SOURCE: Adeona Pharmaceuticals, Inc.

December 15, 2008 08:44 ET

Adeona Pharmaceuticals Expands Patent Estate for Oral TRIMESTA Through an Option Agreement With University of Kansas

Complements Existing Intellectual Property Portfolio for Oral TRIMESTA

ANN ARBOR, MI--(Marketwire - December 15, 2008) - Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty pharmaceutical company developing innovative clinical-stage drug candidates for the treatment of autoimmune and central nervous system diseases, announced today that it has expanded its intellectual property estate through an option agreement to license with the University of Kansas relating to various uses of oral estriol for the treatment of various immunomodulatory diseases. TRIMESTA (oral, once-daily estriol) is being developed in an ongoing double-blind, phase IIb clinical trial for the treatment of relapsing remitting multiple sclerosis.

Dr. B. T. Zhu, Professor of Pharmacology, Toxicology and Therapeutics at the University of Kansas, has demonstrated that estriol has strong immunomodulating effects versus other estrogens through its ability to reduce the risk of developing antibody-mediated immune attacks. These results are detailed in a peer reviewed scientific journal article entitled, "Unique effect of the pregnancy hormone estriol on antigen-induced production of specific antibodies in female BALB/c mice," contained within the March 2008 issue of the scientific journal Steroids, 73(3):289-98.

Dr. Zhu commented, "We are pleased to have entered into this agreement with Adeona. Our research, along with that of Dr. Voskuhl, has clearly differentiated estriol from other estrogens, such as estradiol. We look forward to seeing additional results on the effectiveness of estriol from the ongoing immunomodulating preclinical studies."

James Baxendale, Executive Director of the University of Kansas Center for Technology Commercialization commented, "Collaborating with industrial partners such as Adeona is key to the transfer of our intellectual property into the private sector. We have been impressed with Adeona's collaborative efforts for TRIMESTA and its advanced stages of development."

Nicholas Stergis, Adeona's Chief Executive Officer commented, "This expansion of our intellectual property through collaborative university based relationships complements our existing issued patent estate for TRIMESTA, which has been exclusively licensed from UCLA. Dr. Zhu's work may help to expand the utility of TRIMESTA into other autoimmune diseases."

TRIMESTA is the subject of an ongoing multi-center, double-blind, placebo-controlled 150-patient phase IIb clinical trial for the treatment of relapsing remitting multiple sclerosis (MS) which is being funded by a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH). For further information on this clinical trial, please visit www.clinicaltrial.gov.

About TRIMESTA

TRIMESTA is an orally active, immunomodulatory and anti-inflammatory molecule which has been approved and marketed throughout Europe and Asia for approximately 40 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 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, psoriasis and rheumatoid arthritis) during pregnancy, especially during the third trimester. Adeona has an exclusive worldwide license with UCLA (through the Regents of the University of California, Los Angeles) to the intellectual property rights surrounding TRIMESTA for which Dr. Voskuhl is an inventor.

Pregnancy and MS

Doctors have known for decades that women often experience a sharp drop in MS disease symptoms during the course of pregnancy, specifically in the third trimester when the levels of estriol is being produced at their highest level by the placenta. The list of autoimmune diseases that improve during pregnancy includes multiple sclerosis, rheumatoid arthritis, thyroiditis, uveitis, juvenile rheumatoid arthirits, ankylosing spondylitis with peripheral arthritis and psoriatic arthritis.

A landmark clinical study published in the New England Journal of Medicine, known as the PRIMS study (Pregnancy in Multiple Sclerosis) followed 254 women with MS during 269 pregnancies and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy from pre-baseline levels and relapse rates then increased by 120 percent (p < 0.001) during the first three months postpartum before returning to pre-pregnancy rates (3).

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 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 billion.

About Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of autoimmune and central nervous diseases. Adeona's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and to complete the further clinical testing, manufacturing and regulatory requirements and seek marketing authorizations. Adeona is focused on treatments for rheumatoid arthritis, multiple sclerosis, dry age related macular degeneration (AMD), and fibromyalgia. For further information, please visit, www.adeonapharma.com.

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Adeona's commercialization plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of Adeona's product candidates to be demonstrably safe and effective, a failure of the TRIMESTA clinical trial to provide favorable results, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, Adeona's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Adeona's report on Form 10-Q for the quarter ended September 30, 2008. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact Information

  • For Further Information, Contact:

    Nicholas Stergis
    Chief Executive Officer
    (734) 332-7800

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