ANDOVER, UK – (4 October, 2000) – Shire Pharmaceuticals Group plc (LSE : SHP.L, Nasdaq : SHPGY) announces that a New Drug Application (NDA) for SLI 381, the novel once-a-day formulation of Adderall for Attention Deficit Hyperactivity Disorder (ADHD) was delivered to the US Food and Drug Administration (FDA) yesterday.
Once-a-day Adderall utilises the Microtrol technology of Shire's advanced drug delivery company, Shire Laboratories Inc., which is similar to that already applied to Carbatrol®, a product Shire markets successfully in the US for the treatment of epilepsy and trigeminal neuralgia.
Rolf Stahel, Chief Executive of Shire, commented, "We are delighted with the strong profile as well as the expeditious development of this project, which has been completed ahead of schedule. The project represents a key part of our ADHD strategy and together with the two further ADHD projects in development aims to build upon the tremendous success of Adderall."
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Notes to editors
Shire Pharmaceuticals Group plc
Shire is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The group has a sales and marketing infrastructure with a broad portfolio of products targeting with its own sales force the US, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004. Shire intends to cover other significant pharmaceutical markets indirectly through distributors. We have already appointed distributors in Australia, Denmark, Finland, Hong Kong, Israel, Malaysia, Norway, Philippines (limited to one third party product licensed to the local distributor), Singapore, South Africa, South Korea, and Thailand.
Shire's global search and development expertise has to date successfully provided eight marketed products, of which Reminyl for the treatment of Alzheimer's disease is the latest to be launched in its first market, the UK. The current pipeline of 15 projects includes Reminyl in registration in the US and various other markets and 9 others that are post Phase II. Shire is actively seeking to acquire further marketed products and development projects to enhance the potential for future growth. Shire M&A activity has resulted in five mergers and acquisitions during the last six years.
Shire's focus and outsourcing policies have resulted in sales per employee of $400,0001, one of the highest ratios in the Pharmaceutical Industry.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties, including but not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, patents, and other risks and uncertainties, including those detailed from time to time in periodic reports, including the F-4 Prospectus and the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission.
1.Based on 1999 figures