IIS INNOVATIVE INJECTION SYSTEMS NEW PERSPECTIVES, MORE POSSIBILITIES

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1 IIS INNOVATIVE INJECTION SYSTEMS NEW PERSPECTIVES, MORE POSSIBILITIES

2 IIS REVOLUTIONARY ADMINISTRATION TECHNIQUES MORE EFFICIENCY AND SAFETY IIS researches and develops innovative injection systems. Within this field we have specialized in two technologies: needle-free injection systems (NFI) and micro-needle systems (MNS). They deliver active ingredients directly into the body through the skin. This offers decisive benefits compared with other forms of administration. 2

3 Benefits of innovative injection systems From feasibility to production As innovative injection systems use the skin to deliver active ingredients, they are superior in many respects to other forms of administration. This provides benefits to patients, health-care professionals and partners from the pharmaceutical industry. From the initial discussion about feasibility studies, preclinical and clinical tests up to large-scale production, we are an innovative partner for the pharmaceutical industry. As a part of the LTS Group, IIS has access to: Cost efficiency clearly reduced amounts of active ingredients with the same/improved bioavailability Therapy optimization fewer side effects through transdermal administration Higher patient acceptance clearly improved compliance possible R&D center for the aseptic manufacture of NFI and MNS systems Interactive GMP area Access to CRS of the LTS Group Expertise in the formulation and development of new technology platforms Suitable for NCEs, NBEs, vaccines and small molecules High level of user safety and therefore lower risk of injury and fewer cross infections NFI Needle-free injection systems MNS Micro-needle systems 3

4 NEEDLE-FREE INJECTION SYSTEMS GROUND-BREAKING INNOVATION Our needle-free injection systems (NFI) make it possible to deliver active ingredients directly into the skin. Basically this means liquids are administered micro-fine practically lesion-free at a high pressure. IIS 100 CS 100 µl, spring powered Highly potent APIs and vaccines Status of development: available as a prototype IIS 500 CS 500 µl, spring powered MABS, interferons, proteins, peptides, NBEs and NCEs Vaccines and pharmaceuticals Status of development: GMP for clinical trials 4

5 Form of administration The administration of NFIs is almost entirely pain-free. This is an important benefit compared with conventional injection systems. On top of this, the IIS NFI system achieves a high degree of safety. Accidental needlestick injuries and the resulting cross infections can be avoided. The systemic availability of active ingredients is higher for the administration route through the skin than with oral administration. And not least, NFI systems offer benefits through their discrete and easy usage. They are also extremely suitable for self-administration. Two systems can be adapted to your active ingredient We have developed two different NFI systems to ensure optimal adaptation to different types of active ingredients. First, the IIS 100 CS. This NFI system administers 100 µl liquid containing active ingredients. It is ideal for highly potent active ingredients and vaccines. Second, the IIS 500 CS is available. This NFI system administers 500 µl liquid containing active ingredients. It opens up new potentials for NCEs, NBEs, proteins, peptides, interferons but also for vaccines and pharmaceuticals. Benefits of the IIS NFI system: Highest level of safety, efficacy and pharmaceutical quality when administrated Prefilled and sterile Simple and economical device design can be adapted to the customer s wishes Adaptable to the API Ideal for patients with needle phobias No needlestick injuries, no cross infections Patient-friendly through simple, discrete and convenient self-administration 5

6 MICRO-NEEDLE SYSTEMS A NEW WAY OF LOOKING AT INJECTIONS Our micro-needle system (MNS) combines the benefits of the transdermal therapeutic system (TTS) with the innovative micro-needle technology. The micro-needles integrated into the patch penetrate into the uppermost dermal layer. This is pain-free. The route through the skin Micro-fine needles penetrate into the uppermost dermal layer. The active ingredient is administered through channels in the micro-needles or after the needles dissolve. MNS API administration The active ingredient is continuously administered into the skin. The medication can also be delivered over a longer period of time. 6

7 The new generation of TTS The new generation of TTS patches The technological know-how of IIS combines perfectly with the unique expertise of LTS in the field of TTS. That puts us in the position of being able to adapt the MNS system quickly and effectively to all existing and newly developed active ingredients. MNS can be used to deliver liquid and dry active ingredients into the body. The benefits are: dry active ingredients do not need to be refrigerated. This opens up completely new perspectives such as the use of MNS for the administration of vaccines in developing countries µm small needles are integrated into our MNS patches. They can be made of different materials such as ceramic, steel, polymer or silicon. An important benefit of MNS: Just like TTS, they deliver active ingredients quickly and consistently into the body. This makes it possible to achieve a consistent concentration of active ingredients in the blood over a longer period of time. Because the active ingredients do not have to pass through the gastrointestinal tract and the first-pass effect no longer applies, the pharmacologically active substances are delivered directly and at the right dose to where they are needed in the body. Benefits of the IIS NFI system: Improved immune response Pain-free and simple to use No needlestick injuries Greatly expanded potential areas of application No need of the cool chain under certain circumstances For biologicals, vaccines and small molecules Broad TTS technology platform available 7

8 IIS Innovative Injektions-Systeme GmbH & Co. KG Lohmannstraße Andernach Germany Phone: +49 (0) Fax: +49 (0) info@ltslohmann.de LTS GROUP SYNERGIES THAT PROMOTE INNOVATIONS IIS is a part of the LTS Group. That means we belong to a network whose expertise in the area of transdermal delivery of active ingredients is unique all over the world. LTS developed the first transdermal therapeutic system (TTS) over 30 years ago. They then went on to produce many more globally successful products, which LTS together with partners in the pharmaceutical industry were able to develop and produce in quantities for the world market. LTS know-how has been fused with the technological innovative power of IIS since Thus a partnership was formed whose revolutionary vision for innovative injection systems laid the foundation stone for groundbreaking new products for the pharmaceutical industry.