Tikvah Therapeutics Licenses Unique Solution Formulations Useful in
the Treatment of Neurodegenerative Diseases, Including Spinal
Muscular Atrophy, From Navinta, LLC
ATLANTA, Aug. 7, 2007 (PRIME NEWSWIRE) -- Tikvah Therapeutics, Inc.
(Tikvah), a biopharmaceutical company focused on new treatment
options to better manage central nervous system diseases, and Ewing,
N.J.-based Navinta, LLC (Navinta) announced today that Tikvah has
entered into an exclusive worldwide licensing agreement that
encompasses unique solution formulations, including a proprietary
formulation of sodium phenylbutyrate, and methods of use and
treatments of a variety of neurodegenerative disorders including,
amongst others, spinal muscular atrophy, amyotrophic lateral
sclerosis and multiple sclerosis, and certain metabolic disorders.
Navinta's proprietary formulation of sodium phenylbutyrate overcomes
the unpleasant taste, unpleasant smell, and lack of solubility of
existing oral products being explored for the treatment of various
neurodegenerative diseases. Clinical studies have often been hampered
by lack of availability of formulations optimized for use in infants,
children, and older individuals with difficulties in swallowing. In
addition, current clinical trials in children with spinal muscular
atrophy (SMA) have experienced high rates of drop outs due to the
unpleasant taste, smell, and large bulk of poorly soluble
preparations of drug products that are often administered as
ground-up tablets or powders. The Navinta technology provides a
platform for preparation of non-viscous, concentrated solution
formulations of drugs that incorporate various taste masking and
smell masking components.
"We believe that these formulations developed by the scientists at
Navinta, represents a significant advance for the treatments of SMA
and certain neurodegenerative diseases," said Dr. Harold H. Shlevin,
President and Chief Executive Officer of Tikvah Therapeutics. "This
technology has the potential to enhance patient compliance and to
facilitate the treatment of infants, children, and older patients who
suffer from neurodegenerative diseases and who have difficulties
swallowing. We are also optimistic that the taste and smell masking
properties coupled to the non-viscous concentrated solution
formulation should overcome the objections, difficulty in accurately
dosing, and patient refusal experienced with many current drug
products being studied."
Under the terms of the agreement, Tikvah will pay a licensing fee,
potential milestones, and royalty payments in exchange for an
exclusive worldwide license to pursue the commercial development of
the technology for the treatment of SMA and other neurodegenerative
diseases.
"We are pleased to entrust the development and commercialization of
our innovative formulation product to an organization with a sincere
dedication to treatment of children and others who struggle with
neurodegenerative diseases," said Dr. Mahendra Patel, Chief Executive
Officer of Navinta, LLC. "Our work represents the culmination of many
years of laboratory and drug delivery technology development work."
Bringing Hope to Life....(sm)
About Spinal Muscular Atrophy
Spinal muscular atrophy (SMA) is a genetic, motor neuron disease
characterized by wasting of the skeletal muscles caused by
progressive degeneration of the anterior horn cells of the spinal
cord. The disease causes weakness and atrophy of the voluntary
muscles more commonly in the legs than in the arms. Patients with SMA
either do not acquire, or progressively lose, the ability to walk,
stand, sit and, eventually, move. Cognition and intellect, emotional
development, and sensory nerves are unaffected. SMA is one of the
most prevalent genetic disorders. It can strike anyone of any age,
race or gender. One in every 40 people carries the gene that causes
SMA. The child of two carriers has a 25 percent chance of developing
SMA. There are four types of SMA generally recognized. They vary in
severity of symptoms; however, they are rare occurring in one in
8,000 to 10,000 births in the United States. Further information on
SMA is available at www.fsma.org, www.smafoundation.org,
www.fightsma.org, www.projectcuresma.org, amongst others.
About Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), often referred to as "Lou
Gehrig's disease," is a progressive neurodegenerative disease that
affects nerve cells in the brain and the spinal cord. Motor neurons
reach from the brain to the spinal cord and from the spinal cord to
the muscles throughout the body. The progressive degeneration of the
motor neurons in ALS patients eventually leads to their death. When
the motor neurons die, the ability of the brain to initiate and
control muscle movement is lost. With voluntary muscle action
progressively affected, patients in the later stages of the disease
may become totally paralyzed. It is estimated that ALS is responsible
for nearly two deaths per 100,000 population annually. More people
die every year of ALS than of Huntington's disease or multiple
sclerosis and it occurs two-thirds as frequently as multiple
sclerosis. At any one time, approximately 30,000 Americans may have
ALS. For further information on ALS, please see www.alsa.org.
About Tikvah Therapeutics
Atlanta-based Tikvah Therapeutics, Inc. focuses on exploring new uses
for late-stage pharmaceutical compounds in selected therapeutic
indications of central nervous system diseases, including neurology
and psychiatry disorders. Its focus is on new therapeutic uses that
have been confirmed in multiple, clinical proof-of-concept studies.
This strategy shortens product development timelines and
substantially decreases the risk associated with the research and
development efforts. A second prong of its strategy is to focus on
specialized products with multiple stepping-stone indications and
strong patent protections, thus helping to ensure long product life
cycles and manageable commercial risk. Tikvah Therapeutics was
founded by Paramount BioSciences, LLC. For additional information
about Tikvah Therapeutics, please visit www.tikvahtherapeutics.com.
The Tikvah Therapeutics, Inc. logo is available at
http://www.primenewswire.com/newsroom/prs/?pkgid=3966
About Navinta
Navinta, LLC in Ewing, N.J. is a technology driven Pharmaceutical
Company that focuses on novel routes of synthesis of new and existing
drug molecules, novel formulations of liquid dosage form, novel oral
dosage form, novel injectable dosage form and implantable drug
delivery devices. Navinta has currently at least ten patents filed or
approved with the United States Patent and Trademark Office.
About Paramount BioSciences
Paramount BioSciences, LLC is a global drug development and
healthcare investment firm that conceives, nurtures, and supports new
biotechnology companies. For additional information about Paramount
BioSciences, visit www.paramountbio.com.
"TIKVAH THERAPEUTICS, INC.," "Bringing Hope to Life," and the above
logo design are trademarks of Tikvah Therapeutics, Inc., Atlanta,
Georgia USA.
CONTACT: Tikvah Therapeutics, Inc.
Jack W. Callicutt
+1 (404) 920-3190
jcallicutt@tikvahtherapeutics.com
