License Covers 17 Countries With a Total Population of 365 Million
AMARILLO, Texas, Sept. 14 /PRNewswire-FirstCall/ -- Amarillo Biosciences,
Inc. (OTC Bulletin Board: AMAR) announces the company has signed a licensing
and supply agreement with a leading Turkish pharmaceutical company, NOBEL ILAC
SANAYII VE TICARET A.S., providing the rights to oral low-dose interferon-
alpha for the treatment of Behcet's disease in Turkey and in Azerbaijan,
Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrghyzstan,
Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkmenistan,
Uzbekistan, and Federal Republic of Yugoslavia.
The license agreement covers a territory whose population is approximately
365 million. In Turkey, where the disease is more than 600 times more
prevalent than in the United States, there are from 56,000 to 259,000 people
who are afflicted with the disease, according to a review published in the New
England Journal of Medicine. The U.S. Food and Drug Administration (FDA) has
granted Orphan Drug Designation for this product for the clinical indication
of Behcet's Disease to Amarillo Biosciences. The Orphan Drug Designation is
designed to promote the development of treatments for diseases rare in the
United States and provides certain marketing exclusivity incentives outlined
under the Orphan Drug Act.
"We are excited to partner with NOBEL 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," said Dr. Joseph
M. Cummins, President and CEO of Amarillo Biosciences. "In Turkey alone, the
market could be more than 100 million interferon doses annually, which
represents an enormous potential for Amarillo Biosciences and NOBEL."
Under the terms of the agreement, Amarillo Biosciences and NOBEL will
conduct Behcet's disease studies in Turkey under an Investigating New Drug
(IND) Application submitted by Amarillo Biosciences to the U.S. FDA. U.S. FDA
approval will be sought and this FDA approval will be owned by Amarillo
Biosciences, but will be used by NOBEL to seek regulatory approval in each
country of the Territory.
Behcet's disease is an autoimmune disorder that is characterized by mouth
ulcers and generally two additional "hallmark" symptoms. Currently, this
severe, chronic, and debilitating condition is incurable with no existing
satisfactory treatment. 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 Behcet's disease in January 2000.
About NOBEL ILAC SANAYII VE TICARET A.S.
NOBEL, founded in 1964 in Istanbul, Turkey, is one of Turkey's leading
pharmaceutical companies with over $110 million in sales and 1,100 employees,
including a sales force of over 600 in Turkey. With developing,
manufacturing, marketing, distributing, importing and exporting activities for
a wide range of ethical products, NOBEL operates in 22 countries, throughout
the world. Additional information is found on NOBEL's web site at
http://www.nobel.com.tr .
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in
global partnership with the Hayashibara Group, which also holds 32% of
Amarillo Biosciences shares. The Company's primary focus is extensive and
ongoing R&D into the use of low-dose, orally administered interferon as a
treatment for a variety of conditions, including Sjogren's syndrome, Behcet's
disease, and opportunistic infections in patients who are HIV positive.
Additional information is available on the ABI 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 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,
2003.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
http://www.nobel.com.tr
Company News On-Call:
http://www.prnewswire.com/comp/118055.html
CONTACT:
investor relations, Philippe Niemetz of WPH
Consultants, Ltd., +1-800-477-7570, or +1-212-344-6464, or fax,
+1-212-618-1276, or philippe.niemetz@wphconsultants.com , for
Amarillo Biosciences, Inc.; or Joseph M. Cummins, DVM, PhD of
Amarillo Biosciences, Inc., +1-806-376-1741, ext. 13, or fax,
+1-806-376-9301, or jcummins@amarbio.com
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