Formation of US affiliate

16 July 2010

Website News

Weybridge, Surrey, UK - Special Products Limited, the speciality pharma company focused on niche therapeutic areas, announces the formation of a US affiliate company that will seek US marketing approval for some of the company’s key products. The name of the new company will be revealed after the trademark applications and incorporation of the entity are complete.

After a detailed analysis of the North American market, Special Products has identified substantial commercial opportunities for up to 12 of its products in the US, the world’s largest pharmaceutical market. The new US company will seek Food & Drug Administration (FDA) approval of these products. The first application for drug approval will be filed with the FDA by the second half of 2011.

Michelle Welborn, PharmD has been appointed the Chief Executive Officer (CEO) and John Warner, JD, MPA has been appointed the Chief Regulatory Officer (CRO) of the US corporation, which will be based in Winston-Salem, North Carolina.

Michelle has significant experience of the US pharmaceutical industry gained at major companies including Sanofi-Aventis and Astra-Merck and in smaller and non-profit organizations. In addition to general management and business development, she has worked extensively in medical and regulatory affairs and has particular expertise in orphan drugs and rare diseases.

In more than 30 years in the pharmaceutical industry, John has gained extensive experience of pharmaceutical regulation. He has prepared a wide variety of FDA submissions and represented companies in numerous meetings with the FDA . He also has expertise in clinical trial management, the formulation of medicines and pharmaceutical manufacturing.

Special Products’ Chairman, Graham March, commented: "We believe that some of our products could meet significant unmet patient needs in the US thereby bringing a substantial commercial opportunity to Special Products. Having taken the first step of creating a US company we now look forward to advancing some of our products through the US regulatory system and making those products available to patients."

For further information:

US Subsidiary - Email: USinfo@specialproducts.biz Michelle Welborn, CEO
John Warner, CRO


Special Products Limited - Tel: +44 (0) 1932 690325 Graham March, Chairman
Anthony Clayden, CFO


For media enquiries please contact:
Buchanan Communications - Tel: +44 (0) 20 7466 5000
Mark Court / Katharine Sutton


Notes for editors:

Special Products Limited
Special Products Limited is a UK speciality pharmaceutical company focused on the development and distribution of medicines for patients with rare disorders and unmet medical needs. Our core skill is in the development of long shelf-life special products, which we distribute from our headquarters in Weybridge, Surrey, throughout the UK and into export markets. For further information, please visit: www.specialproducts.biz.