Drug Delivery Myths Dispelled

Editor’s Note: Contributions included courtesy of Vik Seoni, vice president & head of business development, and Fidelma Callanan, director of marketing & communications, Elan Drug Technologies

In a December 17th post on our blog somewhat rhetorically titled, “The View Is Great, But Is It All Down Hill From Here?” Dr. Peter Kramer of Princeton Technology Consulting offered a sobering assessment of the pharmaceutical industry’s current trajectory.

Among the bright spots, however, Kramer observed that the drug delivery innovation model – or “drug delivery thinking” as he coined it – could potentially provide “an alternative to the consolidation approach to problem-solving” now routinely applied as a band-aid to long-term pharma industry sustainability concerns.

Dr. Kramer understands all too well the power of drug delivery thinking as a blueprint for achieving enduring scientific and commercial success. Among his credentials, Kramer established and formerly directed Bristol-Myers Squibb’s Technology Transactions Group, an organization dedicated to negotiating drug delivery R&D partnerships.

Perhaps not coincidentally – and as its name suggests – the 15th annual DDP conference is devoted to this very end: mastering the art of optimizing drug delivery innovation via collaboration in order to propel pharmaceutical and medical device interests in an increasingly uncertain era.

It would therefore seem to me that as far as this audience is concerned, Dr. Kramer may have been preaching to the choir; unfortunately, one may infer from the problems Dr. Kramer identified in his post that not everyone in the pharma sphere is singing our tune.

To wit: Late last year I undertook a series of informational interviews with drug development stakeholders.

In the course of those interviews, I spoke with Elan Drug Technology’s Vik Seoni – a member of DDP’s Advisory Board – who referred me to his colleague across the pond, Fidelma Callanan, who in turn suggested that any productive conversation about the role of drug delivery in relation to the overall health and future of the biopharma industry should begin by addressing some significant, widespread misconceptions.

Fortuitously, Elan had published a whitepaper on the topic, which opened with an astute but unsettlingly blunt observation: “The drug delivery market is often viewed as the poor relation of the pharmaceutical industry.”

The abstract went on to conclude that – consistent with Dr. Kramer’s assertion – far from being “a sector on the wane, drug delivery is a vibrant source of technology-based product solutions that pharmaceutical companies would be well advised to consider as a means of bolstering their lagging product portfolios.”

For those of us who recognize the value and untapped potential of drug delivery innovation at a time when the biopharma industry appears to be in a state of flux and in need of fresh solutions to chronic problems, I offer for your consideration the following battery of five common myths and realities, courtesy of our friends at Elan Drug Technologies…

Ps. To register for the 15th Annual Drug Delivery Partnerships (DDP) conference or for more information, please visit www.iirusa.com/ddp

ABOUT THE AUTHOR
Marc Dresner is an IIR communication lead with a background in trade journalism and marketing. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com

Five Drug Delivery Industry Myths & Realities

(Source: Elan Drug Technologies)

1. Drug delivery has not delivered

Many believe that drug delivery as a method to introduce new drugs to the market has gone past its sell by date. However an analysis of the drug delivery market overall and its place within the larger pharmaceutical market paints a very different picture.

There has been a steady flow of drug delivery-based product approvals over the past decade. According to a review by Bossart, Seto and Kararli in May 2010i, 213 drug delivery products were launched in the past 10 years. With 20 approvals in 2009 for drug delivery products (17 of which were enhanced and three enabled), this compares very favorably with nine biologics (new chemical entities classed as biologics) approvals for 2009ii.

Drug delivery systems continue to play a key role in addressing the challenges faced by the pharmaceutical industry by developing and enabling better treatment options for patients and healthcare systems. Based on a recent analysis by the MedTRACKiii database, there are over 1,400 controlled-release products currently on the market. Drug delivery has indeed delivered and continues to be a very important source of products for the pharmaceutical market.

2. Drug delivery market is in decline

According to recent analysis by IMS, drug delivery-based product growth has outpaced total pharma growth over the past 10 yearsiv. In 2007 the drug delivery market accounted for 27% of total pharma sales and is expected to account for 32% by 2012, according to IMS.

Growth in technology and intensifying industry competition will lead to drug delivery systems growth as companies seek opportunities to extend the lives of their drug candidates. It is interesting to note that approximately 75% of recent drug approvals by the U.S. Food and Drug Administration (FDA)v are for new or improved formulations of existing drugs.

Changes internationally in healthcare approaches will also favor drug delivery where improving therapeutic outcomes, compliance and the reduction of the overall cost of patient treatment will be helped through the application of drug delivery solutions. Industry analysts believe that product line extensions will continue to be a key area of pharmaceutical growth.

Declining R&D productivity, increasing development costs and pending genericization of many pharmaceutical products mean that companies need to focus on having a constant flow of new products that address real patient needs and more generally the needs of healthcare systems. Pharmaceutical companies are under increasing pressure to provide value to patients and healthcare systems while maintaining and enhancing their revenues. Drug delivery

systems and the products developed incorporating them have a significant positive commercial impact within the pharmaceutical industry.

3. The drug delivery model is not sustainable

It is true that not all drug delivery companies are sustainable, and it is a market that includes many start-ups, as well as many that have struggled for years to reach profitability – similar to the biotech industry; however, it is a very active sector with over 1,000 companies classing themselves as drug delivery firms.

The top 10 drug delivery companies had combined revenue in 2009 of $6.8Bvi. Examples include Elan Drug Technologies (part of Elan Corp plc), which as a business unit has been a stellar performer with its net income increasing by

124% between 2005 and 2009 from $29 million to $65 millionvii.

Other drug delivery companies that consistently perform well include Cima Labs, Alkermes and Nektar; however, for more drug delivery companies to become and remain viable, strategic innovation is important to ensure complex and competing technology investments are aligned with emerging market needs and support their clients’ (pharma companies) goals.

4. Drug delivery-based product life cycle management strategies are not worth the bother of pursuing

There are many approaches to lifecycle manage a product; however, those pursued using drug delivery approaches have proven better than most where patient/clinical benefits are apparent.

A Cutting Edge Information reportviii found in particular that new formulations were shown to deliver one of the best returns on investment. New formulations as a strategy proved significantly more effective than pursuing an OTC switch, repositioning, seeking new indications or going the branded generic route, according to the report.

A Merrill Lynch industry reportix found that 87% of ‘switch and grow’ strategies not only sustained the value of the original franchise, but increased sales following the switch to the optimized formulation. Examples include Ritalin® LA which grew the methylphenidate franchise by 62% for Novartis over the first four quarters following launch, Xanax® XR enjoyed an increase of 34% and Fosamax® an increase of 25% in the first year post launch.

5. All drug delivery companies offer the same services

While many drug delivery companies offer controlled-release technologies – mostly for oral delivery – there are many drug delivery companies that offer a much broader range of technology solutions.

For example, central to Elan Drug Technologies’ success over the past decade, where it was seen as the top performerX, was that it had “a broad portfolio of drug delivery assets that could embrace their clients’ products.” This broad and unique platform from Elan includes technology solutions ranging from oral controlled release, delayed release, pulsatile release to technology solutions for poorly water soluble compoundsxi.

While oral drug delivery is still the most active in terms of deals signed, the market has evolved significantly over the past number of years with a variety of goals being sought beyond the more typical extended/controlled-release solutions. Companies offering targeted site delivery, pulsatile release, and bioavailability enhancement technologies are key examples.

Indeed, what has shown to be more effective than having a unique offering is having a proven range of technology solutions. A recent Bionumbers reportxii showed that a product with a validated technology has twice the chance of gaining approval as an unvalidated one.

When speed to market for a lifecycle management strategy is key, a drug delivery solution is a significantly faster way of getting approval than – for example – a new chemical entity with average time from initial development to market approval being ~5.8 years (NCE average over eight years). Considering that every six-month delay in launch results in a loss of around $100M on the NPV or a drop of 0.5 percentage points in the IRR as calculated by PriceWaterhouseCoopersxiii, having a proven technology behind the product innovation is key.

Conclusions

The pharmaceutical industry faces a significant challenge to provide genuinely improved treatment options for patients and healthcare systems that are also cost effective. New drug output continues to stagnate, while R&D costs remain high. Addressing this challenge requires that pharmaceutical companies rethink their approach to new drug discovery and development, develop improved products that address real needs and to commercialize those products. Scientific advances in our understanding of diseases, new molecules that treat those diseases and methods to best deliver those molecules for patients, continue to evolve.

For more information about Elan Drug Delivery Technologies, please visit www.elandrugtechnologies.com or e-mail edtqueries@elan.com

References

i Delivery Report – Drug Delivery Products & Technologies – a decade in review: Approved Products 2000-2009, Bossart, Seto, Kararli, Drug Delivery Technology, May 2010 Vol 10 No 4

ii The FDA New Product Approvals 2009 http://www.fiercebiotech.com/story/fda-approvals-2009/2010-01-25

iii MedTRACK presentation made by Sarah Terry, CRS Annual Meeting, Portland Oregon, July 2010

iv IMS database, 2009 report

v Sourced from FDA drug approval lists 2002-2009 from FDA database

http://www.fda.gov/drugs/informationondrugs/default.htm

vi Yahoo sector analysis http://biz.yahoo.com/ic/513.html

vii Elan Drug Technologies’ Business Review 2009, www.elandrugtechnologies.com

viii Defending brand revenue – pharmaceutical life cycle management planning – Cutting Edge Report, 2008

ix Merrill Lynch Industry Report, January 2006

x Delivery Report – Drug Delivery Products & Technologies – a decade in review: Approved Products 2000-2009, Bossart, Seto, Kararli, Drug Delivery Technology, May 2010 Vol 10 No 4

xi Elan Drug Technologies website – technology page http://www.elandrugtechnologies.com/technology

xii Parameters of Performance Series – An overview of key parameters that impact clinical development and

approval of drug delivery enabled and enhanced pharmaceutical products – Bionumbers, March 2010

xiii Pharma 2020 The Vision – which patch will you take, PWC report http://www.pwc.com/gx/en/pharma-lifesciences/pharma-2020/pharma-2020-vision-path.jhtml