Go for the complete package.

Our services help you stand

out in the market.

Individual design options while leveraging the benefits of a device platform Flexible prototyping and devices for early studies Human factors engineering from concept to final patient specific design Flexible drug & device assembly expertise and support Complete device support for registration of the combination product More confidence. More success. With Ypsomed Delivery Systems.

Go for the

complete package.

YDS Extended Services Ypsomed not only provides innovative, reliable and easy to use injection devices but also a range of extended device services to pharmaceutical and biotech companies to allow them to focus on their core competence of drug development. For all device related aspects Ypsomed offers support tailored to the needs of each project: From industrial design, human factors engineering and IP landscape management to trainer devices, final assembly infra-structure and registration support. Read on to learn more about these services that add value to your device project. Ypsomed Delivery Systems (YDS) is a leading, inde-pendent developer and manufacturer of injection systems for self-medication with over 30 years of ex-perience. From technical development and design to manufacturing and packaging, YDS makes a crucial contribution to the safety and market success of drug products. YDS is a leader in innovation and techno logy and the preferred partner of pharmaceu-tical and biotech companies in the self-medication field worldwide. Its product range reflects many years of experience and competence in the field of injection systems. This expertise not only helps YDS to stand out in the market – it also helps customers to stay one step ahead of the competition. Ypsomed offers a broad range of pen and autoinjec- tor platforms for use with standard cartridges, dual-chamber cartridges and syringes.

YDS Disposable and Reusable Pen Systems

Ypsomed’s broad range of injection pens covers reusable and disposable injection systems for the treatment of diabetes, growth disorders, infertility, osteoporosis and other indications where liquid stable or lyophilized drugs are provided in cartridges for frequent injections.

YDS Flexible Volume Autoinjector Systems

cover a broad range of syringe-based disposable devices for the growing range of infrequently inject- ed long-acting and antibody-based drugs. Autoin-jectors are triggered by push-on-skin activation which is convenient, ergonomic and preferred by patients.

YDS Contract Manufacturing

leverages Ypsomed’s broad expertise for the de-manding manufacture of injection devices, using semi-automated as well as fully automated manu-facturing infrastructure for high volume production.

Ypsomed Delivery Systems

Individual design makes the difference

Your own design built on proven platform advantages

As the number of devices reaching the market increases, pharmaceutical and biotech companies are looking to source state-of-the-art devices that are available quickly and at low risk for both clini-cal trials and commercial launch. A self-injection device should provide product differentiation through improved human factors and increased safety com-pared to vial-syringe and pre-filled syringe product presentations. At the same time pharma companies strive to differentiate their own self-injection device from devices used by competitors. As an answer to these requirements, Ypsomed has built up comprehensive platform products, which only require simple customisation projects to fit to the specific primary container. The standard designs of these platform products are ergonomi-cally proven and tested. In addition, different colours and colour combinations can be selected. If specific patient groups or demand for differentia-tion in a specific market calls for a completely new outer shape, Ypsomed is in a position to offer a new device version with custom design that still relies on proven platform technology. Either the outer design is changed within the defined limits of the manufacturing equipment or the device such as the YpsoMate® _{autoinjector utilises an outer shell} structure that allows freedom to generate a unique, pleasing and ergonomically optimised shape. In addition to the flexibility of designing free-form designs it is possible to use different surface materials or structures to improve the grip and to emphasise how to hold and use the device. Ypsomed is open to work with customers’ design partners or works with its own industrial design partners to propose patient group specific individual industrial designs. We understand that flexibility is key. YpsoMate® _platform YpsoMate® _{Design – a version of the proven YpsoMate}® platform autoinjector with a fully customisable, individual industrial design

Fast and reliable device selection process

Rapid design and supply of prototypes for different study purposes

Human factors engineering

Keeping the patient in focus

Human factors engineering is essential for the development of a platform resulting in safe and effective devices that motivate patients to adhere to their therapy. Based on over 30 years of experience in device development and having marketed doz-ens of devices globally, Ypsomed has substantial knowledge of all relevant guidelines and standards Device design and innovation is not only about pre- senting creative ideas and solutions. Equally impor-tant is the capability to evaluate and test concepts as they arise and mature. Ypsomed’s development toolbox comprises the latest methods such as finite element analysis and mathematical modelling to virtually refine our designs and ensure that only the best solutions are taken on to the next stage. The ability to quickly prepare prototype parts and devices at different stages during a project is central to device development. As a design pro-gresses, the requirements on quantity and quality of prototypes also evolve. Our rapid prototyping setup is capable of delivering single parts within hours, while prototype tooling is prepared within weeks to produce larger numbers of devices. This not only helps streamline the development process but also flexibly supports customers for preference studies, formative studies and other development work where devices are needed. and broad experience putting this knowledge into practice. As part of platform development during the concept phase, we ask users for their prefer-ences and conduct formative studies to ensure the platform meets the expectations of patients for an easy to use, discreet and safe device. This supports further patient specific formative and summative studies once the platform is customised for a specific patient group. Ypsomed fully sup-ports its customers during these formative as well as summative human factor studies, thus contribut-ing significantly to the success of the registration process and resulting in devices that always have the user in mind.

Trainer devices

Ensuring optimal patient education

Drug & device assembly

Flexible solutions fully prepared

Combination products are only complete when device components and the primary drug container are assembled, labelled and packaged. Drug and device assembly often takes place at the filling site to reduce time, risk and transport costs. The assembly process requires broad knowledge and experience, which is often not the core competence of the filling site. Ypsomed’s drug & device assem-bly support is the ideal solution to ensure that the final combination product is assembled according to the underlying device specifications and fulfils all requirements. Ypsomed works closely with well-known equipment manufacturers to provide ready to order final as-sembly solutions that are tailored to device specific requirements such as assembly forces and inline controls. Assembly systems for low (<150,000 p.a.), mid (<1 million p.a.) and high volumes (>1 million p.a.) are available and several lines have already been supplied to pharma customers and contract filling sites. Ypsomed also offers on-site support at the final assembly site with experienced industriali-sation engineers as required. The trend to longer acting formulations and infre-quent injections means that some patients are not used to the routine of their therapy. Furthermore, drugs that are injected as infrequently as once per month may be expensive single shot presentations. Pharma companies, payers, doctors and patients want to be sure that the injections are performed correctly without wasting drug. This is where reus-able trainer devices allow patients to practice in a clinical or home environment before performing their first or subsequent injections. Ypsomed offers trainer devices and fully supports customers in providing a complete training pack-age to doctors or patients.

Ypsomed has broad experience in the field of regulatory submissions for injection devices and combination products. The number and broad range of devices Ypsomed has launched with cus- tomers speaks for itself. A dedicated team of regu-latory experts provides dossier support for each project. Ypsomed supports registration following either the Common Technical Document (CTD) or the Master File (MAF) approach:

Dossier support

Over 30 years of regulatory expertise

A CTD is mainly used in the ICH region. Ypsomed issues the relevant CTD sections with device relevant information (for inclusion in 3.2.P). The customer issues the drug relevant parts and submits both drug and device sections to the regulatory authorities. The MAF approach is primarily used in the US. Ypsomed submits a Master File that contains the relevant device information and issues a authori- sation letter that is referenced to in the custom-er’s submission documents. The agency then reviews the submission and has access to the MAF data. Dossier support is an integral part of each project at Ypsomed. We help customers to streamline the device-related process and allow them to concentrate on the drug-related part of the submission. Regional administrative information Module 1 Not part of the CTD The CTD Module 2 Non-clinical overview Non-clinical summary Quality overall summary Clinical summary Non-clinical study reports Module 4 Quality Module 3 Clinical study reports Module 5 Clinical overview The structure of the CTD. The device relevant information is part of Module 3 Through our extensive experience with devices, we at Ypsomed have acquired a profound understand- ing of the injection device patent landscape. Our de- sign engineers work closely with in-house and exter- nal patent specialists to ensure that all device solu-tions are provided with solid intellectual property protection and do not infringe third party patents.

Intellectual property assurance built into every product

Providing protection and managing complex patent landscapes

In addition to actively protecting our innovations, we constantly monitor the patent environment and thus possess a comprehensive and in-depth knowledge of the self-injection device patent landscape. With numerous patent families with granted patents as well as patent applications in key countries for in-novative injection device technologies, we possess a unique basis for custom developments and tailor-made intellectual property solutions.

Clickfine® _{pen needle and Clickfine}® _AutoProtect™ _safety pen needle Ypsomed’s tireless commitment to provide custom-ers with innovative and state-of-the-art injection systems is complemented by a range of services that help our customers to stand out in the market: Specific customized and exclusive design options while still leveraging all the advantages of a platform product Flexibility in manufacturing prototypes from rapid prototyping and prototype tooling to support different study needs such as preference or for-mative studies

Clear patient focus based on a deep under - standing of human factors engineering and patient training

Benefit from Ypsomed’s services

Always one step ahead

Flexible approach and support for a complete range of possible drug & device assembly solutions Dossier support to streamline the registration process so that customers can concentrate on the drug related part of the submission Active protection and continuous monitoring of the intellectual property landscape to safeguard our customers’ products Unrivalled pen needle systems that meet the highest quality standards and improve the injec-tion experience for the patient Ypsomed is one of the world’s largest pen needle manufacturers selling pen needles in over 50 coun-tries. Ypsomed offers Clickfine® _{pen needles with the}

unique click-on technology that patients around the globe know and trust. This patented function allows the patient to simply push the needle onto the pen without twisting. Ypsomed is the only manufacturer to offer pen nee-dles with a DiamondTip 6-bevel cannula, which allows an even smoother injection. Over 77 % of users who surveyed the new bevel design (n = 150) reported less pain during injection compared to their current pen needle.

Ypsomed also offers Clickfine® _AutoProtect™ _safety

pen needles with a patented locking mechanism for protection against needlestick injuries that conforms to the 2010/32/EU directive. The safety locking mechanism locks automatically after injection and prevents reuse.

Complete your patient offering with dedicated pen needles

Unique patented click-on technology and built-in safety

Ypsomed offers flexible pen needle packaging – either as bulk or in boxes – with customer specific branding of the peel foil and outer packaging. Ypsomed pen needles may either be registered by the customer with support from Ypsomed or Ypsomed takes on the role of the Market Authorisa-tion Holder depending on the market. An injection device and a pen needle from Ypsomed not only result in shorter timelines and reduced pro-ject risks. We support our customers to stand out in the market thanks to the combination of injection device and state-of-the-art pen needle, resulting in the best possible injection experience for the patient.

More confi dence.

More success.

With Ypsomed Delivery Systems.

Pen systems Autoinjector systems Contract manufacturing Extended services

Ypsomed Delivery Systems provides a complete range of products and services for dedicated drug delivery devices from development and design to manufacturing and packaging, giving more confi dence and leading to more market success.

Company movie

For more information visit www.ypsomed.com/yds

Ypsomed AG // Brunnmattstrasse 6 // 3401 Burgdorf // Switzerland T +41 34 424 41 11 // [email protected]

10083873-MSTR-en/V01