Confidentiality Statement The attached document is hereby disclosed for the sole purpose of evaluating one s interest in entering into a licensing, collaboration, acquisition, other business agreement, or investing in any other way with Aspir-Tek Inc. business to develop and commercialize the technology and products described herein. Further reproduction or distribution of this document, in whole or in part, is expressly forbidden without the prior written consent of ASPIR-TEK inc. Tel: 919 794 7000 web address: www. www.aquaprin.com www.aspir-tek.com 3
SUPERIOR MEDICINE FOR PAIN
THE COMPANY Aspir-Tek is a pharmaceutical R&D/manufacturing/sales and distribution company. The Company has a superior line of scientifically modified and enhanced, IP-protected aspirin products. These products provide unique and substantial medical benefits using one of the world's most universally important and proven/accepted substances as its base. With benefits that far exceed those of competitive aspirin products and other formulations making claims in these medical areas, Aspir-Tek s offerings will be sold at competitive prices while offering materially superior results. This power point presentation is a summary description of the products, their benefits, and a side by side comparison with existing alternatives.
INTRODUCING AQUAPRINTM THE SAFEST THE FASTEST ACTING THE MOST THERAPEUTICALLY EFFECTIVE THE EASIEST TO INGEST OTC medicine for pain, inflammation, heart health, fever reduction, and Cancer prevention
What Is AQUAPRINTM? Aspirin is the Gold Standard of Pain Relief AQUAPRINTM is an advanced, Safer Derivative of Aspirin Many early clinical studies have proven that AQUAPRIN TM is: The Fastest acting, Strongest, Most effective, Safest, Least irritating, easiest to ingest, healthiest OTC medicine for pain, inflammation, Heart Health, and fever reduction. Granular form, in small foil packets, blister packs, and dispensing tubes, that totally dissolves instantly upon contact with water into a clear, tasty drink. Potassium based, (Potassium acetylsalicylate) (650 mg, 800 mg, and 81 mg dose) solubilized crystal clear, residue free, liquid antacid form of aspirin. 2 or more oz. pleasant tasting Liquid in many flavors
What is AQUAPRINTM Indicated For? A recent published study showed that a daily low dose of aspirin can reduce Cancer by 35 to 40% 1. Normal to severe pain relief 2. Headaches, normal & migraine 3. Cox 1 & 2 inhibitor (Arthritis Sufferers) 4. Anti-pyretic (fever reducer) 5. Anti-coagulant 6. Anti-heart attack & stroke 7. Anti-inflammatory 8. Sour stomach, acid indigestion 9. Cancer prevention
AQUAPRINTM Background AQUAPRINTM, is a superior non-steroidal, anti-inflammatory, pain reliever, anticoagulant, fever reducer, and anti-heart attack and stroke and cancer preventative medication. For general use, aspirin is only available in tablet and powder forms in the USA. In these forms, it is acidic, not soluble in water or the gastric system, has low and slow absorbance into the blood stream, and causes gastric irritation and stomach bleeding. Calcium and sodium based water soluble forms of aspirin, available in other parts of the world have proven to be faster acting, more efficiently absorbed into the blood stream and produce significantly less side effects. The negative aspect of these forms is that they take a few minutes to dissolve, leaves a lot of residue, have a gritty bad taste, high levels of sodium or calcium carbonate and do not meet FDA regulations for sale in the USA. AQUAPRINTM, the only potassium based superior form of a water soluble aspirin is positioned to take aspirin to the highest level of safety, efficacy, speed of relief, and taste, outperforming all other OTC pain medications.
THE CHEMISTRY OF AQUAPRINTM Aspirin does not dissolve in water, is acidic and only about 45% of the aspirin salicylates get absorbed into the blood stream. With AQUAPRINTM, aspirin and potassium bicarbonate are physically bound together into small crystals. When these crystals are introduced into the presence of water, an instant chemical reaction takes place. Using Aspir-Tek s technology, this reaction instantly and totally dissolves the aspirin forming AQUAPRINTM, which is a residue free clear drink, ready to ingest in ~ 25 seconds. AQUAPRINTM is the water solubilized potassium salt of aspirin, (potassium acetylsalicylate). In this form, it is non acidic, is antacid, safest, fastest acting, and an extremely more therapeutically effective derivative of aspirin. The potassium based aspirin derivative also provides about 350 mg of potassium with each dose.
Physical Properties of AQUAPRINTM 2.75.75 ACTUAL SIZE A crystalline form, packaged in a small foil Strip Pack which totally dissolves in less than 30 seconds in 2 oz. or more tap water into a clear, effervescing tasty drink. No undissolved grit or residue. Antacid. Solubility and taste superior to marketed sodium or calcium-based forms of aspirin in Europe. Free-flowing crystalline form packaged in.75"x2.75" foil packets. Available in several pleasant flavors.
DISSOLUTION Properties of AQUAPRINTM COMPLETELY DISSOLVES 650 mg of AQUAPRIN TM ASPIRIN CRYSTALS IN 25 SEC. Note: Blue Raspberry Flavored
AQUAPRIN TM DAILY REGIMEN FOR THE PREVENTION OF HEART ATTACK, STROKE, AND CANCER Packaged in a small foil packet (1 x 1 ), and blister strips, which contains a crystalline formulation. When the ingredients are added to 1 or more ounces of water or any other drink of any quantity, a chemical reaction takes place. This reaction instantly solubilizes the 81 mg of aspirin into a clear tasteless solution without any undissolved particles or scum. The results are a much safer and therapeutically more effective delivery of aspirin.
AQUAPRINTM Children s & Teenagers. Packaged in small foil packets, (1 x 1.5 ), and blister strips, which contains a crystalline formulation. When the ingredients are added to 1 or more ounces of water or any other drink of any quantity, a chemical reaction takes place. This reaction instantly solubilizes the 81 mg of aspirin into a clear tasteless solution without any un-dissolved particles or scum. The results are a much safer and therapeutically more effective delivery of aspirin for children & teenagers.
AQUAPRINTM /INSTA-PRIN DELIVERY SYSTEM DESIGNED FOR EMERGENCY USE A disposable device for one-time emergency use, which contains a crystalline formulation in one sealed compartment and 1.5 oz. of water in an expandable and squeezable container. Upon activation, INSTA-PRIN is instantly solubilized in the water compartment. The solution can then be dispensed in seconds by squeezing the water compartment, delivering 650 mg of solubilized aspirin. INSTA-PRIN is intended for use where water is not always readily available and fast effectiveness is critical. Ideal for first-response treatment of heart attacks and strokes.
The problem with current OTC pain relievers ASPIRIN, (in tablet and powdered form, including Bayer s new Faster Relief Aspirin (NSAID) Aspirin, in tablet, powder, and Bayer s new quick release crystal form forms, is acidic, non-soluble in water, and only about 40 to 45% of the drug ever gets into the blood stream. Because of these forms, it is slow to be effective, taking up to 30 to 40 minutes to reach therapeutic levels and causes side effects such as stomach bleeding and gastric upset. In millions of patients this causes severe gastric distress and sometimes even hemorrhage due to direct contact between un-dissolved aspirin particles and the stomach lining. Indeed, it is precisely these gastro-toxic, ulcerogenic adverse-reactions that prevent many patients from taking full advantage of aspirin s many benefits. ACETAMINOPHEN (TYLENOL) (Non-NSAID) Acetaminophen, the most popular pain reliever has several problems of it s own. It is not an anti-inflammatory drug. It is weak on reducing pain and takes up to 1 hour to reach peak blood levels thereby a slow onset of pain relief. Side effects are liver damage. Recently, acetaminophen products have been found to cause liver damage at lower doses & have been required to black label the product packaging. IBUPROFEN (ADVIL), (MOTRIN), (NSAID) Ibuprofen, like aspirin tablets, has become a very popular pain reliever and basically has the same properties as aspirin. Ibuprofen is not soluble in water and causes gastric bleeding and gastric distress in some patients. The onset of pain relief usually takes at least 25 to 35 minutes. Ibuprofen also carries having a greater risk of heart attack and reduces the effect of an aspirin regimen for reduction of heart attack and stroke. NAPROXEN SODIUM (ALEVE) (NSAID) Naproxen sodium, also known as ALEVE, NUPRIN, and NAPROSYN, has been on the market for many years. It has been sold in the past generally as an anti-inflammatory for long term use. The onset of action is very slow, (at least 30 minutes before relief begins and a few days for inflammation reduction), and the side effects are generally the same as for aspirin and ibuprofen. This product is mainly for long term use of inflammation reduction and arthritis pain release although, can have significant gastric side effects.
The Solution to the problem The scientists at ASPIR-TEK have been developing for a period of over 20 years to effectively, rapidly, and completely convert common aspirin, the GOLD STANDARD of pain relievers, into a much more effective and safer form. What has been achieved is the most significant breakthrough in the pain reliever field in many decades. The potassium based derivative of aspirin, AQUAPRINTM is the safest, most effective, and fastest acting form of aspirin, and as a matter of fact, faster acting and safer, and therapeutically more effective than any other over the counter pain reliever worldwide. Most likely it will be the best OTC pain reliever worldwide. ASPIR-TEK expects to be a leader in the pain management field, and to capture a substantial segment of the analgesic, cardio protective, anti-thrombotic and antipyretic pharmacotherapeutic market because AQUAPRINTM and other line extension products offer significant competitive advantages. AQUAPRINTM is an instantly dissolving, fast-acting, non-acidic, safe, potent, drinkable derivative of aspirin, which virtually eliminates irritation to the GI-tract. It is also a more effective and efficient method of delivering salicylates into the blood stream, achieving almost peak blood plasma levels in 5 to 7 minutes. Moreover, it contains therapeutically active levels of potassium which acts as an antacid, neutralizing stomach acid. Potassium also lowers blood pressure and helps to dilate blood vessels allowing for better blood circulation. Since the aspirin-derivative salicylates in AQUAPRINTM are fully dissolved into an antacid solution, they are immediately absorbed into the blood stream. AQUAPRINTM s antacid characteristics help neutralize stomach acids, thus virtually eliminating local topical and systemic gastric irritation and damage. In addition, salicylates in conventional aspirin tablets are degraded during their passage through the GItract and during metabolism. This causes them to achieve only 30 to 40% absorption efficiency. AQUAPRINTM s unique formula allows it to achieve 100% absorption efficiency.
Aspirin vs. AQUAPRINTM Superiority Of AQUAPRINTM Over Non Soluble Aspirin & Powders Characteristics Aspirin Tablets & Powders AQUAPRINTM Improvement % Absorbed into the Bloodstream 40-45% 100% 110% More Time to Therapeutic Blood Levels 20 Minutes 2 Minutes 10X Faster Time to Peak blood levels 45-60 Minutes 7-10 Minutes 6X Faster % In Blood Stream After 5 Minutes Less than 5% 70-80% 70% More Time to Start Working on Pain 20-30 Minutes 2 Minutes 10X Faster Efficacy of Pain Relief Normal More than Twice More Than 2X Time to Relieve Headaches 25-40 Minutes 5 to 10 Minutes 5X Faster Effectiveness in relieving Migraine Low High- Proven in Studies Much Higher Gastric Irritation 20-25% of Patients 1-2% of Patients 20X Less Gastric Damage Score 2.0.15 90% Less Effect on Gastric Mucosa Acid Antacid (soothing) Safer Dosing Method Two 325 mg Tabs + 6oz of Water 1.5 or more oz. Drink Less Water
Absorption Rate of AQUAPRINTM ABSORPTION RATE of AQUAPRIN Vs. ASPIRIN TABLETS
Solubilized Aspirin AQUAPRINTM Causes Less Gastric Irritation Than Tablets & Powders Mean gastric damage score for 30 volunteers taking a solubilized aspirin vs. solid aspirin tablets at 6,12, and 24 hours. 2.5 Soluble Aspirin Damage Score 2 1.5 1 0.5 Aspirin Tablets This randomized, double blind, crossover study in 30 volunteers involved visual inspection by gastroscopy at various time intervals after drug administration. Data shown drawn from a study by: (Jaiswal et al IUPHAR 9 th International Congress of Pharmacology, 1984) Study done using Disprin brand soluble aspirin. 0 6 Hours 12 Hours 24 Hours Time
Status of Product to Market ASPIR-TEK is currently negotiating the acquisition of a mfg. facility. Design of facilities to meet CGMP now in progress. AQUAPRINTM formulations fully developed and tested, including a sports pain drink. AQUAPRINTM will be available in several flavors, which have already been developed. Packaging and process equipment specifications established and currently being purchased. Processes and formulas have been validated are ready for full scale production. INSTA-PRIN device in final engineering configuration and all basic operating principles tested.
PATENT STATUS The major principle of the company holds over 15 patents in the nuclear and pharmaceutical fields. Three additional patents were awarded in the mid 90 s for a process and formulation of a potassium based soluble aspirin. This product went to market but was not user friendly enough to be successful. However the technology has been significantly improved and perfected for which new patents utilizing a completely different technology have been granted and pending. A new patent covering the formulations and manufacturing processes for Aquaprin has been recently awarded by the U.S. patent office, (Patent # 8,580,853). Additional patent applications have been filed and are in the Patent Pending stage.
AQUAPRINTM Rapid Path to Market No additional FDA approvals required to market Over the counter. AQUAPRINTM conforms to the approved Over the Counter Monographs: USP Official OTC Monograph: Aspirin Effervescent Tablets for Oral Solution. USP Official OTC Monograph: Buffered Aspirin Tablets US Federal Register designation of approved combinations with Aspirin CGMP-compliant manufacturing facility to be registered with the FDA.
Intellectual Property Several major pharmaceutical companies have tried to develop a safer, completely water solubilizing aspirin. To this end, there have been over 50 patents issued for different processes. However, none of these inventions have proven to make a stable, completely solubilized product with an acceptable taste. A few patents for a potassium based solubilized aspirin have been issued. These have proven to be totally unstable, having no shelf life and not totally dissolving. Astra-Zeneca, a major pharmaceutical company has recently engaged a company, agreeing to pay over $300 million dollars to develop a safer aspirin. This will be a prescription product. (years away). ASPIR-TEK, after years of research and development, has succeeded to develop and make stable AQUAPRINTM. One patent has recently been awarded by the U.S. patent office for this technology. However, there is significant know-how that is better not putting into the knowledge of industry and will be kept as company secret.
Sales Potential The pain reliever market in the US alone exceeds $10 billion annually and more than $30 billion worldwide. AQUAPRINTM will compete in the worldwide market for over the counter pain medications having advantages over all other OTC pain relievers. The price point of the AQUAPRINTM product will be very competitive with current OTC branded pain relievers but cost less to produce. COX-2 inhibitors for arthritis generate more than $4 billion annually. AQUAPRINTM is believed to be a safe & effective COX-2 inhibitor for arthritis. With appropriate marketing and endorsements, the sales potential for AQUAPRINTM can exceed $1 billion in the US alone.
Market & Competition The worldwide annual market for soluble forms of aspirin products alone exceeds $2 billion. However, AQUAPRINTM will be positioned to compete in the worldwide over the counter pain reliever sector. The INSTA-PRIN product has no competition worldwide and can command a sizeable market alone. INSTA-PRIN will be carried by EMC, police, and anyone who needs immediate drug intervention at the signs of stroke or heart attacks. Major pharmaceutical firms have soluble aspirin products in Europe, the Middle East, and Asia, BUT: None meet the USP requirements for marketing in the USA All are either sodium or calcium based All require several minutes to dissolve and leave residue and undissolved particles in the liquid Alka-Seltzer, the only soluble aspirin in the US, has a high sodium content and is sold as an antacid/pain reliever and not a daily pain reliever and arthritis treatment If ASPIR-TEK only achieves.5% market share over the next five years, it s sales will exceed $100 million dollars. This does not include the COX 2 arthritis market and prescription migraine market which, can easily triple the sales. To achieve these levels of sales, additional monies will be required to succeed.
Marketing & Sales Strategy In the US, no oral competing products exist, in terms of potency, rapid onset of action, and gastric tolerance. Neither does any competing product exists that can deliver a comparably high percentage of un-degraded salicylates per analgesic or cardio protective dose. 1. It will, for this reason, be strategically launched in such target sectors as AARP, hospitals and nursing home pharmacies, and by direct marketing, with detail samples and technical data, to medical professionals, as well as via special 2-for-1 buying incentives for distributors. Internet banners, infomercials, and consumer hot-lines will likewise be deployed after the initial 6 months, as will dedicated e-commerce, permitting direct purchase of AQUAPRINTM from The Company. A special information and product campaign will be aimed toward emergency medical service organizations. 2. The Company recognizes the cost and difficulty for a new product to secure prominent shelfspace in drugstores. The company will initially, during the first phase of funding, depend on vigorous sales promotion and highly visible point-of-purchase displays at high-traffic consumer corridors. The company feels that the product is so superior to all other OTC pain relievers, that once tried with free samples, the public will want the product. Also, local-media coupons and direct marketing will be creatively deployed by the Company to get its products distributed. The company will also make a strategic alliance with a major pharmaceutical distribution company. 3. The Company s strategic marketing plan includes English/Spanish promotional, packaging and medicinal insert formats. Overall Hispanic growth demographics show manifold increases in every quadrant of this population sector over the past 3 decades. AQUAPRINTM s bilingual debut also translates into easier brand-recognition and penetration of Mexican, Central and South American markets as soon as practicable.