Hollis-Eden Pharmaceuticals Announces Notice of Allowable Patent Claims by European Patent Office for Improved Form of HE2000.

Business Editors/Health/Medical Writers

SAN DIEGO--(BUSINESS WIRE)--Oct. 6, 2003

Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH) today announced that it has received notice from the European Patent Office of its intention to grant claims that cover an improved new crystal structure of the investigational drug candidate HE2000 (16 alpha-bromoepiandrosterone hemihydrate). The allowable claims broadly cover the compound, any pharmaceutical formulation that contains the compound, methods to make the compound and methods to use the compound to treat a range of clinical conditions. The allowable medical uses include treatment of viral, bacterial, parasite and fungal infections as well as other clinical conditions including immune suppression, cancer and autoimmune diseases. The claims also include a first medical use claim for 16 alpha-bromoepiandrosterone hemihydrate, which covers its use for the preparation of any pharmaceutical formulation that would contain the compound. The patent will expire in 2020.

The crystal form of HE2000 (IMMUNITIN(TM)) has been utilized in recent clinical trials to prepare formulations for use in treating HIV and malaria infections and will be the basis for all further development activities with HE2000. Hollis-Eden previously reported that it had received notice from the U.S. Patent & Trademark Office of allowable claims covering both the improved structure of HE2000 and pharmaceutical formulations that contain HE2000 as well as methods to prepare the compound. The patent that issues from the U.S. application will expire in 2020. Patent applications containing claims directed to HE2000 and other Immune Regulating Hormones (IRHs) that Hollis-Eden is developing are currently pending or have issued in over 20 countries and regions, including Europe, Japan, Canada, Australia, Africa, China, India and other parts of Asia.

"This notice from the European Patent Office enhances our existing, strong patent portfolio, and further establishes Hollis-Eden as the world leader in the area of Immune Regulating Hormones," stated Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals. "As we continue to conduct the development and clinical work necessary to advance this novel class of compounds into commercial drugs addressing significant market opportunities, we also remain firmly committed to building value for our shareholders by actively extending our intellectual property position. We intend to accomplish that goal both through an ongoing strategy of patent filing and prosecution and, as in the case of our new crystal form of HE2000, through scientific efforts yielding new entities that can be patented."

Hollis-Eden Pharmaceuticals is a development-stage pharmaceutical company based in San Diego, working to become the world leader in the development of a new class of investigational drugs known as Immune Regulating Hormones (IRHs). The goal of IRH therapy is to direct, through controlling gene expression, the production of key cytokines and enzymes that re-regulate immune and metabolic functions toward homeostasis, a profile that could be useful in a wide variety of diseases. The Company has a number of investigational IRHs under development, including HE2100, which the Company is co-developing with the U.S. military for use in protection from radiation injury, and HE2000, which is currently being studied in a number of infectious diseases. Hollis-Eden is also developing an additional IRH, HE2200, for improving vaccine responses in the elderly and for lowering cholesterol in conditions of hypercholesterolemia. For more information on Hollis-Eden, contact the Company's website at http://www.holliseden.com/.

This press release contains forward-looking statements concerning the potential and prospects of the Company's drug discovery program and its drug candidates. Any statement describing a goal, expectation, intention or belief of the Company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including the failure to successfully complete clinical trials, the Company's future capital needs, the Company's ability to obtain additional funding and required regulatory approvals, the ability of the Company to protect its intellectual property rights and to not infringe the intellectually property rights of others, the development of competitive products by other companies and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. The actual results may differ materially from those contained in this press release.