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Oral Delivery Oct 06 18/1/07 20:19 Page 1 Oral Delivery Oct 06 18/1/07 20:19 Page 1 ORAL DRUG DELIVERY WHEN YOU FIND THE HOLY GRAIL www.ondrugdelivery.com Oral Delivery Oct 06 18/1/07 20:19 Page 2 “Oral drug delivery: when you find the Holy Grail” CONTENTS This edition is one in a series of sponsored themed publications from ONdrugDelivery Ltd. Each issue focuses on a specific topic within the field of drug delivery, and contain up to eight articles contributed Introductory comment by leaders in that field. Guy Furness 3 Full contact information appears alongside each article. Contributing companies would be delighted to hear Growing sales and new opportunities for oral from interested readers directly. ONdrugDelivery fast dissolve would also be very pleased to pass on to authors, or Dr Ian Muir answer as appropriate, any queries you might have in relation to this publication or others in the series. Cardinal Health 4-6 During 2007 ONdrugDelivery will be covering the following topics: From oral drug delivery technology to proprietary February: Transdermal delivery product development April: Pulmonary delivery Dr Anand Baichwal, Thomas Sciascia, MD June: Prefilled syringes Penwest Pharmaceuticals 7-10 August: Oral drug delivery October: Delivering injectables December: Nanotechnology in drug delivery Combination oral products: the time is now! Fred H. Miller To start a FREE subscription (pdf or print) to INNERCAP Technologies 12-15 ONdrugDelivery’s sponsored series, please contact ONdrugDelivery directly (details below) Combining technologies without compromise: taste masking + ODT + modified release Steve Ellul Eurand 16-19 Oral drug delivery: the Holy Grail To find out more about how your company can Ms Bavani Shankar participate in 2007, please contact ONdrugDelivery Emisphere Technologies 20-21 directly (details below). Contact: More than just fast-dissolve: Guy Furness, Publisher CIMA’s broad oral delivery technology offering T: +44 1273 32 02 79 Dr Richard J. Welter, Dr Derek Moe E: [email protected] CIMA R&D 22-23 Oral drug delivery: when you find the Holy Grail. Company profile Published by ONdrugDelivery Ltd, Cedar Cottage, SkyePharma 25 Newtimber Place Lane, Newtimber, West Sussex, BN6 9BU, United Kingdom. Registered in England: No 05314696. Copyright © 2007 ONdrugDelivery Ltd The views and opinions expressed in this issue are those of the authors. Due care has been used in producing this publication, but the publisher makes no claim that it is free of error. Nor does the publisher accept liability for the consequences of any decision or action taken (or not taken) as a result of any information contained in this publication. Front cover image reproduced with kind permission from InnerCap Technologies, Inc, whose article appears on page 12 of this issue 2 www.ondrugdelivery.com Copyright © 2007 ONdrugDelivery Ltd Oral Delivery Oct 06 18/1/07 20:19 Page 3 INTRODUCTION Despite phenomenal advances in the inhalable, The message that pharmaceutical companies The increasing injectable, transdermal, nasal and other routes usually send to would-be oral technology number of oral fixed- of administration, the unavoidable truth is that partners is: only those with technologies that are dose combinations oral drug delivery remains well ahead of the highly differentiated, fulfil needs that are near reaching the market and their growing acceptance pack as the preferred delivery route. There are impossible to meet elsewhere, and are proven in by the medical and regulatory communities is of course many applications and large markets the market place, need apply. highlighted by InnerCap Technologies. The for non-oral products and the technologies that company’s multiphase, compartmentalised capsule deliver them. However, if it is a viable option, Nevertheless, although the environment is technology, NovaCaps, both meets the existing oral drug delivery will be chosen in all but the tough, success is possible. Indeed, a thriving oral needs for developing oral combinations, and most exceptional circumstances. Moreover, if drug delivery sector does exist and it is expands the potential application of combinations the oral route is not immediately viable, populated by innovative companies involved in into areas not previously considered possible. pharmaceutical companies will often invest fruitful collaborations with pharma and biotech resources in making it viable, rather than partners. I will divide these successful oral drug Finally, we are pleased to include here a piece plumping for an alternative delivery method. delivery technologies into two broad categories: from Emisphere Technologies. Its eligen drug carrier technology for delivering fragile In a presentation last year, John Lynch, Chief 1. technologies which represent the crème de la macromolecules via the oral route has the Operating Officer of Merrion Pharmaceuticals crème among many available systems addressing potential to bring the Holy Grail, oral drug said that the oral drugs market generated US$26 a common delivery need (such as modified- delivery, within the reach of biologics companies billion sales in 2004 and would experience 16% release or orally disintegrating tablets) and others for whom oral delivery has growth up to 2008. He added that orally traditionally been viewed as out of the question. delivered products accounted for 84% of the sales 2. highly specialised technologies meeting a With a remarkable claim such as this, the of the top 50 selling drugs worldwide. niche demand or a need with a high company has met with scepticism and even technological barrier to entry (for example, oral derision over the years. Having made significant Oral products go from strength to strength, delivery of fragile macromolecules, or precision progress and generated robust data despite its but the oral drug delivery sector is by no means release at specific locations within the GI tract) critics, here it presents encouraging evidence that an easy one to succeed in. In fact it has to some eligen does indeed fulfil its promise. extent become a victim of this popular delivery In this issue we are delighted to present route’s success. Firstly, drug discovery efforts articles from six of the leading names in oral drug The primary purpose of this publication is to are directed at generating compounds that are delivery. It is of course up to the reader to decide provide a platform from which companies can readily orally deliverable and have the right into which, if either, of the two categories above describe their oral drug delivery systems and pharmacokinetic/pharmacodynamic profile the technologies described might fall. outline their merits using scientific data and study without the need for any specialised delivery results. However, during the process of choosing a technology. Secondly, when an oral drug Various aspects of oral drug delivery are drug delivery partner it is important not to delivery technology is needed, it is common for covered including: oral controlled-release; orally underestimate the significance of “soft factors” – pharma companies to develop them in-house. disintegrating tablets (ODTs); fixed-dose essentially the factors such as company culture, It’s worth the effort because the technology is combination capsules; oral macromolecular business practices and individual employees’ likely to be useful to them in the future since the delivery; and the move to a specialty pharma personalities, which decide whether a good day-to- majority of products in the pipeline are business model. day working relationship between two administered orally. Thirdly, the potentially organisations will be possible. This is especially large rewards of developing a successful oral Three of the articles in this issue are contributed important when considering a shortlist of similar delivery system have meant that the market is by companies discussing their ODT systems. Side technologies fulfilling similar functions. now awash with hundreds, if not thousands, of by side, these provide an insightful comparison of undifferentiated oral drug delivery companies competing technologies, and taken together the In addition to enabling those readers seeking with equally undifferentiated technologies. papers provide a detailed overview of the latest partnerships for oral drug delivery systems to developments, current issues and trends within this learn about the technologies described in terms For pharma companies requiring a third rapidly growing sub-sector of oral drug delivery. of science, specifications and compatibility with party technology to deliver their compounds, it their own needs, it is my intention that this is difficult to find the right partner. For the The contribution from Penwest publication should also allow the reader, through delivery companies hoping to enter, although Pharmaceuticals discusses the recent approval and the written word of the authors, to get to know the sheer size of the oral delivery technology launch of Opana ER and the first definitive step in the companies themselves a little in terms of market could to some extent improve the its strategy to leverage its oral drug delivery their business strategy, manner and style. chances and potential degree of success, things expertise in the transformation from a technology are significantly more difficult than they might provider to a specialty pharmaceutical company Guy Furness initially seem. focused on neurology. Publisher Copyright © 2007 ONdrugDelivery Ltd www.ondrugdelivery.com 3 Oral Delivery Oct 06 18/1/07 20:19 Page 4 GROWING SALES
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