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Pipex Pharmaceuticals Announces Broadly Issued European Patent Covering Uses of Oral TRIMESTA for the Treatment of Autoimmune Diseases, Including Multiple Sclerosis

Thursday, September 06, 2007

Claims Covering Use of Estrogens Including TRIMESTA, in Combination With Popular Immunotherapies to Treat Multiple Sclerosis

Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has received a broadly issued European patent which covers the use of estrogens in combination with other FDA-approved multiple sclerosis therapies for the treatment of autoimmune diseases.

The issued European patent, EP1286664 entitled, "Combination of Low Dose Estrogen and Immunotherapeutic Agent for Treating Immune Diseases," covers the use of estrogens and their derivatives at serum concentrations above basal and below pregnancy levels in combination with various immunotherapeutic agents, such as, Avonex®, Betaseron®, Copaxone®, Rebif® and Enbrel® for the treatment of Th1-mediated autoimmune diseases, such as, multiple sclerosis (MS), psoriasis and rheumatoid arthritis (RA). The corresponding U.S. and Japanese patents are currently pending.

"This patent issuance supplements our intellectual property estate which already includes U.S. Patent No. 6,936,599 which covers the use of TRIMESTA at pregnancy levels for the treatment of multiple sclerosis. This issued patent is an important addition to our leadership position in estrogen therapy for the treatment of autoimmune disease in women," said Steve H. Kanzer, Pipex's Chairman and CEO.

Through a wholly owned subsidiary, Pipex has obtained exclusive licenses to these patents from the University of California, Los Angeles (UCLA) and Oregon Health & Sciences University (OHSU).


TRIMESTA (oral estriol) is an orally active immunomodulatory and anti-inflammatory molecule that has been approved and marketed throughout Europe and Asia for the treatment of post-menopausal hot flashes for approximately 30 years, but has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and psoriasis) during pregnancy, especially during the third trimester. TRIMESTA has completed a 22-month crossover Phase II clinical trial for the treatment of MS and has recently entered a Phase II/III clinical trial under a $5 million grant from the National MS Society.

About the Phase II/III Clinical Trial

The clinical study is a double-blind, placebo-controlled trial that is currently taking place at seven sites in the U.S., enrolling up to 150 female MS subjects. Investigators are administering TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. TRIMESTA is given in combination with subcutaneously injected Copaxone®, a standard of care treatment for MS. The team is evaluating effects of the treatment combination on relapse rates using several clinical and magnetic resonance imaging measures of disability progression.

The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah and Wayne State University. For further information on this Phase II/III clinical trial, please visit

About Multiple Sclerosis (MS)

MS is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and virtually every hour someone is newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect 2.5 million individuals.

According to the National MS Society, the economic cost of care for MS patients in the United States including medical and non-medical care, production losses, and informal care exceeds $23 billion annually, or more than $57,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities. During 2006, combined sales estimates of FDA-approved injectable MS therapies, which include Avonex®, Betaseron®, Copaxone®, and Rebif®, totaled approximately $5.0 billion.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Relapses often lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and Pipex Therapeutics, Inc. ("we" or "our") current expectations about its future results, performance, prospects and opportunities, including statements regarding any intellectual property protection derived from this patent for TRIMESTA. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA, TRIMESTA, SOLOVAX, Z-Monocys, EFFIRMA or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Avonex®, Betaseron®, Copaxone®, Rebif® and Enbrel® are registered trademarks of Biogen-Idec, Teva, Serono and Wyeth/Amgen.

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