SOURCE: Amarillo Biosciences, Inc.

July 12, 2005 09:30 ET

Amarillo Biosciences Low-Dose Oral Interferon Study With NOBEL to Treat Behcet's Disease Clears FDA Review Process

Study Expected to Commence in October 2005

AMARILLO, TX -- (MARKET WIRE) -- July 12, 2005 -- Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR) today announced that it has resolved all clinical and safety issues with the U.S. Food and Drug Administration (FDA) and is ready to initiate a study with a leading Turkish pharmaceutical company, NOBEL ILAC SANAYII VE TICARET A.S. The study is expected to commence in October 2005 and to be completed within a year from that date. ABI's oral low-dose interferon-alpha will be tested as a treatment for Behcet's Disease in 90 Turkish patients. NOBEL has a license to ABI's oral interferon in Azerbaijan, Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrgyzstan, Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkmenistan, Turkey, Uzbekistan, and Federal Republic of Yugoslavia.

In Turkey, the incidence of Behcet's Disease -- as a percentage of the population -- is 600 times more common than in the United States. The availability of a large patient population and worldly renowned clinical experts in Istanbul were leading factors in choosing to conduct the study in Turkey. Behcet's Disease is an autoimmune disorder that is characterized by mouth ulcers and generally two additional "hallmark" symptoms such as recurrent genital ulceration, eye or skin lesions or a positive pathergy (skin) test. 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 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 that are 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. 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.

In addition to its NOBEL study on Behcet's Disease, Amarillo Biosciences is engaged in three other human studies involving low-dose interferon alpha. The company is participating in studies of two myeloproliferative diseases at a major cancer center in Texas and an Idiopathic Pulmonary Fibrosis study at Texas Tech University Health Science Center. Amarillo Biosciences is also working on an Helicobacter pylori study funded by National Institute of Health at The Ohio State University.

Separately, Amarillo Biosciences announced that it has been receiving royalty revenues from sales of human interferon alpha to BioVet, Inc., a Tokyo based animal health company. Manufactured by Amarillo Biosciences' longtime strategic partner Hayashibara Biochemical Laboratories (HBL), this interferon, known as Bimuron, is used to treat rotavirus in cattle. BioVet has been selling the Bimuron to veterinarians in Japan since September 2004 following Japanese regulatory approval that was announced July 16, 2004. Amarillo Biosciences owns the worldwide distribution rights outside of Japan to orally administered HBL interferon and receives a royalty on animal health sales in Japan.

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 $150 million in sales and 1,400 employees, including a sales force of over 700 in Turkey. With developing, manufacturing, marketing, distributing, importing and exporting activities for a wide range of ethical products, NOBEL operates in 22 countries. 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. biopharmaceutical company operating in global partnership with the Hayashibara Group, which also holds 20.6% of Amarillo Biosciences shares and has provided over $16.5 million in loans, grants and equity investments. 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, idiopathic pulmonary fibrosis, Behcet's Disease, and opportunistic infections in patients who are HIV positive. In its 20-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The overwhelming majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. 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, 2004.

Contact Information

  • Investor Relations:
    Philippe Niemetz
    WPH Consultants, Ltd.
    Tel: 800-477-7570
    Tel: 212-344-6464
    Fax: 212-618-1276
    e-mail: Email Contact

    Joseph M. Cummins, DVM, PhD
    Amarillo Biosciences, Inc.
    Tel: 806-376-1741 x 13
    Fax: 806-376-9301
    e-mail: Email Contact