SOURCE: Pipex Pharmaceuticals, Inc.

January 31, 2008 09:24 ET

Pipex Pharmaceuticals Announces First Notice of Allowance for U.S. Patent Covering Uses of Low Potency Bioidentical Estrogens for the Treatment of Autoimmune Diseases of Women

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

ANN ARBOR, MI--(Marketwire - January 31, 2008) - 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 notice of allowance from the US Patent Office for claims to a patent which covers the use of estrogens in combination with other FDA-approved multiple sclerosis therapies for the treatment of autoimmune diseases.

Pipex's product candidate TRIMESTA (oral, once-daily estriol), which is covered by this notice of allowance, is currently in a Phase III multi-center, placebo-controlled clinical trial in combination with Copaxone for treatment of multiple sclerosis that is being funded by a $5 million grant from the National Multiple Sclerosis Society, its largest single grant ever for a clinical trial.

Once issued, this US Patent No. 10/275,833 entitled "Method of treating immune pathologies with low-dose estrogen" will cover 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 including multiple sclerosis (MS), psoriasis, and rheumatoid arthritis (RA). The corresponding US and Japanese patents are currently pending.

Estriol, the active ingredient of TRIMESTA, a low potency bioidentical estrogen used by millions of women in Europe and Asia for over 30 years has been shown in large case controlled studies conducted in Europe to have a substantially reduced risk of breast cancer compared to the limited FDA-approved estrogens available to American women. On January 9th of this year, in response to a citizen's petition filed by Wyeth, a large pharmaceutical company that markets potent horse derived estrogens, the FDA took action to limit the availability of low potency estrogens as a treatment option available to American women.

"This notice of allowance supplements our intellectual property estate which already includes US Patent No. 6,936,599 covering the use of TRIMESTA (oral, once daily estriol) at pregnancy levels for the treatment of multiple sclerosis as well as our European patent which issued last year. It will be an important addition to our leadership position in the use of bioidentical estrogens for women's health. We hope that the notice of allowance from this important patent estate will be followed by further allowances covering uses of estriol at physiologic levels to treat autoimmune diseases of 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).

About Oral TRIMESTA

TRIMESTA (oral estriol) is an orally active immunomodulatory and anti-inflammatory molecule that has been approved and marketed throughout Europe and Asia for the past 30 years for the treatment of post-menopausal hot flashes, but which has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced by women in the placenta during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy, and it is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases, such as multiple sclerosis and psoriasis, in women during pregnancy, especially during the third trimester. TRIMESTA has completed a 22-month crossover Phase II clinical trial for the treatment of MS and 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 six sites in the US, 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 by using several clinical and magnetic resonance imaging measures of disability progression.

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

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 with the disease. 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 US 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 US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information, please visit www.pipexpharma.com.

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 subsidiaries ("we" or "our") current expectations about its future results, performance, prospects and opportunities, including statements regarding the our intellectual property for TRIMESTA and potential use of COPREXA as well as the resolution of any of the deficiencies raised by the FDA in our New Drug Application (NDA) filing for the treatment of initially presenting neurologic Wilson's disease, including the potential delay in potential approval as well as the cost and expense of conducting any additional testing, development and/or clinical trials required by the FDA, the prospects for any regulatory filings in the treatment of neurologic Wilson's disease, including and/or that the FDA will agree with our analysis of data supporting the safety, clinical efficacy, manufacturing, stability and other regulatory requirements necessary for COPREXA to be approved for use in neurologically presenting Wilson's disease or that even if approved for initial indication, that we will be able to conduct and complete necessary initial and registration clinical trials required to support and receive FDA approval for a Supplemental New Drug Application to market COPREXA for the treatment of other disease indications, such as, idiopathic pulmonary fibrosis, Alzheimer's disease and Huntington's disease, for example. 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, including risks set forth in our filings with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA™, TRIMESTA™, zincmonocysteine, SOLOVAX™, 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, other than as required by law. Avonex®, Betaseron®, Copaxone®, Rebif® and Enbrel® are registered trademarks of Biogen-Idec, Teva, Serono and Wyeth/Amgen.

Contact Information

  • For Further Information, Contact:

    Steve H. Kanzer, CPA, Esq.
    Chairman and Chief Executive Officer
    (734) 332-7800

    Thomas Redington
    Investor Relations
    Redington, Inc.
    (203) 222-7399