AMARILLO, Texas, Oct. 2 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR) announces the company has signed a licensing
agreement with Atrix Laboratories, Inc. (Nasdaq: ATRX) providing the rights to
oral low-dose interferon-alpha for the treatment of Behcet's disease and oral
papillomavirus warts in HIV-positive patients. The U.S. Food and Drug
Administration (FDA) has granted this product orphan drug status for both
indications.
Dr. Joseph M. Cummins, President and CEO of Amarillo Biosciences, Inc.
said, "Data from our human clinical trials and our mechanism of action studies
show that our low-dose oral interferon-alpha is biologically active and well
tolerated. We are excited to partner with Atrix to take oral low-dose
interferon-alpha to the next level in clinical trials. They have the
expertise to make this an excellent near-term revenue generating opportunity."
Under the terms of the agreement, Atrix paid $485,000 for licensing,
orphan drug designations, and clinical supplies. Atrix will fund the research
and development of the product and will perform the work at their facilities
in Fort Collins, Colorado. As part of the agreement, ABI will receive
payments for specific clinical and regulatory milestones and will receive a
royalty based on sale of any product developed.
Oral papillomavirus warts is a painful chronic condition that affects
approximately 5% of HIV-positive individuals in the U.S. Behcet's disease is
an autoimmune disorder that is characterized by mouth ulcers and generally two
additional "hallmark" symptoms. Currently, both of these severe, chronic, and
debilitating conditions are incurable with no existing satisfactory treatment.
Therapy consisting of surgery, freezing or cautery is only partially
effective.
Low-dose orally-administered interferon-alpha is administered as a lozenge
which is allowed to dissolve slowly in the mouth. Oral dosing with
interferon-alpha has a number of advantages over the injectable form; in
addition to substantially fewer side effects, the lozenge is more convenient,
cost effective and does not require refrigerated storage. The low-dose
interferon product was granted orphan drug designation for a treatment of oral
papillomavirus warts in HIV-positive patients in August 2000 and for Behcet's
disease in January 2000. The orphan designation is designed to promote the
development of treatments for rare diseases and provides certain marketing
exclusivity incentives outlined under the Orphan Drug Act.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, founded in 1984, is a pioneer in the research of low
dose orally-administered interferon alpha as a treatment for a variety of
conditions including Sjogren's syndrome, fibromyalgia syndrome, Behcet's
disease, hepatitis B and C, and opportunistic infections in patients who are
HIV positive. Additional information is available on the Amarillo
Biosciences, Inc. web site at http://www.amarbio.com .
Except for the historical information contained herein, the matters
discussed in this news release are forward-looking statements that involve
risks and uncertainties, including uncertainties related to product
development, uncertainties related to the need for regulatory and other
government approvals, dependence on proprietary technology, uncertainty of
market acceptance of oral interferon alpha or the Company's other product
candidates and other risks detailed from time to time in the Company's filings
with the Securities and Exchange Commission. In particular, see "Item 1.
Description of Business" of the Company's Form 10-KSB for the year ended
December 31, 2000.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
Company News On-Call:
http://www.prnewswire.com/comp/118055.html
CONTACT:
Dr. Joseph M. Cummins, President & CEO of
Amarillo Biosciences, Inc., +1-806-376-1741, ext. 13; or Jim
Drewitz, Investor Relations, +1-972-355-6070, for Amarillo
Biosciences, Inc.
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