Adderall XR Defence. Status: 9 th January 2003

Transcription

1 Adderall XR Defence Status: 9 th January 2003

2 Comment on the Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 The statements made during today s presentation, or in response to questions during the Question & Answer period, that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event that such risks or uncertainties materialise, Shire s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, including but not limited to the impact of same on Shire s ADHD franchise, patents, government regulation and approval, including but not limited to the expected approval date of lanthanum carbonate (Fosrenol/Fosnol) and other risks and uncertainties detailed from time to time in periodic reports produced by Shire, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission. Trademark Information: Unless otherwise indicated, certain product names set out in this document are trademarks of the Shire Group, many of which are the subject of trademark registrations in certain territories. These names include, but are not limited to, Adderall, Adderall XR, Agrylin, Colazide, Carbatrol, DextroStat, Dirame, Fluviral S/F, Fosrenol, Foznol, MMX, Pacis, Pentasa, ProAmatine, Solaraze, Troxatyl, EnSoTrol, Microtrol, OptiScreen, ProScreen, and Solutrol. 3TC, Epivir, Combivir, Trizivir, and Zeffix are trademarks of GlaxoSmithKline. Reminyl and Concerta are trademarks of Johnson & Johnson. Aricept is a trademark of Pfizer / Eisai. Exelon is a trademark of Novartis. NeisVac-C is a trademark of Baxter International. Adept is a trademark of ML Laboratories.

3 Introductory Comments We were informed late on that the FDA is showing on one of their websites that they have received an ANDA for a generic copy of Adderall XR. However Shire has not received a paragraph IV declaration or any other formal advice on the above. Shire has regularly maintained that it was highly likely that generic companies would submit such an ANDA attempting to receive an FDA approval. Our strategy to defend our leadership position in the US ADHD market is explained in the enclosed slides. The statements on these slides are based on information currently available to us and as currently understood. It is our intention to update this document or issue separate statements as appropriate, when important, new information becomes available.

4 Adderall versus Adderall XR Adderall* no exclusivity or patent protection in recent years no reporting requirement from a generic applicant to Shire at the time of an ANDA submission no knowledge when a competitor submitted an ANDA As the following slides explain, Adderall XR is in a totally different and stronger position! * 1997 to 2001 perspective

5 Adderall versus Adderall XR (cont.) As with Adderall, we have planned our future ADHD strategy carefully.

6 Adderall XR: Patent status Adderall XR based on paediatric indication has Hatch-Waxman exclusivity until October 2004 and Adderall XR is protected by a valid, pharmaceutical composition patent The patent extends until 2018 It will be difficult for a generic company to develop a similar product that receives AB rating that could be substituted for Adderall XR and does not infringe our patent and offers similar patient benefits including capsule presentation, sprinkle form speed of onset, duration of action and effect size

7 ANDA application for generic version of Adderall XR Once a generic company submits an ANDA: They must provide a paragraph IV certification to the FDA and supply notice to Shire if they are seeking to market before expiry of Shire s patent (2018) Shire has 45 days from the notice to decide whether to initiate legal action against the ANDA applicant for potential patent infringement It is our policy, to rigorously defend our IP While the potential legal action is pending, the FDA will not approve the ANDA. The approximate duration of such legal actions is 30 months If Shire succeeds in the infringement action, the FDA will not approve the ANDA and Shire s rights through the life of the patent remain If Shire loses, the FDA may approve the ANDA Based on 30 months litigation, currently, the earliest entry would be mid 2005.

8 snda for adult indication of Adderall XR Shire submitted on a supplementary NDA for the use of Adderall XR in adults. This submission is for specific strengths for use in adults, is supported by clinical data and is expected to attract its own 3 year Hatch-Waxman protection Subject to FDA approval and the assumption that this approval would be received by early 2004, this additional Hatch-Waxman protection would extend to early 2007.

9 Paediatric Extension Subject to the FDA and Shire agreeing an appropriate clinical trial programme for Adderall XR, Shire could receive a 6 months extension to the Hatch-Waxman protection period for its Adderall XR approvals. It is our current understanding that, if agreed with FDA, such an extension would add 6 months of protection both to the paediatric and the adult Hatch-Waxman protection periods. This would extend the Hatch-Waxman paediatric protection from October 2004 to April 2005 and for the adult indication from potentially early 2007 (subject to FDA approval) to mid 2007.