Norwood's primary focus is the development of technologies that solve drug delivery problems.
There are a variety of drugs that work very well in the 'test tube', but because they are degraded by either the acids or enzymes in the stomach, or by the effect of the liver, that they have relatively little or no effect on the illness being treated. Norwood focuses on innovative technologies to address specific drug delivery problems.
Norwood's drug delivery technology development programs incorporate the use of nanotechnologies where applicable. The core of nanotechnology consists of systems in the size range of nanometers. Nanotechnology is the ultimate in engineering precision and control, and is operating at the scale of atoms and molecules. It ignores the boundaries between the disciplines of physics, chemistry and biology.
Norwood has three device-based drug delivery technologies which can be applied to a range of drug delivery problems:
- Needle-free Drug Delivery
- Micro-needle Drug Delivery
- Laser Assisted Drug Delivery (LAD)
Needle-free injection technology will eliminated the dangers to health care workers caused by needle stick injuries. It is estimated that more than one million sharp injuries occur every year world wide, by objects such as needles, blades, lancets, knives and any other sharp items. As a result of widely-publicised risks of needle-stick injury associated with conventional injections, legislation has recently been passed in the United States which requires employers to provide safety features in sharp medical devices.
Norwood and its research partner Massachusetts Institute of Technology (MIT) have developed a Needle-free injector system. The Needle-free injection device is designed for both human and veterinary applications. The drug is delivered through the skin using a small handheld device. The system uses a novel, patented and extremely fast and powerful contractile fibre-activated pump that fires the drug at the skin with sufficient velocity to penetrate without the use of needles.
The Norwood Needle-free injector system addresses all the parameters that have been identified as crucial for an ideal needle-free system. Key features of Norwood's Needle-free injector system are:
- It is silent
- It is safe
- It has a low cost per procedure
The basis of the technology is the use of very fast contracting shape memory alloy fibres. The shape memory alloy fibres (typically an alloy of nickel and titanium) are activated using a brief electrical pulse whose initiation, duration and general shape are controlled by an embedded computer. These fibres can be designed to contract and produce significant forces. Additionally the Needle-free injector system has computer control to vary dosage and delivery force dependent on individual skin type.
Norwood has licensed a key patent for the technology from McGill University and has filed a large number of USA patents on the core technology to strengthen its intellectual property position.
The Norwood Needle-free injector system overcomes key concerns with some of the existing needle-free injection devices. Existing needle-free injection devices typically use either compressed gas or, via a fast chemical reaction, produce a gas (similar to an automotive air bag) to force a fixed quantity of drug out through a small orifice at a velocity that is high enough to penetrate skin.
The Norwood Needle-free injector device has been designed to overcome the limitations of existing systems.
Norwood in conjunction with its sponsored research partner, Massachusetts Institute of Technology (MIT) in Boston, is developing small, sophisticated device which uses micro-needle arrays for the transdermal delivery of various drugs.
- Miniaturised narrow-bore needles and pumping mechanisms for controlled delivery of drugs through the skin
- Programmable to control delivery over time and to a controlled depth
- Non-disposable, re-usable applicator
- Non-disposable, reusable delivery module
- Disposable micro-needle drug capsule
A key area of focus for the research at MIT is for the delivery of biologically based drugs. This group of drugs is a growth in pharmaceutical development and is key to the discovery of new therapeutic compounds. It is, however, also the class of drugs that is the most difficult to administer.
Norwood's initial targets for the new delivery system is these higher priced biological drugs. The new delivery system is expected to have almost universal applicability to deliver any drug in a timely, practical and cost-effective manner.
Controlled drug delivery - the purpose behind controlling drug delivery is to achieve more effective therapies while eliminating the potential for both under- and overdosing. Providing control over the drug delivery can be the most important factor at times when traditional oral or injectable drug formulations cannot be used. These include situations requiring the slow release of water-soluble drugs, the fast release of low-solubility drugs, drug delivery to specific sites, drug delivery using nanoparticulate systems, delivery of two or more agents with the same formulation.
The ideal drug delivery system should be inert, biocompatible, mechanically strong, comfortable for the patient, capable of achieving high drug loading, safe from accidental release, simple to administer and remove, and easy to fabricate and sterilize. With traditional tablets or injections, the drug level in the blood follows the profile shown in Figure 1a, in which the level rises after each administration of the drug and then decreases until the next administration.
The key point with traditional drug administration is that the blood level of the agent should remain between a maximum value, which may represent a toxic level, and a minimum value, below which the drug is no longer effective. In controlled drug delivery systems designed for long-term administration, the drug level in the blood follows the profile shown in Figure 1b, remaining constant, between the desired maximum and minimum, for an extended period of time.
Laser Assisted Drug Delivery (LAD)
The LAD is designed to painlessly and temporarily alter the stratum corneum, or outer layer of skin, to potentially enable drugs to be effectively delivered transdermally avoiding the gastric side effects associated with oral drug administration. Our research has indicated that a wide range of drugs can potentially be better delivered via the use of Norwood's LAD technology. Clinical studies have shown that LAD ablation of the stratum corneum allows 4% lidocaine to more readily penetrate through the skin thus enhancing the delivery of dermal anaesthesia. The LAD device has been cleared for marketing by the Australian TGA and the USA FDA for the delivery of a topically applied local anaesthetic.
The concept for the LAD delivery technology originated from research at the Massachusetts General Hospital (MGH) - the teaching hospital for the Harvard University Medical School. Norwood has an exclusive worldwide license over the MGH patent for the use of lasers to assist in transdermal drug delivery. Norwood has built on this base patent and now have 18 patents and patent applications covering all aspects of laser assisted drug delivery for the removal of bodily fluids for diagnostic purposes.
In a large number of instances, the transdermal delivery of drugs has many advantages over the traditional methods of administration orally or by injection. It eliminates many of the problems associated with solid dose or liquid formulations, including first pass liver clearance, toxicity and gastric degradation.
The effects of the laser treatments are extremely mild, involving a rearrangement of lipids and proteins or removal of dead cells. As the outermost layer of skin does not contain any nerve endings, laser removal of skin to enhance percutaneous transport of pharmaceuticals, chemicals or allergens is completely painless.
The use of Norwood's laser technology has the potential to deliver a large number of drugs that cannot currently be delivered either orally or by injection, as well as substantially improving the efficacy and effectiveness of delivery of drugs currently administered transdermally.
The technology is an attractive alternative to oral drug delivery as well as drug delivery via injections by conventional needles and syringes. Historically, the major hindrance to transdermal delivery of drugs and biologics has been the near impervious nature of the outer layer of skin or stratum corneum.
The stratum corneum acts as a waterproof barrier, preventing entry to all but a few small molecular compounds. The majority of drug molecules are too large and chemically different from skin cells to pass through the stratum corneum and therefore have to be injected or taken orally.
Clinical Studies
Clinical studies conducted under FDA Investigational Device Exemption (IDE) showed the laser removal of the stratum corneum results in a significant increase in the permeation of a topically applied local anaesthetic (4% lidocaine).
Safety and Efficacy
In a controlled, randomized, multi-centre clinical study of 320 subjects, treatment with the LAD prior to a 5 minute application of 4% topical lidocaine (lignocaine) significantly reduced the pain associated with needle insertion. (Accepted for publication - Archives of Dermatology 2003.) The clinical study showed a low incidence of adverse events, all of which were minor in nature. The laser technology has been used safely in medicine for over 20 years. Norwood's safety features include contact activation of the laser and a disposable tip to ensure patient and operator safety.
- Painless alternation of the outer skin barrier
- Enhancing penetration of topical anaesthetics
- Rapid onset of dermal anaesthesia
- Clinically proven efficacy in just 5 minutes
- Simple and safe operation
- Handheld and portable
For more information on Laser Assisted Drug Delivery, visit www.epitureeasytouch.com
Norwood EyeCare's Epikeratome System for Epi-LASIK, is the next generation in laser vision correction surgery, offering patients significant improvements over current refractive procedures. Epi-LASIK utilizing the Norwood EyeCare Epikeratome System, replaces the need to cut a stromal flap and eliminates the associated complications.
The Norwood EyeCare Epikeratome System is a surgical/mechanical device designed to delaminate or separate the epithelial layer of the cornea above Bowman's layer. This Norwood EyeCare Epikeratome System eliminates the need for alcohol currently used during Laser in Situ Epithelial Keratomileusis (LASEK) to delaminate the epithelium. By eliminating the need for alcohol and providing a 'minimal-touch' surgical approach, the SES is designed to reduce trauma to the epithelial layer and avoid flap-related complications.
The Epi-LASIK procedure is a derivation of Laser in Situ Keratomileusis (LASIK) and LASEK. The procedure is designed to provide the surgeon with an intact epithelial flap or cap, which can be replaced after the laser ablation has been completed.
The Norwood EyeCare Epikeratome System:
- Creates an epithelial sheet
- Preserves structural stability and integrity of the cornea
- Eliminates the need for alcohol and other chemical
agents - No cutting involved as a result of bladeless separation
For more information on Norwood EyeCare, visit www.norwoodeyecare.com
Massachusetts Institute of Technology (MIT)
Norwood Abbey entered into a commercial phase licence agreement with Massachusetts Institute of Technology (MIT) in March 2006. The field of work includes the needle-free drug delivery system and the microneedle drug delivery system. A primary focus of the company is the delivery of vaccines, especially in the area of influenza and mass vaccinations.
The licence provides Norwood Abbey with an exclusive worldwide licence over all technological developments emerging from the contracted works programs. The licence covers ten patent families covering one issued US patent and some 50 applications. In return, MIT will earn a royalty from revenues generated by the products when commercialised. The needle-free system has potential application in both human and veterinary fields.
Norwood decided to exercise its rights for a formal license over the technology as a result of the successful development of working prototypes, and the very strong intellectual property position.
The research and development work is being undertaken at the world-renowned BioInstrumentation Laboratory at MIT, under the direction of eminent Professor Ian Hunter.
Norwood Abbey's Eyecare Division entered into a sponsored research agreement in January 2006 with the University of Crete relating to future research and development in the field of Epi-LASIK, refractive surgery and related ophthalmic innovations.
The research programs are conducted under the direction of Professor Ioannis Pallikaris, Head of the Vardinoyannion Eye Institute. Professor Pallikaris is recognised as the father of both LASIK and Epi-LASIK refractive surgical procedures. Dr. Pallikaris serves as President of the European Society of Cataract and Refractive Surgery and President of the European Academy of Ophthalmology. He is the President of the University of Crete.
Under the research agreement, Norwood Eyecare will have the right to commercialise all new technological developments arising from the scope of work within the ophthalmic unit at the University. The exclusive agreement places Norwood in a strong position in the Epi-LASIK market. It potentially provides Norwood with access to a considerable pipeline of future products in the field.
Dr Pallikaris and his team will work closely with Prof Ian Hunter of Massachusetts Institute of Technology, in seeking to generate leading-edge technologies in the eyecare field.
Norwood Abbey's associate company, Norwood Immunology is a company focused on technologies and therapies to rejuvenate activity of the immune system, through re-growth of the thymus, improvements in bone marrow function and enhancement of T cell functionality. Norwood Immunology publicly listed on the AIM exchange in London in 2004.
The project addresses significant unmet medical needs in the areas of cancer, viral infections and auto-immune disease. In view of the importance of the human immune system throughout life, we believe that the ability to rejuvenate the thymus has the potential to have a significant impact on many important medical conditions, diseases and treatments. The technology has been developed during over fifteen years of research by Dr Boyd and his scientific team at Monash University.
Norwood
Abbey believes there are very positive factors in regard to the future
development of Norwood Immunology in which Norwood has a substantial investment
and continues to be the largest shareholder with approximately 49 million
shares representing approximately 21% of the Company.
For
more information on Norwood Immunology, visit www.norwoodimmunology.com