Enhanced Pharmaceuticals, Inc. Enhancing the Safety and Efficacy of Pharmaceuticals. SAFE HARBOR STATEMENT.
Enhanced Pharmaceuticals, Inc. Enhancing the Safety and Efficacy of Pharmaceuticals
SAFE HARBOR STATEMENT Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with pre-clinical and clinical developments in the biopharmaceutical industry in general and in Enhanced Pharmaceuticals’ compounds under development in particular; the potential failure of Enhanced Pharmaceuticals’ compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Enhanced Pharmaceuticals’ compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Enhanced Pharmaceuticals’ business, structure or projections; the development of competing products; uncertainties related to Enhanced Pharmaceuticals’ dependence on third parties and partners. Enhanced Pharmaceuticals' disclaims any obligation to update these forward-looking statements.
MARKET NEED • Patients – Better drugs - Safety & efficacy • Doctors – Better Control - Safety & efficacy • Pharmaceutical Companies: 1. Maintain market share 2. Need solutions for: new drugs, price & generics 3. Life cycle maintenance: • Patent extensions - In the next 5-8 yrs. will lose $1T+ • Better product - Safety & efficacy
BUSINESS STRATEGY A. SAFER VERSIONS OF EXISTING LARGE MARKET DRUGS – MONITIZE BY CO-VENTURES WITH MAJOR PHARMACEUTICAL COMPANIES B. GENERATE REFORMULATION PATENTS BASED ON MAMMALIAN CELL AND ANIMAL MODEL DATA. MONITIZE BY OUT-LICENSING OR INTERNAL DEVELOPMENT
EP-PATENTS • Drug compositions to prevent desensitization of cellular receptors U.S. Pat. 6,673,558 (2004). • Compositions to enhance the efficacy and safety of bio-pharmaceutical drugs. U.S. Pat. 6,593,094 (2003). • Method for determining drug compositions to prevent desensitization of cellular receptors. U.S. Pat. 5,597,699 (1997).
PATENT AND IP STRATEGY • 3 existing patents: • 1 methodology, 2 composition of matter • New methodology patent applied for July 2008 • Writing new therapeutic category patents • Will file new product patents annually
Asthma Other GPCR Drugs Asthma PotentialTherapeutic Targets30-50% of all drugs target GPCRs Cardiovascular Parkinson’s Congestion Memory
ASTHMA DRUGS - THE PROBLEM WARNING • “Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo).” Note: Recommended use of inhalers is 2x/day. Studies have shown that on arriving at an ER many asthmatics have taken as many as 20 puffs in the preceding hour
LEADING ASTHMA DRUGS - 2006*Salmeterol - b2-adrenergic$7.8B of $14.4B($ Billions)MedAdNews July 2007
THE PROBLEM - TOLERANCE Drug tolerance often occurs with repeated or continuous administration of a drug. A person's response to the drug decreases and they require larger doses to achieve the desiredtherapeutic effects. This produces a loss of efficacy and an increase in serious side effects.
GUINEA-PIG TRACHEA % RELAXATION Treatment with Isoproterenol Desensitized and tested with Isoproterenol alone; Desensitized and treated with our drug combination
OVERVIEW EXAMPLE USING VENTRICULAR HEART PRESSURE
EP ADVANTAGES • Methods to optimize efficacy • Receptor modulators included • Combination products that can be patented
ENHANCED PHARMACEUTICALS, INC. • Production of safer products that have reduced side effects & increased efficacy • A robust pipeline with a potential platform technology
EXPECTED REVENUE STREAMS • Licensing fees for specific patented combination products within 2-4 years • Development contracts with major pharma within 2-4 years • Royalties when products reach market
IMMEDIATE PLANS POST FUNDING • New patent and IND filings • Expand the testing of multiple new drug combinations • Start clinical trials of new products • Approach pharmaceutical companies for new contracts
COMPANY STATUS • Company incorporated August 8, 2005. First SAB meeting September 14, 2006 • 3 Patents Issued. 1 applied for (July 2008). We expect to file new specific combinations yearly • Eminent SAB and advisors • Seeking $4-6MM to bring products for treatment of asthma through Phase I
BOTTOM LINE EP PRODUCTS improvements over other reformulations or delivery systems • SAFER WITH FEWER SIDE EFFECTS • ESTABLISHED MARKETS • EXTENDS PATENT LIFE • LOWER COST, SHORTER TIME TO MARKET AND HIGHER SUCCESS RATE • EASIER FDA APPROVAL
BOARD OF DIRECTORS • Richard Lanzara, President & Founder – Ph.D. (Mt. Sinai School of Medicine/CUNY -pharmacology/ biomedical sciences), Nathan A. Selz Prize for Cardiovascular Research. MPH (University of Michigan – cellular chemistry). • Larry Kunstadt, Chairman - Ph.D. (biology), MBA (finance). SVP - Biomedical Investment Banking, vFinance Investments. Taught “New Venture Management” , MBA program, NYU. Currently teaches MDs at NYU Medical School. Business Advisory Board of Institute for the Study of Aging. Companies grown to $9 billion over 25 years. • Perry Molinoff, MD, BOD -Former Vice-Provost of Research, Univ. Pennsylvania. A.N. Richards Professor of Pharmacology. Studied with 3 Nobel laureates – Julius Axelrod, Bernard Katz and James Watson. Ex-Bristol Myers-Squibb – on team that developed Abilify®.
SCIENTIFIC ADVISORY BOARD • Steve Koslow, Ph.D., Acting CEO. Previous Director of Neuroscience and Behavior, National Institute of Mental Health. Managed $250 MM research budget. Created the Human Brain Project. Also worked for Paul Allen Institute for Brain Research. • Perry Molinoff, M.D., Chairman of SAB. Former Vice-Provost of Research, Univ. Pennsylvania. A.N. Richards Professor of Pharmacology. Studied with 3 Nobel laureates – Julius Axelrod, Bernard Katz and James Watson. Ex-Bristol Myers-Squibb – on team that developed Abilify®. • Leonard Cook, Ph.D. Retired from DuPont Merck Pharmaceutical Company. Winner of the 2006 P.B. Dews Lifetime Achievement Award in Behavioral Pharmacology. Developed Thorazine®, Compazine® and Stelazine® at Hoffman LaRoche. Director level.
SCIENTIFIC ADVISOR BOARD (cont) • David R. Hathaway, M.D. - Formerly Vice President of Cardiovascular Drug Discovery, Bristol-Myers Squibb, research cardiologist. Clinical studies supervisor. • David E. Nichols, Ph.D. - Professor of Medicinal Chemistry and Molecular Pharmacology at Purdue University School of Medicine. Medicinal chemist. • William P. Clarke, Ph.D. - Associate Professor, Department of Pharmacology, University of Texas Health Science Center at San Antonio. Receptor expert.
vFINANCE INVESTMENTS, INC. • Registered Broker/Dealer and Investment Bank • Member FASRA/SIPC • 10,000 clients • $1.3 billion under management • 300 employees • 25 bankers – Biomed, IT, finance, real estate • 30 offices • Leading website: 3 million hits per year • Market maker in 2500 stocks