PharmaCom BioVet, Inc. Begins to Review the Process to Potentially Receive Minor Use/Minor Species Drug Approval From FDA
June 11 2009 - 8:31AM
Marketwired
PharmaCom BioVet, Inc. (PINKSHEETS: PHMB) is pleased to announce
that the Company has begun the process to potentially apply and
endeavor to receive a Minor Use/Minor Species (MUMS) drug approval
from the Federal Drug Administration (FDA). Meeting the MUMS
requirement is part of the New Drug Approval Process if the Company
decides to potentially run clinical trials on a histone deacetylase
inhibitor for canines with hemangiosarcoma, which the Corporation
is considering the development of. The histone deacetylase
inhibitor would be directed for dogs suffering from an acute type
of cancer, canine hemangiosarcoma. The Minor Use and Minor Species
Animal Health Act became law in 2004.
Minor uses are based on there being a small number of animals
eligible for treatment with the product in question for the
specific intended use. Small numbers have been determined for each
of the 7 major species (cows, horses, pigs, chickens, turkeys,
dogs, and cats). These have been published in a proposed rule
(http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5385.pdf). To determine
if a use is minor, the standard is that the intended use is for a
"small number of animals." There is a different "small number" for
each of the 7 major species and it reflects the number of animals
affected by the disease over a one-year period.
"We are continuing to review the FDA filing requirements in
order to determine if we may meet the requirements stated by the
MUMS Act. By doing so, we potentially progress closer to being able
to begin the testing of a novel cancer treatment for canines with
Hemangiosarcoma," stated Gary S. Berthold, President of PharmaCom
BioVet, Inc.
About PharmaCom BioVet, Inc.:
PharmaCom BioVet, Inc. is positioning itself to become involved
in the specialized Veterinary oncology development and treatment
industry. PHMB is pursuing the licensing and the development of
proprietary compounds and devices.
Safe Harbor Statement:
The information posted in this release may contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. You can identify these
statements by use of the words "may," "will," "should," "plans,"
"expects," "anticipates," "continue," "estimate," "project,"
"intend," and similar expressions. Forward-looking statements
involve risks and uncertainties that could cause actual results to
differ materially from those projected or anticipated. These risks
and uncertainties include, but are not limited to, general economic
and business conditions, effects of continued geopolitical unrest
and regional conflicts, competition, changes in technology and
methods of marketing, delays in completing various engineering and
manufacturing programs, changes in customer order patterns, changes
in product mix, continued success in technological advances and
delivering technological innovations, shortages in components,
production delays due to performance quality issues with outsourced
components, and various other factors beyond the Company's
control.
Contact: PharmaCom BioVet, Inc. Investor Relations Tel: (407)
389-5900 URL: http://www.PharmaComBioVet.com
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