Update on Penn Pharma

John Roberts, Commercial Director

December 2012

The BusinessPenn provides an integrated range of services to an international client base. Pharmaceutical Development Manufacturing & Packing Support Services

Headquartered in South Wales since 1986, with 300+ staff (>95% local) on 2 sites.

Trading for over 30 years, Penn is approved by MHRA (UK) and FDA (USA)

Recognised for its export experience, Penn supplies EU, USA, Japanese, Australia and South American markets (Queen’s Award Winners 1993 and 2010)

£30m turnover with objective to double in next 4 years.

Core ServicesPharmaceutical Development Formulation Development Analytical Development Clinical Supplies

Manufacture & Packing Solid Oral Dose Creams/Ointments/Gels Oral Liquids Clinical Trial Batches High Containment Controlled drugs

Support Services QP Services Storage & Distribution EU Portal Importation & Distribution

Penn & Welsh Government Support

Established in Penn, Bucks in 1979 and relocated to South Wales in 1986 with WDA support.Received consistent export marketing support from WDA, IBW, and more recently WG (e.g. overseas visits, exhibitions, trade missions).Substantial support for training and development in technical and management skills - Workforce Development Scheme, Skills for Growth Scheme etc.Most recently, WG provided a capital grant to help fund important further expansion and job creation, as part of a £14m total investment……….

Penn Contained Manufacturing Operations

A bespoke facility dedicated to the development and manufacture of potent, oral solid dose products.

Potent compounds

Drugs with pharmacological activity at doses of 1mg or lessCytotoxic/cytostatic/immunosuppressive drugsTeratogenic/embryotoxic drugsCarcinogenic/mutagenic drugsCertain hormonesDrugs with a known or estimated OEL of ≤10µg/m3 8h TWA

Business Case for Investment

For many years Penn has successfully developed and manufactured ‘potent’ products requiring the use of ‘contained operations’ to protect both employees and customers.The number of ‘potent’ compounds requiring oral solid dosage form development and subsequent manufacture at the clinical and commercial scale is increasing, esp. in oncology .More than 1500 potent compounds in development by the pharma industry.Shortage of suitable state-of-the art facilities worldwide.Increasing outsourcing of development and manufacturing, esp. of potent compounds.Consequently we have decided to invest in a new facility to manufacture oral solid dosage forms within contained operations.

Project MilestonesActivity Schedule Status

Board Approval Q3 2011 Complete

Building Design Q3 2011 Complete

Planning Permission Granted Q4 2011 Complete

Equipment URS defined Q4 2011 Complete

Enabling works Q1 2012 Complete

Final equipment choice Q1 2012 Complete

Equipment Order Q1 2012 Complete

Facility Construction Start Q1 2012 Complete

Plant Installation Start Q3 2012 Ongoing

Commissioning & Validation Start Q4 2012 Ongoing

Facility / Equipment handover Q1 2013 On Target

Thank you