1. Page Break 2 + Strap line

2. About Quay Pharma Provider of contract development and manufacturing services to the pharmaceutical and healthcare industries Based in the United Kingdom Founded in 2002 Global client reach Privately owned, financially secure

3. Quay People Quay has 50+ employees, with majority dedicated to supporting customer projects Cross functional formulation development, analytical, QC and manufacturing team Flexibility Responsiveness Dedicated project managers to deliver client projects

4. Professor Mike Rubenstein (Founder and Chairman) Over 40 years experience in solid dosage form design, development and manufacture Chemical engineer and pharmacist with QP status Industrial background in R&D and production at GSK and AZ Prof. of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at LJMU Author of five books and over 200 original research papers in Pharmaceutical Technology in solid dosage development and controlled drug delivery Professor John Collett (Chief Scientific Officer) Professor at The University of Manchester World authority on polymeric drug delivery with over 30 years formulation science experience Author of over 250 research papers Specialist areas of expertise include; formulation of solubilised systems development of modified release drug delivery systems improving oral bioavailability of poorly water soluble drugs

5. How we can help Solving complex drug development challenges Overcoming challenging physiochemical properties of APIs Improving performance of existing products Providing safe, robust products for clinical trials Manufacturing services for wide range of dosage forms Effective management of client’s projects

6. Quay Services

7. Expertise with broad range of dosage forms tabletscapsulesmultiparticulates topicalsoral liquidsparenterals

8. Drug Delivery Expertise Modified release tablets Multi-particulate technologies Modified release microparticles Semi-solids in capsules Coating technologies Permeation enhancing technologies

9. Multi-faceted approach to solving solubility and bioavailability challenges lipophilic systems solid dispersion systems micro- environmental pH control particle size optimisation solubilisation

10. Renowned Analytical Services Quay has excellent track record in developing robust analytical methods for wide range of compounds Method development and transfer Forced degradation studies Formulation development support Stability studies QC testing

11. Manufacturing Expertise GMP manufacture of broad range of non-sterile dosage forms First in Man studies including Xcelolab TM API in vial/bottle for reconstitution Phase I/II clinical manufacturing Small scale Phase III manufacturing Specials Manufacturing Potents / Cytotoxics

12. Reliable Supply of Products for Clinic or Market Bulk packing of tablets or capsules Small scale blister packing Individual patient packs Global distribution of clinical supplies

13. Regulatory Status Manufacturer’s Authorisation for Investigational Medicinal Products (IMPs) potents cytotoxics controlled drugs Specials (unlicensed medicines) manufacturing licence Regular audits by clients and the UK regulatory authority (MHRA) Registered as a manufacturing site with the FDA

14. CASE STUDIES

15. CASE STUDY 1: Bioavailability Enhancement Using Lipidic Systems CLIENT: KuDos/AstraZeneca THE BRIEF: Oncology Treatment (PARP inhibitor) Poor aqueous solubility Bioavailability enhancement needed to progress drug OUR SOLUTION: Solubility screening and optimisation Two lipid based formulations developed Dog PK study performed Dosages subsequently reduced Drug licensed to AZ and in Phase III

16. CASE STUDY 2: Flexible Targeted Delivery System CLIENT: German Pharma Company THE BRIEF: New indication for existing product 3 Phase delivery required Immediate release in stomach (IR) Delayed release in small intestine (DR) Modified release in small intestine (MR) Flexible dosing required OUR SOLUTION: Mini-tablet system developed(<0.3mm) Central core with 3 different coating options Low cost option with scalability Ideal for rapid clinical evaluation

17. CASE STUDY 3: Bioavailability Enhancement Using Lipidic Systems CLIENT: Idenix – now licensed to GSK THE BRIEF: Anti-infective Poor aqueous solubility & bioavailability Limited funds for development OUR SOLUTION: Range of options explored Lipidic system Micronised API (dry powder) Solid suspension improved bioavailability no intra-patient variability Drug progressed to Phase I, IIa and IIb

18. CASE STUDY 4: Novel Drug Delivery System for HIV Prevention CLIENT: NYBC/Gates Foundation THE BRIEF: Intra vaginal administration Fast acting microbicide Low cost treatment required Non-irritating to vaginal mucosa OUR SOLUTION: Vaginal pessary developed Rapid gel formation (under 2 minutes) Mucoadhesive properties Exceeded client requirements IP developed and patents filed by client

19. CASE STUDY 5: Compaction Simulation to Overcome Manufacturing Problems CLIENT: Actavis THE BRIEF: Anaemia treatment Tablet product Unable to meet specification after moving production process OUR SOLUTION: Compaction simulation used to compare processes Various parameters evaluated: punch dimensions, compression force, dwell time and press speed Advised client on new tooling required Product successfully transferred

20. CASE STUDY 6: CLIENT: MediWound THE BRIEF: Non traumatic to patient Gel to provide delivery of microspheres over 48 hours Be gas permeable and not hermetically seal the wound Be terminally sterilised OUR SOLUTION (– Still in development) Thermally reversible gel Multiple combination polymer system for Content uniformity Maintain negative charge on beads We are currently understanding the requirement to cope with varying levels of exudate in wounds Release of beads to from gel over 7 hours. Using a Franz cell assessment

21. The Quay Advantage Client focused Scientific expertise Non-IP technologies Flexibility Problem solving ability Tailored approach

22. Title Slide