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Next Safety Inc.
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Next Safety’s Pulmonary Delivery Platform (PDP) painlessly delivers medications through the lungs into the blood stream. It is a powerful new way to treat, and monitor many diseases and chronic medical conditions. It provides doctors with a new alternative to traditional treatments. In addition, PDP devices integrate with broadband technology, directly linking health care professionals and patient using cell phones, computers, and other means. The Company has demonstrated prototypes at various stages throughout product cycle. For example, the miniaturization of the nicotine delivery device has reached a small 106 gram product (less than 4 oz.). After complete miniaturization (e.g. utilizing a single chip ASIC solution etc.) the device will be far more powerful and much smaller.
Why Pulmonary Delivery?
The surface area of human adult lungs is similar to that of a small apartment, between 550 and 1,100 square feet. The primary role of the lung is the exchange of oxygen and carbon dioxide. Gas exchange occurs in the roughly 300 million alveoli, which are spherical outcroppings at the end of approximately 20 branches of conducting airways. The lungs provide the most direct route of entry for medications into the bloodstream. Once in the bloodstream, medications gain access to all parts of the body including the brain. For psychoactive substances such as nicotine, pulmonary delivery has long been recognized as the most efficient route of delivery. Pulmonary drug delivery has been limited to this point, due to an absence of technology that allows this route to be utilized.
Seventy years ago, methods to allow intravenous drug delivery were developed. Intravenous delivery is the channeling of liquid substances directly into a vein. Today, intravenous therapy is $100+ billion global market. Unfortunately, intravenous therapies have complications, some of which are life threatening.
INHALATION MARKET
According to the latest World Health Organization estimates (2007), currently 300 million people suffer from asthma and 210 million suffer from chronic obstructive pulmonary disorder -COPD. Asthma is the most common chronic disease among children and the leading cause of hospitalization. The prevalence of asthma increased 75% from 1980-1994; asthma rates in children under age five increased more than 160% during that time period. Three million people died from COPD in 2005. Fatalities are projected to increase by more than 30% in the next ten years. The disease is poised to become the third leading cause of death worldwide by 2020.
The value of the inhaled drug market has been estimated at $18.5 billion globally for 2006. As can be seen from the chart below, asthma and COPD represent the largest market segment, 65%, of the inhaled drug market worldwide. The chart also illustrates the many market opportunities for inhaled drugs. The world market for asthma drugs is expected to exceed $21.94 billion by 2010 with the US market accounting for approximately half of the global total.
In terms of revenue, the asthma and COPD therapeutics area historically ranks as the 6th largest single source of sales revenue for the pharmaceutical industry. The entire respiratory market is the 4th largest therapeutic area by sales and generated nearly $32.4 billion globally in 2005. Sales have grown steadily in the US and account for approximately 54% of global respiratory sales. The rise in the incidences of asthma and COPD combined with the possibilities of delivering many other medications through inhalation create a significant market opportunity. In addition, as pipelines weaken and many blockbuster drugs are coming off patent, the pharmaceutical companies are scrambling for new sources of revenue.
SUPERIOR TECHNOLOGY
The value of Next Safety’s pulmonary drug delivery platform (PDP) derives from the simplicity of its design and its ability to incorporate a wide set of highly desirable and customizable features. Next Safety’s PDP devices deliver medications that can be dissolved in water. Almost all medicines given intravenously fit this description. Next Safety’s PDP targets both currently marketed treatments as well as new drugs in development. Moreover, the PDP provides a clearly superior alternative for the efficient delivery of drugs which cannot be administered orally or intravenously.
DRUG “COCKTAILS”
Certain disease states are optimally treated by multiple medications. A severe asthmatic may take a short acting bronchodilator, a long acting bronchodilator, and an inhaled steroid. Currently, this requires multiple inhalers. Today, a two month old receives four vaccinations at a two-month well child visit; including, a DPT, hepatitis B, haemophilus influenza, and a streptococcus pneumonia vaccine. This requires four individual injections. The PDP provides the means of painlessly delivering medicines sequentially or all-but-simultaneously by varying, on a breath-by-breath basis, the drug(s) being delivered.
REVOLUTIONARY TECHNOLOGY
Imagine an asthma device that not only delivers medicine but also automatically monitors nitric oxide levels or pulmonary function. The PDP could send this information to a caretaker or a healthcare provider through instant messaging. The asthma device can also include an “emergency button,” which when depressed increases the dose while emergency services are contacted. In theory, the combination of the PDP with insulin, glucometer technology and simple programmable logic represents an artificial pancreas.
WIDE ARRAY OF APPLICATIONS
The following list is intended to illustrate how current medication classes might exploit the PDP.
1. Antibiotics
Non-invasive systemic delivery of antibiotics currently available only by intravenous (IV) delivery has an immediate market. Patients suffering from osteomyelitis, endocarditis, or complicated wound infections are currently treated for weeks with IV therapy. Long term IV access is associated with life threatening complications including line infections and line-induced thrombosis. Next Safety’s device could provide a non-invasive route for these same medicines.
Treating patients who have chronic lung disease with antibiotics is another frequently encountered problem in medicine. Patients with Cystic Fibrosis spend weeks in the hospital to treat their lung infections. An inhaled form of tobramycin is currently used to treat some bacteria successfully. The PDP could be used to deliver essentially any IV antibiotic directly to the lungs non-invasively.
The PDP has the potential to significantly benefit the treatment of tuberculosis. Isoniazid, while effective against TB, has highly toxic liver side effects. Delivering isoniazid directly to the lungs may allow a decrease in the total dose without compromising efficacy. The PDP would also provide a user-friendly route for streptomycin to treat TB. Although streptomycin is effective, the fact that it can only be given intravenously limits its use for treating TB.
2. Analgesics
The delivery of narcotics and benzodiazepines may be improved by the PDP because it would allow the use of these medicines in a home hospice setting. Moreover, in environments where IV access is troublesome, such as a battlefield or the scene of an accident, the PDP would be valuable because IV analgesic delivery is rare, if available at all.
Also, breakthrough treatments for migraine headaches and other episodic pain conditions can be developed by the rapid delivery of small amounts of medications. Immediate and relatively long lasting pain relief may be possible.
3. Anti-emetics
The last thing someone with nausea wants to do is put something in his or her mouth. Rectal delivery is not popular either. Drugs such as Phenergen or Zofran for anti-nausea would have significant benefits via pulmonary delivery by stopping nausea almost immediately (in sharp contrast to current approaches).
4. Pulmonary specific vasodilators
Flolan or prostacyclin is a constant infusion used for the treatment of primary pulmonary hypertension. Although an inhaled form was developed, it is not used because it is not practical with current nebulizer technology. It is therefore delivered intravenously, which necessitates continuous IV access. Side effects of continuous IV access and sudden changes in dosing are often life threatening. Bosentan is another common pulmonary vasodilator that is associated with serious liver toxicity. The PDP could simplify the delivery of these medicines and reduce side effects by delivering them directly where they need to act – namely, into pulmonary circulation.
5. Nicotine Replacement
In typical use, none of the current nicotine replacement therapy formulations achieves nicotine levels like those seen during typical smoking, leading to the idea that higher doses may be needed. The PDP delivers nicotine with higher efficacy than a cigarette. Importantly the PDP delivers nicotine safely, unlike cigarettes.
6. Vaccines