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.