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Past Issue:
ORAL DRUG DELIVERY
WHEN YOU FIND THE HOLY GRAIL

CONTENTS:
Introductory comment
Guy Furness

Growing sales & new opportunities for oral
fast dissolve

Dr Ian Muir
Cardinal Health

From oral drug delivery technology to proprietary product development
Dr Anand Baichwal, Thomas Sciascia, MD
Penwest Pharmaceuticals

Combination oral products: the time is now!
Fred H. Miller
INNERCAP Technologies

Combining technologies without compromise: taste masking + ODT + modified release
Steve Ellul
Eurand

Oral drug delivery: the Holy Grail
Ms Bavani Shankar
Emisphere Technologies

More than just fast-dissolve: CIMA's broad oral delivery technology offering
Dr Richard J. Welter, Dr Derek Moe
CIMA R&D

Company Profile:
SkyePharma

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INTRODUCTION

Despite phenomenal advances in the inhalable, injectable, transdermal, nasal and other routes of administration, the unavoidable truth is that oral drug delivery remains well ahead of the pack as the preferred delivery route. There are of course many applications and large markets for non-oral products and the technologies that deliver them. However, if it is a viable option, oral drug delivery will be chosen in all but the most exceptional circumstances. Moreover, if the oral route is not immediately viable, pharmaceutical companies will often invest resources in making it viable, rather than plumping for an alternative delivery method.

In a presentation last year, John Lynch, Chief Operating Officer of Merrion Pharmaceuticals said that the oral drugs market generated US$26 billion sales in 2004 and would experience 16% growth up to 2008. He added that orally delivered products accounted for 84% of the sales of the top 50 selling drugs worldwide.

Oral products go from strength to strength, but the oral drug delivery sector is by no means an easy one to succeed in. In fact it has to some extent become a victim of this popular delivery route’s success. Firstly, drug discovery efforts are directed at generating compounds that are readily orally deliverable and have the right pharmacokinetic/pharmacodynamic profile without the need for any specialised delivery technology. Secondly, when an oral drug delivery technology is needed, it is common for pharma companies to develop them in-house. It’s worth the effort because the technology is likely to be useful to them in the future since the majority of products in the pipeline are administered orally. Thirdly, the potentially large rewards of developing a successful oral delivery system have meant that the market is now awash with hundreds, if not thousands, of undifferentiated oral drug delivery companies with equally undifferentiated technologies.

For pharma companies requiring a third party technology to deliver their compounds, it is difficult to find the right partner. For the delivery companies hoping to enter, although the sheer size of the oral delivery technology market could to some extent improve the chances and potential degree of success, things are significantly more difficult than they might initially seem.

The message that pharmaceutical companies usually send to would-be oral technology partners is: only those with technologies that are highly differentiated, fulfil needs that are near impossible to meet elsewhere, and are proven in the market place, need apply.

Nevertheless, although the environment is tough, success is possible. Indeed, a thriving oral drug delivery sector does exist and it is populated by innovative companies involved in fruitful collaborations with pharma and biotech partners. I will divide these successful oral drug delivery technologies into two broad categories:

1. technologies which represent the crème de la crème among many available systems addressing a common delivery need (such as modified- release or orally disintegrating tablets) 2. highly specialised technologies meeting a niche demand or a need with a high technological barrier to entry (for example, oral delivery of fragile macromolecules, or precision release at specific locations within the GI tract) In this issue we are delighted to present articles from six of the leading names in oral drug delivery. It is of course up to the reader to decide into which, if either, of the two categories above the technologies described might fall.

Various aspects of oral drug delivery are covered including: oral controlled-release; orally disintegrating tablets (ODTs); fixed-dose combination capsules; oral macromolecular delivery; and the move to a specialty pharma business model.

Three of the articles in this issue are contributed by companies discussing their ODT systems. Side by side, these provide an insightful comparison of competing technologies, and taken together the papers provide a detailed overview of the latest developments, current issues and trends within this rapidly growing sub-sector of oral drug delivery.

The contribution from Penwest Pharmaceuticals discusses the recent approval and launch of Opana ER and the first definitive step in its strategy to leverage its oral drug delivery expertise in the transformation from a technology provider to a specialty pharmaceutical company focused on neurology.

The increasing number of oral fixed- dose combinations reaching the market and their growing acceptance by the medical and regulatory communities is highlighted by InnerCap Technologies. The company’s multiphase, compartmentalised capsule technology, NovaCaps, both meets the existing needs for developing oral combinations, and expands the potential application of combinations into areas not previously considered possible.

Finally, we are pleased to include here a piece from Emisphere Technologies. Its eligen drug carrier technology for delivering fragile macromolecules via the oral route has the potential to bring the Holy Grail, oral drug delivery, within the reach of biologics companies and others for whom oral delivery has traditionally been viewed as out of the question. With a remarkable claim such as this, the company has met with scepticism and even derision over the years. Having made significant progress and generated robust data despite its critics, here it presents encouraging evidence that eligen does indeed fulfil its promise.

The primary purpose of this publication is to provide a platform from which companies can describe their oral drug delivery systems and outline their merits using scientific data and study results. However, during the process of choosing a drug delivery partner it is important not to underestimate the significance of “soft factors” – essentially the factors such as company culture, business practices and individual employees’ personalities, which decide whether a good day-today working relationship between two organisations will be possible. This is especially important when considering a shortlist of similar technologies fulfilling similar functions.

In addition to enabling those readers seeking partnerships for oral drug delivery systems to learn about the technologies described in terms of science, specifications and compatibility with their own needs, it is my intention that this publication should also allow the reader, through the written word of the authors, to get to know the companies themselves a little in terms of their business strategy, manner and style.

Guy Furness
Publisher

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