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InViva™ 1 For the Treatment of Anxiety Disorders There is a serious need for a safe and effective pharmaceutical treatment for chronic anxiety. The market potential for a patent protected, branded medication for the treatment of chronic anxiety that is substantially superior to existing alternatives with regard to efficacy, safety, reduction of side effects, and long-term use is substantial. According to the National Institute of Mental Health, 28.8% of the adult U.S. population will suffer from an anxiety disorder.2 Moreover, there is growing evidence that chronic stress and anxiety are leading factors that contribute to the development of chronic medical problems, from Alzheimer’s to cardiovascular disorders, which have enormous consequences for the individual, their family, and our health system. Specific anxiolytic medications, including the popular benzodiazepines, while often effective for acute anxiety, are well known for noxious side effects including sedation, memory and other cognitive impairments, hyperexcitability, tolerance, withdrawal symptoms and dependence. Therefore, they are not clinically appropriate or indicated for chronic anxiety or long-term use.3 Moreover, the patents for the most popular of these medications (Zanex, Prozac and Valium) expired years ago, and these drugs are now widely available in generic form. Non-specific, longer-term pharmaceuticals, including anti-depressant medications (e.g., SRRIs) have some clinical benefits for anxiety, but appear 1 Pondera Anxiety Disorder patent (U.S. Patent No. 8,741,319, June 3, 2013) R. C. Kessler, P. A. Berglund, O. Demler, R. Jin, and E. E. Walters, “Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R),” Archives of Psychiatry, Vol. 62, No. 6, 2005, pp. 593-602. 3 A. N. Vgontzas and E. O. Bixler, “Benzodiazepine side effects: role of pharmacokinetics and pharmacodynamics,” Pharmacology, Vol. 51, 1995, pp. 205-223. 2 to be inconsistent and, at times, anxiogenic with other side effects including sexual dysfunction, sleepiness, and weight gain.4 Finally, while psychotherapy, especially cognitive behavioral therapy (CBT), has been shown to reduce anxiety symptoms,5 it is often insufficient to resolve more serious anxiety disorders and requires specialized services not accessible or attractive to many people. Pondera Pharmaceuticals has found the solution to this pressing clinical problem, which plagues millions every day. Our neuroscientists have devoted the past three decades to researching the endogenous opioid system and have discovered a safe and effective method to reduce the emotional and physical distress signals of the brain. Moreover, we have translated this groundbreaking research into a unique pharmaceutical formulation, which combines ultra-low doses of two drugs used extensively in clinical practice for other indications. By combining ultra-low-doses of roflumilast and naltrexone, InViva™ provides a safe and effective long-term treatment for chronic anxiety disorders and related neuropsychiatric conditions. There is a clear clinical need for InViva™ , a safe and effective anxiolytic medication for the relief of suffering for millions of anxiety patients, which targets the underlying neuro-biochemical imbalances responsible for emotional and physical distress. Since InViva™ relieves chronic anxiety and related neuropsychiatric symptoms without the serious side effects experienced with current drugs, this next generation anxiolytic medication could well become the standard of treatment for these conditions. PARTNERSHIP AND LICENSING AGREEMENTS: Pondera Pharmaceuticals is seeking partnership and licensing agreements for our drug development program. Pondera is the sole owner of these patents and has no obligation to, or contracts with, any third parties with regard to these patents. For more information, please contact William E. Crain, President and CEO Pondera Pharmaceuticals, Inc. Pondera Biotechnologies, Inc. www.ponderapharma.com 209 Chadsey Road Pownal ME 04069 (207) 688-4494 [email protected] E. Cascade, A. H. Kalali and S. H. Kennedy, “Real-world data on SSRI antidepressant side effects,” Psychiatry (Edgmont), Vol. 6, Vol. 2, 2009, pp. 16-18. 5 R. E. Stewart and D. L. Chambless, “Behavioral therapy for adult anxiety disorders in clinical practice: a meta-analysis of effectiveness studies,” Journal of Consulting and Clinical Psychology, Vol. 77, No. 4, 2009, pp. 595-606. 4