Company to Apply for MUMS Grants to Conduct Studies on Approved Listings
AMARILLO, Texas, Sept. 9 /PRNewswire-FirstCall/ -- Amarillo Biosciences,
Inc. (OTC Bulletin Board: AMAR) announced that it has submitted requests to
the FDA's Office of Minor Use and Minor Species Animal Drug Development (MUMS)
for listing as a Designated New Animal Drug for the Company's natural human
interferon alpha as a treatment and/or prevention of a number of animal
diseases, including: 1) Foot-and-Mouth Disease (FMD) in cattle and swine (FMD
may qualify as a "Minor Use" because it has not been present in the USA since
1927), 2) rotavirus in sheep, 3) papilloma or rotavirus in rabbits, 4)
Pacheco's disease, beak and feather disease or feather picking in psittacine
birds (an order of birds including parrots, cockatoos, macaws and parakeets),
5) chronic wasting disease in deer, 6) infectious pancreatic necrosis in
salmon, and 6) oral papillomas in dogs (a minor use in a major species).
Obtaining a listing as a Designated New Animal Drug will qualify the
company's unique interferon as an "Orphan Drug", thereby making it possible
for ABI to qualify for FDA grants and marketing exclusivity under recently
enacted legislation. Assuming that it obtains the grants that it will be
seeking, Amarillo Biosciences intends to fund a number of studies that would
test its natural interferon alpha for the uses that will have been approved by
the FDA's MUMS. Subject to the successful outcome of these studies, Amarillo
Biosciences would be able to commence marketing (as soon as FDA approval is
obtained) the drug in partnership with a number of animal health companies
that are active in these markets.
"MUMS offers Amarillo Biosciences a unique opportunity to obtain funding
for multiple studies, which could in turn lead to new revenue streams," said
Dr. Joseph M. Cummins, President & CEO, Amarillo Biosciences. "Moreover,
under the Act, Amarillo Biosciences would enjoy market exclusivity for up to
seven years, giving the company a wide window of opportunity to establish its
products in these markets."
A critical shortage of approved animal drugs for minor uses and minor
species exists because of traditional constraints that hindered drug
development for animal diseases including: limited sales opportunity, low
profit margins and the high capital investment that was needed to bring a drug
to market.
In order to remedy this situation, on August 2, 2004 President Bush signed
into law legislation that will increase the number of approved animal drugs
for species and ailments for which treatment options have traditionally been
limited. The Minor Use and Minor Species Animal Health Act (MUMS) is intended
to increase the availability of new therapies for animals, including zoo
animals and some pets for which treatments for many ailments do not exist.
Similar to the program created in 1983 by the Human Orphan Drug Act, which
increases the availability of drugs for rare human disorders, the new MUMS law
offers companies like Amarillo Biosciences an incentive to develop drugs for
uncommon diseases of major animal species and diseases in minor species.
The passage of the MUMS bill marked a victory for animals and a coalition
of 43 organizations that lobbied for the bill. The MUMS legislation creates
the Office of Minor Use and Minor Animal Species Drug Development within the
Food and Drug Administration. Its mission is to issue grants, determine
eligibility for listing on the drug index, and serve as a liaison among
government agencies to improve opportunity for drug approvals.
The term "minor species" refers to thousands of animal species except
dogs, cats, horses, swine, cattle, turkeys and chickens. The term "minor use"
means the intended use of a drug in a major species for an indication that
occurs infrequently and only in a small number of animals.
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
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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