Partner with the Global Leader in Drug Delivery Systems

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1 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Loughborough, United Kingdom Manufacturing Facility Experts at Commercializing Innovation

2 3M: Transforming New Ideas into Thousands of Ingenious Products 3M is a global innovation company that never stops inventing. Over the years, our innovations have improved daily life for hundreds of millions of people and businesses all over the world. Every day at 3M, one idea always leads to the next, igniting momentum to make progress possible around the world. On average, every person will come into contact with a 3M product or technology 17 times a day. Electronics & Energy Industrial Consumer Health Care Safety & Graphics Innovation on a Global Scale With subsidiaries in more than 70 countries and operations in nearly 200 countries, 3M is truly a global company. Currently, 3M offers more than 60,000 products which generate sales in excess of US$ 30 billion. And with almost 90,000 employees worldwide, 3M has local presence across its global markets. 3M has five global business groups, one of which is Health Care. Ingenious Solutions Transforming Health With a depth of diverse technologies, a culture of collaboration and a global footprint, 3M Health Care is a leader in delivering innovative solutions. As the creators of the metered dose inhaler, the Drug Delivery Systems division has a proven history of drug delivery. At 3M Health Care and 3M Drug Delivery Systems, our innovations help improve the quality, cost and outcomes of care.

3 Drug Delivery Systems: It s in the detail As a pioneer in the development of intuitive, patient-friendly technology, 3M understands how to deliver life saving medication. From development to commercial scale manufacturing, we have over 50 years of knowledge and innovation that goes into everything we do. You can t always see our innovation, but look again, because it is there in the detail. Inhalation Reducing the risk of commercializing innovation Transdermal Optimize delivery and increase patient comfort Microneedle Increasing commercial success with patientfriendly solutions Having created the first metered dose inhaler (MDI) over 50 years ago, 3M has the experience and expertise to help commercialize your product. We offer MDIs with the 3M Integrated Dose by Dose Counters, a full range of inhaler components, and provide both pressureand cold-fill contract manufacturing. A transdermal form of your drug can help to differentiate your product while offering patients a more comfortable, convenient and effective way to receive their medications. 3M Microstructured Transdermal Systems (MTS) offer patient-friendly solid and hollow microneedle technology. By offering patients the efficiency of a syringe with the comfort and convenience of a patch, these technologies can help increase the commercial success of your product. Oral & Topical A partner you can trust, quality you can count on Worldwide Manufacturing Facilities Capabilities 3M is your low-risk contract manufacturing partner for a broad range of oral and topical dosage forms, offering security, service and sound value with end-to-end solutions you can trust. Inhalation Cold-fill Inhalation Pressure-fill St. Paul, MN Northridge, CA Loughborough, UK Hurlingham, AR Transdermal Nasal Gain an edge in your nasal market Oral/Topical Pilot scale Featuring no-drip aerosol delivery, 3M Nasal MDI technology is ideal for partners wanting a rapid, cost-effective extension of their inhaled product and for those seeking a device edge for new nasal treatments. Small scale Intermediate scale Large, commercial scale ISO-7 certified DEA CII-CIV compliant Packaging Films Clinical supply manufacturing Reliable packaging delivers confidence Toxicology supply manufacturing 3M Scotchpak Packaging Films can withstand every part of the product lifecycle delivering a high level of confidence, even for the most challenging applications. Inspections FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR, INVIMA

4 3M Loughborough, United Kingdom: Local Knowledge, Global Resources With long-standing expertise in inhalation, oral and topical drug delivery, 3M Loughborough offers a dedicated local team backed by a truly global support network. Our culture of continuous improvement, customer focus and the ability to handle complex problems have made us a global centre for the manufacture of inhalation, oral and topical products. Our responsive local team can help you reduce the risk of commercializing your next oral, topical or inhaled product. With state-of-the-art cgmp compliant manufacturing including cold-fill capabilities as well as flexible options for capsules, tablets, creams and gels we are ready to become your trusted partner. Technical Expertise to Get You to Market Faster Our team has the experience, capacity, and extensive quality and regulatory expertise to support our customers through every step of the product commercialization process: Screening one or more compounds for compatibility with one of our drug delivery technologies. Evaluating formulation, process and component variables in the feasibility phase to ensure smooth product development and commercial scale-up. cgmp contract manufacturing capabilities offering flexible batch sizes to support market needs. Regulatory support with a proven track record including six single-cycle FDA reviews in six years. Local presence, with a deep understanding of the unique culture and regulatory processes in the region. A global leader in oral and topical drug delivery, we have the experience to maximize the potential of your formulation. At 3M Loughborough, we are experts at commercializing innovation. Post launch technical support for regulatory changes, line extensions, and product updates. Laboratory Pilot Facility Commercial Facility Formulation Development Early Phase Development Full Development Commercial Supply Assess feasibility of delivering API through solubility, compatibility and prototype system pharma performance Refine the system for optimum performance, product toxicology and early clinical supplies Finalize design Complete method validation Scale up process Produce late-stage clinical supplies Complete registration stability Submit regulatory dossier Produce validation & launch supplies Post launch technical support

5 High Quality Production and Reliable Supply 3M understands oral, topical and metered dose inhaler (MDI) manufacturing from start to finish. We ask better questions and use Lean Six Sigma processes to get you ready for market faster. For topical delivery, we can handle a wide range of viscosities with packing in aluminum or plastic tubes. We also offer delivery via large and small sachets. This convenient form allows for dosing in small quantities as low as 0.25g. For oral capsules we offer a wide variety of options including controlled release formulations, aqueous and solvent coating, powder/bead encapsulation and extrusion and spheronisation for beads. For oral tablets we offer fluid bed and tray drying, tablet compression and multiple compression suites. For MDI, we offer cold-fill capabilities, nasal inhalers and dose by dose counters. Whether it s oral, topical or MDI, we can handle any size project from clinical to commercial supply. MDI Cold-fill capabilities Powder handling technologies and custom micronization Small to large batch, commercial scale facilities Globally-compliant facilities that are always audit ready ORAL & TOPICAL Creams, gels, liquids, beads, capsules and tablets Oral, topical, buccal and sublingual Instant and controlled release formulations Pumps, blisters, bottles, sachets and tubes Automated and semi-automated packaging options High-toxicity API handling capabilities We are experts at commercializing innovation. So with our proven technical, regulatory and production experience, you can proceed with total confidence. Certifications: ISO 9001 (2008) ISO (2003) FDA approved (US) MHRA approved (EU) Registrations in over 60 countries

6 3M Loughborough Capabilities, Services and Quality Control Inhalation Drug Delivery Cold filling manufacturing capabilities Potent compound handling and size reduction Clean in place (CIP) systems for quick cleanings and changeovers Concentrate preparation vessels with low or high shear mixing Batch formulation vessels with in-tank agitation and continuous recirculation to fill table Isolator technologies used in sampling and formulation of hazardous materials Oral Drug Delivery (Capsules) Extrusion & spheronisation for beads Aqueous and solvent coating Powder/bead encapsulation Controlled release formulations Oral Drug Delivery (Tablets) Multiple granulation suites Fluid bed and tray drying Tablet compression Topical Drug Delivery Accurate dosing of small fill weights Wide range of viscosities Large and small sachets Aluminium & plastic tubes Pump filling Liquids Manufacturing 4500 litre manufacturing plant Integrated bottle packaging line Plastic and glass bottles Packaging Fully segregated & flexible GMP facilities Full range of packaging techniques Blister/bottle packaging for tablets and capsules Cream sachet and powder sachet filling Liquid bottle filling Packing capability for tubes Pump filling Automated/semi-automated packaging solutions Plant Analytical Laboratory Physical-chemical laboratory Stability chambers (25C/60RH; 40C) Spectrophotometers (FTIR, UV-VIS, Hand-Held NIR) Compendia testing Full micro laboratory Quality Assurance World Class Pharmaceutical Global Quality Systems Implemented (Q10) Finished product complete release Lean Six Sigma Change Management Deviations and Quality Incidents Management Corrective And Preventive Actions (CAPAs) Annual Product Review Supply Chain Capabilities Validation inventory management system for warehouse and materials management Temperature-controlled warehouse (<25 C/<77ºF) Flammable products warehouse Use of heat-treated wooden pallets Established S&OP (Sales & Operations Planning) process In-house Packaging Engineering Team Site wide Lean Management System implementation

7 From Start to Finish, 3M is the Right Partner for All Your Manufacturing Needs: 3M is a stable company to select for your product supply 3M has the global capability for development and commercial manufacturing 3M has a commitment to quality and continuous improvement Business Card 3M has over five decades of proven success in drug development, manufacture and delivery to market. Contact us at 3M.com/DDS to receive an initial, cost-free paper feasibility assessment and to begin partnering with us to commercialize your innovation.

8 About 3M Loughborough This 18-acre site opened in M Loughborough has facilities for manufacturing, supply chain management and distribution and R&D. We specialize in contract manufacturing of oral, topical and inhalation drug delivery systems. 3M House Morley Street Loughborough, Leicestershire LE11 1EP England (44) Fax (44) M.com/DDS Additional Facilities 3M Argentina Los Arboles 842, Hurlingham (1686) Buenos Aires, Argentina (54) M.com/DDS 3M Northridge Nordhoff Street Northridge, CA USA (1) Fax (1) M.com/DDS 3M Center Building E-10 St. Paul, MN USA (1) Fax (1) M.com/DDS 3M and Scotchpak are trademarks of 3M Company. 3M All Rights Reserved Experts at Commercializing Innovation