for your reading pleasure

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2 EDITORIAL For Your Reading Pleasure This month’s issue reflects the news coming out of two big conferences in the previous month: the annual meetings of the American Diabetes Association (ADA 2006) and the American Society of Clinical Oncology (ASCO 2006). At ADA 2006, impressive phase III results were presented for Januviaand Galvus ® , the first two members of a new class of oral drug for type 2 diabetes – the dipeptidyl peptidase (DPP)-IV inhibitors (p3). Decisions on US FDA approval are expected in October and November this year, respectively. Despite theoretical concerns regarding potential toxicity of DPP-IV inhibitors, the actual safety profiles look very good (possibly better than the glitazones), prompting market analysts to forecast sales of >$US1.5 billion by 2010 for both Januvia and Galvus. Until very recently, advanced renal cell carcinoma (RCC) has been virtually untreatable. Now late-breaking data on progression- free survival from a phase III clinical trial presented at ASCO suggest that Sutent ® should replace immunotherapy as the gold standard for initial therapy of advanced RCC (p8). And late-breaking phase III data indicate that the mTOR inhibitor temsirolimus actually prolongs the life span of patients with advanced RCC who have the worst prognosis. Continuing the ASCO focus, there are a number of items from the meeting in the R&D Highlights and Diagnostic Development sections (p14-18). For a change of pace, we profile FivePrime Therapeutics (p11), an emerging private biopharmaceutical company that hit the news recently when Boehringer Ingelheim signed a multi-million dollar, 2-year collaborative agreement for discovery of novel therapies for rheumatoid arthritis. Tracey Wright Editor Aim and Scope: Pharmaceutical & Diagnostic Innovation is a business intelligence newsletter covering the current state of technology innovation in pharmaceuticals and diagnostics. Pharmaceutical & Diagnostic Innovation provides perspectives on a wide range of issues relevant to the pharmaceutical, biotechnology and diagnostics industries today. Global Subscriptions Manager: Meher Tata, Adis International Ltd, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand. Telephone: +64 9 477 0700. E-mail: [email protected]. Editorial Office and Inquiries: Adis International Ltd, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand. Telephone: +64 9 477 0700. E-mail: [email protected] Pharmaceutical & Diagnostic Innovation (ISSN 1176-3469) is published monthly by Adis International Limited. The annual subscription rate for 2006 print and online is $US2345 and for online only is $US2315; additional subscriptions (multi-subscription rates) mailed in the same envelope are $US1270. (Further subscription information is given at the back of each issue.) Policy Statement: Although great care has been taken in compiling the content of this publication, the publisher and its servants are not responsible or in any way liable for the currency of the information, for any errors, omissions or inaccuracies, or for any consequences arising therefrom. Inclusion or exclusion of any product does not imply its use is either advocated or rejected. The use of trade names is for product identification purposes only and does not imply endorsement. Opinions expressed do not necessarily reflect the views of the Publisher or Editor. Copyright: © 2006 Adis Data Information BV. All rights reserved throughout the world and in all languages. No part of this publication may be reproduced, transmitted or stored in any form or by any means either mechanical or electronic, including photocopying, recording, or through an information storage and retrieval system, without the written permission of the copyright holder. Production: Claire Marsden Website: http://innovation.adisonline.com Editor: Tracey Wright Pharmaceutical & Diagnostic Innovation 2006; Vol. 4, No. 7

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EDITORIAL

For Your Reading Pleasure This month’s issue reflects the news coming out of two big conferences in the previous month: the annual meetings of theAmerican Diabetes Association (ADA 2006) and the American Society of Clinical Oncology (ASCO 2006).

At ADA 2006, impressive phase III results were presented for Januvia™ and Galvus®, the first two members of a new class oforal drug for type 2 diabetes – the dipeptidyl peptidase (DPP)-IV inhibitors (p3). Decisions on US FDA approval are expected inOctober and November this year, respectively. Despite theoretical concerns regarding potential toxicity of DPP-IV inhibitors, theactual safety profiles look very good (possibly better than the glitazones), prompting market analysts to forecast sales of>$US1.5 billion by 2010 for both Januvia and Galvus.

Until very recently, advanced renal cell carcinoma (RCC) has been virtually untreatable. Now late-breaking data on progression-free survival from a phase III clinical trial presented at ASCO suggest that Sutent® should replace immunotherapy as the goldstandard for initial therapy of advanced RCC (p8). And late-breaking phase III data indicate that the mTOR inhibitor temsirolimusactually prolongs the life span of patients with advanced RCC who have the worst prognosis. Continuing the ASCO focus, thereare a number of items from the meeting in the R&D Highlights and Diagnostic Development sections (p14-18).

For a change of pace, we profile FivePrime Therapeutics (p11), an emerging private biopharmaceutical company that hit the newsrecently when Boehringer Ingelheim signed a multi-million dollar, 2-year collaborative agreement for discovery of novel therapiesfor rheumatoid arthritis.

Tracey Wright

Editor

Aim and Scope: Pharmaceutical & Diagnostic Innovation is a business intelligence newsletter covering the current state of technology innovation in pharmaceuticals and diagnostics. Pharmaceutical & Diagnostic Innovation provides perspectives on a wide range of issues relevant to the pharmaceutical, biotechnology and diagnostics industries today.

Global Subscriptions Manager: Meher Tata, Adis International Ltd, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand.Telephone: +64 9 477 0700. E-mail: [email protected].

Editorial Office and Inquiries: Adis International Ltd, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand. Telephone: +64 9 477 0700. E-mail: [email protected]

Pharmaceutical & Diagnostic Innovation (ISSN 1176-3469) is published monthly by Adis International Limited. The annual subscription rate for 2006 print and online is $US2345 and for online only is $US2315; additional subscriptions (multi-subscription rates) mailed in the same envelope are $US1270. (Further subscription information is given at the back of each issue.)

Policy Statement: Although great care has been taken in compiling the content of this publication, the publisher and its servants are not responsible or in any way liable for the currency of the information, for any errors, omissions or inaccuracies, or for any consequences arising therefrom. Inclusion or exclusion of any product does not imply its use is either advocated or rejected. The use of trade names is for product identification purposes only and does not imply endorsement. Opinions expressed do not necessarily reflect the views of the Publisher or Editor.

Copyright: © 2006 Adis Data Information BV. All rights reserved throughout the world and in all languages. No part of this publication may be reproduced, transmitted or stored in any form or by any means either mechanical or electronic, including photocopying, recording, or through an information storage and retrieval system, without the written permission of the copyright holder.

Production: Claire Marsden

Website: http://innovation.adisonline.com

Editor: Tracey Wright

Pharmaceutical & Diagnostic Innovation 2006; Vol. 4, No. 7