The Sage Group Widens Strategic Role to Assist HemispherX Biopharma in Pandemic Influenza Initiatives as Pacific Rim/Japan Treatment/Prevention Programs Accelerate
Date: 27 May 2009
Clinton, New Jersey, May 27, 2009 -- The Sage Group, a privately held international health care consulting group, announced today that HemispherX Biopharma has expanded the mandate for The Sage Group to include, in addition to the strategic partnering efforts related to Ampligen (an experimental immunotherapeutic) for Chronic Fatigue Syndrome*, additional partnering efforts related to Ampligen’s use to increase the effectiveness of preventative pandemic flu vaccines and the additional role of Alferon LDO (an experimental therapeutic) for treating various types of pandemic flu.
In particular, Sage is assisting HemispherX in its work with the Japanese government in the rapid development of a response strategy for pandemic flu. According to Time Magazine, the number of swine flu cases in Japan are escalating with surprising speed, and health officials are not sure why. The Japanese government on Wednesday, May 20, 2009 confirmed the first two cases of the disease in Tokyo, the world's most populous metropolitan area. Meanwhile, the number of Japanese who have contracted the new flu has more than doubled since May 18 from 130 to 279, a rate of increase that is "without a doubt" the highest in Asia, says Peter Cordingley, regional spokesman for the World Health Organization. "It's explosive."
On Friday morning May 22, 2009, the government was expected to adopt a set of guidelines to fight the flu at the recently established Headquarters for Countermeasures Against Influenza A (H1N1) in Tokyo. The new guidelines will be a modification of an existing plan created to counter the more virulent H5N1 virus, known as avian flu.
Yoshi Mizuta, President of Sage Japan, said “The Japanese government remains concerned about pandemic flu outbreaks and continues to support initiatives such as Dr. Hasegawa’s work (Japanese National Institute of Infectious Diseases) which uses Ampligen along with a vaccine to prevent avian flu as recently reported in the primate studies Dr. Hasegawa has conducted.”
The Sage Group also acted as an adviser to HemispherX in HemispherX’s two recent rounds of PIPE (Private Investment in Public Entities) financings, with Rodman and Renshaw as Underwriter, for approximately $50 million (common shares plus attached warrants). These financings were conducted to generate additional capital to fund the final development and introduction of Ampligen, for Chronic Fatigue Syndrome, in the US market. Wayne Pambianchi, Executive Director of The Sage Group, said “HemispherX’s success in closing this important financing in this troubled financial market,is a clear reflection of the perceived importance of their Ampligen technology in a broad range of immunological applications.”
*HemispherX has already announced that it has been notified by the FDA that the FDA may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen(r) (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome.
About The Sage Group, Inc.
Sage is a senior-level health care, international, technology oriented, strategy and transaction advisory firm formed in 1994. The principals of Sage are seven highly experienced healthcare executives, each of whom has substantial strategic, analytical and hands-on operating experience, as well as extensive backgrounds in licensing – in and out, corporate partnering and M&A. In addition, Sage's advisors and senior directors have extensive knowledge in the clinical, regulatory and product development disciplines. Sage’s principals have played key leadership roles as founders/CEOs in a number of emerging biomedical companies and senior executives in multinational corporations. They have also played key consulting roles in corporate partnering/acquisition and licensing strategies of emerging and mid-sized companies. Sage has offices in the United States, European Union, and Far East. 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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen® and Oragens. Ampligen® 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 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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®, Alferon LDO and Oragens) 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® 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® does not imply that the product will ever be approved commercially.