA's acceptance of our NDA filing for Ampligen(r), we believe the time is right to conduct a thorough partnering program in order to enter into an agreement which expedites and optimizes the commercialization of Ampligen(r) for CFS. Partnering with a firm that has a proven and powerful commercialization capability is extremely important for optimizing the development of our company and the value of Ampligen to our shareholders," said Dr. William A. Carter, Chairman and CEO of Hemispherx. "We are delighted to be working with The Sage Group which has an excellent record of success in bio pharmaceutical partnering. Since The Sage Group has worked closely with Hemispherx for many years, it knows the company and Ampligen(r) very well and thus can quickly accelerate this program."
"The FDA's acceptance of Hemispherx's NDA filing was a very significant achievement for Hemispherx. It is the culmination of decades of work to help characterize the disease of CFS, determine Ampligen(r)'s mechanism of action, conduct the several clinical trials, analyze the data, prepare to scale up manufacturing, and submit an NDA. With all of this completed, the primary objective is to strike the best agreement with the best commercialization partner and The Sage Group is eager and enthusiastic to help do so," said Doug Hulse, Executive Director of The Sage Group.
About The Sage Group
The Sage Group is a leader in providing transactional services to healthcare and life science companies in the pharmaceutical, biotechnology, diagnostics, medical device, life science and analytical instrument fields. Sage has offices in the U.S., Europe and Japan. For more information please visit www.sagehealthcare.com
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(r) and Oragens. Ampligen(r) and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 90 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
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), Alferon LDO(r) and Oragens(r)) 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 N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications; similarly, the completion of the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.