AUTOINJECTOR

SAFELIATM AUTOINJECTOR DESIGNED TO BE PATIENT AND SYRINGE FRIENDLY Nemera’s has developped a new generation of 2-steps autoinjector for fl uid and viscous injections. SafeliaTM autoinjector has been designed to ease patient self-injection experience. SafeliaTM delivers formulations in glass syringes, from fl uid small molecules to challenging highly concentrated biological formulations (viscous, sustain released, larger volumes …) in subcutaneous or intramuscular layers.

Injectable formulations are the fastest growing segment SafeliaTM autoinjector platform can be tailored to: in the pharmaceutical landscape. Biologic therapies are • administer a wide range of formulations and injection increasingly used to treat a wide range of chronic diseases volumes; the platform can be adapted through design to requiring frequent drug administration over a long period of handle liquid to highly viscous formulations, especially time. Developing drug delivery devices capable of injecting biologics, sustain released formulations and shear sensitive the pipeline of biological molecules is a challenge as molecules up to 2,25ml injection volumes biotherapeutics tend to be more viscous, concentrated and • improve patient experience, with the possibility to reduce administered in a larger volume. needle Gauge, reduce injection time, slowing down the The injection device should also deliver with possibly less needle penetration inside the body tissues and giving pain, less bruising and over a short delivery time. This can the possibility by design of a delayed automatic needle further contribute to issues with patient compliance. retraction for viscous injections especially. Nemera’s SafeliaTM autoinjector platform has been designed to respond to the challenge of handling new formulations while improving patient compliance.

BREAKTHROUGH AUTOINJECTOR TECHNOLOGY SAFELIATM - 2-STEP AUTOINJECTOR (AI) FOR 1ML AND 2.25 ML FLUID AND VISCOUS FORMULATIONS

Expected benefi ts Standard AI SafeliaTM AI Features

Creating possibilities Injects fl uid and for viscous injections with the same viscous drugs up AI platform as for standard glass syringes to 1000 cP

Risk of syringe fl anges breakage eliminated No stress on syringe Possibility of using all (or no) syringe fl anges fl anges

Enables increased spring force and use No stress on syringe of small gauge needles (less patient pain) without risk of glass breakage fl anges

Adjust needle insertion Reduction of pain at needle insertion speed

Reduction of pain during injection No initial injection peak

Needle insertion disconnected from Drug is delivered at the right depth injection The SafeliaTM autoinjector couples the syringe inside the device around the syringe shoulder (neck area) as opposed to a more common design approach of coupling the autoinjector with the syringe at the flanges, which is a structural weak part of the syringe. In the SafeliaTM autoinjector design, the spring release shock and the energy is absorbed by a rotating cam system and the energy is transmitted, attenuated, to the glass shoulder, in compression. Risks of breakage are therefore reduced by design during the trigger of the autoinjector but also during transportation, drop and handling.

SAFELIATM MARKETED AUTOINJECTOR

SafeliaTM autoinjector (Nemera) Marketed autoinjector (competition) • Syringe held by the shoulder inside the device • Syringe held by the flange inside the device • Reduced stress transmission on syringe (as an example, • High stress level (as an example, with a 19N spring, with a 19N spring, max 92 MPa Von Mises stress 201MPa max tensile stress calculated at the flange level) calculated at impact location, on syringe shoulder) and long shock wave propagated along syringe barrel • Von Mises stress is in compression • Von Mises Stress is in extension (higher facturing risk)

Nemera’s SafeliaTM autoinjector is now ready to be customized to match your formulations delivery specifications. Consult us for details.

Nemera has a well-known and established reputation in designing, developing and industrializing parenteral devices. As an example, every day over 5 million diabetic patients rely on devices manufactured by Nemera. Our four manufacturing sites share harmonized high standards of quality. To develop new standards of excellence in Drug Delivery Devices, we rely on the expertise of our Innovation Center. SafeliaTM development benefited from the implication of creative design engineers and human factor specialists, mechanical engineering, testing in our world-class laboratory, manufacturing and assembly knowledge and extensive mathematical modeling.

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