tesa Labtec GmbH Innovative Drug Delivery Systemspharmasolutions

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drugdeliveryInnovative Patch & Film Technologies

T R A N S FI L M, R A PI D FI L M & MU C O FI L M2

Selecti ng the appropriate route of administrati on is an important issue in the development of a pharmaceuti cal product.

Therefore, tesa Labtec has focused on developing and manufacturing innovati ve drug delivery systems and has created the Transfi lm, Rapidfi lm and Mucofi lm technologies. Today, we serve a large number of clients in the pharmaceuti cal industry as Contract Developer and Contract Manufacturer.

Transdermal and topical patches the Transfi lm technology

Transdermal drug delivery provides clear advantages for the pati ent, due to easy administrati on, which does not restrict daily acti viti es. In additi on, this non-invasive delivery system combines a reduced fi rst-pass eff ect with constant drug levels and prolonged delivery over ti me to provide pati ents and clinicians with important benefi ts.

Transdermal patches off er a unique selling point for new and established drugs in competi ti ve markets. tesa Labtec has a proven track record of bringing transdermal patches to the market. Our estradiol patch for hormone replacement therapy has been marketed in 41 countries worldwide since 1995 and our fentanyl patch has been conquering the European market and Canada since 2005. In Germany, Europes biggest fentanyl patch market by far, our patch has become #1. Currently, we are developing the next generati on analgesic opioid patch.

Topical patches deliver the drug to the local site of acti on. This convenient and safe way of administering a locally acti ve drug off ers considerable advantages compared to gels and creams and is generally extremely well-received by the pati ents. tesa Labtec established innovati ve ways to apply this principle to other parts of the body. For example, our nail patch for treatment of fungal infecti ons of the nails is the fi rst of its kind.

Additi onally, the Transfi lm technology is uti lized for tesa Labtecs Labipatch which allows acti ve ingredients to be applied to the lips with an extremely thin patch, improving the treatment of cold sores.

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T R A N S FI L M, R A PI D FI L M & MU C O FI L M 3

Oral, sublingual and buccal fi lms the Rapidfi lm and the Mucofi lm technology

Oral, sublingual and buccal lms are placed on or under the tongue, or into the cheek. The great advantages of thin fi lms have made them an excellent alternati ve to tablets or capsules.

Our Rapidfi lm technology makes oral fi lms possible that dissolve and release the drug within seconds once in contact with saliva. It combines the applicati on ease of an oral soluti on with the stability and dosing accuracy of a tablet.

Rapidfi lm is the ideal takeaway medicine; it can be taken without beverages and is especially suited for pediatric applicati on.

We have developed several generic Rx Rapidfi lm products. Ondansetron Rapidfi lm obtained its marketi ng authorizati on from EU authoriti es in March 2010, making it the worlds fi rst Rx product to be approved that uses oral dissolvable fi lm technology. The product is marketed in Europe by Norgine under the tradename Setofi lm and in Canada by Takeda under the tradename Ondisolve.

Buccal fi lms are placed on the inside of the cheek. Sublingual fi lms are applied underthe tongue. Both systems enable local or systemic drug delivery.

Our Mucofi lm technology creates a mucoadhesive fi lm that enables transmucosal drug permeati on. Thus gastrointesti nal drug degradati on cannot occur and the hepati c fi rst-pass metabolism is bypassed. Therefore, buccal administrati on opens up completely new possibiliti es for molecules with low bioavailability. Mucofi lms are easy to apply, handle and store. Pati ents can benefi t tremendously from the prompt relief delivered by our Mucofi lm technology.

Today several buccal fi lms are under development by tesa Labtec GmbH.

Muco

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C D M O S E R V I C E S4

tesa Labtecs business model follows a purely B2B approach and addresses pharmaceuti cal companies need for innovati ve drug delivery systems. The model is based on three segments:

Manufacturing

Scale Up

Formulation Development

Lab Feasibility

Paper Feasibility

Internal Prototype

Development

ContractDevelopment

ContractManufacturing

Internal prototype development

We invest in the in-house development of patches and lms. As a result tesa Labtec possesses a project portf olio which is open to global licensing.

Contract development

When developing lm or patch products we follow a structured approach for eachproject accompanied by professional project management. We determine the goalof each project together with our customers and de ne milestones and interim targets for the development process. All results from experiments are presented and discussed within the joint project team on a regular basis, so that full transparency regarding the progress of the project is ensured. From a very rst paper feasibilty up to the approval of the product, our expert team is ready to support customers in all phases of a development project.

Our R&D site in Langenfeld, Germany, is tt ed with the most modern equipment for the development of innovati ve drug delivery systems. The formulati on department has direct access to all of the necessary development tools. Our in vitro testi ng group routi nely performs Franz cell tests. The analyti cal laboratory can o er a broad range of pharmaceuti cal testi ng from method development and validati on to long-term stability testi ng for registrati on purposes. State-of-the-art equipment and modern informati on technology ensure ti mely, reproducible results at a reasonable cost.

Integrated quality assurance procedures and full cGMP compliance guarantee reliable results. We possess all of the equipment and personnel quali cati ons necessary to manufacture clinical trial supplies under cGMP conditi ons. Our integrated service includes scale up and tech transfer acti viti es at our manufacturing site, located in Hamburg.

Our development approach:

With our presence in Europe and our o ce in the USA we serve the biggest internati onal markets and a broad variety of customers. This proximity to our customers ensures great accessibility and high responsiveness on inquiries.

serviceprovider

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C D M O S E R V I C E S 5

Contract manufacturing

tesa Labtec is prepared to support their customers as a full-range product supplier from R&D lab-scale over pilot-scale to full-scale producti on. Our faciliti es are equipped to serve customers at every stage of a products lifecycle and according to current producti on demand. The producti on plant in Hamburg, Germany, o ers state-of-the-art equipment compliant with all cGMP requirements.

LabFactory: In 2014 tesa Labtec opened its LabFactory, a fully automated pilot-producti on facility at the R&D site in Langenfeld equally operati ng under full cGMP. The new equipment provides the unique opportunity to close the gap between small-scale development and large-scale producti on. The LabFactory has been equipped to be comparable to our commercial-scale operati on in Hamburg. Thus, it allows the assessment of criti cal process parameters as well as a rst processability check of formulati ons already at an early stage of development.

However, the new LabFactory is also able to produce su cient volumes of patches and lms to supply even large phase II clinical trials directly from the R&D site.

Commercial producti on: tesa Labtecs producti on plant in Hamburg, Germany, is equipped with the latest state-of-the-art coati ng, converti ng and packaging equipment in a cleanroom environment. It is fully dedicated to manufacturing patches and thin lms.

Our coati ng lines o er variable coati ng widths, which allow us to perfectly match customers volume requirements, from small quanti ti es up to several hundred million units. Depending on our customers need, we produce bulk or secondary packed products. Machines and operati ng procedures are designed to ful ll the strictest legal and regulatory standards according to cGMP. If a reliable partner to scale-up a proprietary product formulati on is required or if an experienced supplier for a marketed product is needed, we are the right partner.

Our technological capability and our know-how related to material are propositi ons that customers can count on to keep ti ght project ti melines and reduce total processing costs. In additi on, our customers can bene t from the full supply chain and worldwide distributi on know-how of a tesa company.

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E X P E R I E N C E6

longstandingcompetenceCompelling Competence in Drug Delivery, Adhesives and Coating

With more than 25 years of experience, tesa Labtec is one of the leading drug delivery companies for film-shaped dosage forms like patches and thin films. Because of its innovative Transfilm, Rapidfilm and Mucofilm technologies, the company considers itself a highly specialized full-service Contract Development and Manufacturing Organization (CDMO).

tesa Labtec is a wholly owned subsidiary of tesa SE, a member of the Beiersdorf group of companies, and represents the pharmaceutical business in a truly global family of companies by offering Solutions for Pharma.

Our parent company, tesa SE, is one of the worlds leading manufacturers of self-adhesive product and system solutions for industry, trade and consumers. The companys 125 years of experience in coating technology and its development of adhesives and innovative product solutions have taken tesa to the top of the world market in many fields of application.

The unique combination of tesa Labtecs pharmaceutical development know-how with tesas broad engineering experience and expertise offers valuable synergies and advantages to our customers.

Compelling competencein drug delivery, adhesives and coating

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E X P E R I E N C E 7

longstandingcompetence

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tesa Labtec GmbHRaiffeisenstr. 440764 Langenfeld / GermanyTelephoe:Europe: +49 2173 9735 0USA: +1 888 479 6785Email: bd.tesa-labtec@tesa.com

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