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Update on Penn Pharma John Roberts, Commercial Director December 2012.

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Presentation on theme: "Update on Penn Pharma John Roberts, Commercial Director December 2012."— Presentation transcript:

1 Update on Penn Pharma John Roberts, Commercial Director December 2012

2 The Business Penn 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.

3 Core Services Pharmaceutical 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

4 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……….

5 Penn Contained Manufacturing Operations A bespoke facility dedicated to the development and manufacture of potent, oral solid dose products.

6 Potent compounds Drugs with pharmacological activity at doses of 1mg or less Cytotoxic/cytostatic/immunosuppressive drugs Teratogenic/embryotoxic drugs Carcinogenic/mutagenic drugs Certain hormones Drugs with a known or estimated OEL of ≤10µg/m 3 8h TWA

7 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.

8 Project Milestones ActivityScheduleStatus Board ApprovalQ3 2011Complete Building DesignQ3 2011Complete Planning Permission GrantedQ4 2011Complete Equipment URS definedQ4 2011Complete Enabling worksQ1 2012Complete Final equipment choiceQ1 2012Complete Equipment OrderQ1 2012Complete Facility Construction StartQ1 2012Complete Plant Installation StartQ3 2012Ongoing Commissioning & Validation StartQ4 2012Ongoing Facility / Equipment handoverQ1 2013On Target

9 Thank you

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