Pharmaceutical companies are awakening to the fact that being first in market and first in class is no longer enough. While most agree that the blockbuster approach is all but dead, there is considerable debate about its successor. “Big pharma” continues to invest record amounts in drug discovery research, but what can they learn from specialty pharma, drug delivery devices companies, and even the generics industry? A select group of thought leaders from pharma, biopharma, device manufacturers, payers, providers, and policymakers met recently at an industry forum event sponsored by Cambridge Consultants to address these issues and answer the question: “What will the shape of the drug delivery landscape look like ten years from now and what drivers would create this change?”
Big pharma buying into generics
The wave of blockbuster drug patent expiries over the next five years presents an estimated $140 billion opportunity for generics by 2016. Big pharma cannot ignore this threat to their balance sheet, and will likely stem this loss by introducing their own branded generic products. Sandoz, the generic pharmaceuticals division of Novartis, already achieved about $7.6 billion in net sales in 2008, and other companies are also moving fast. Sanofi bought Zentiva for $2.6 billion in 2008; and are investing in generics companies in India (Piramal) and Brazil (Medley). Greenstone, Pfizer’s generics arm, has inked a deal with Indian generics maker Aurobindo Pharma to sell 39 generic oral drugs in the US market and 31 for Europe. In December 2008, Merck created the BioVentures group to target the generics market.
A smarter way to differentiate
Companies are also looking to reformulation as a way to protect their drug licenses. Formulations that require weekly or monthly dosing instead of daily dosing increase convenience, even if they require new drug delivery devices. Biogen Idec and Bayer Schering Pharma have dominated the multiple sclerosis space with drugs like Tysabri and Betaseron. When Tysabri was launched, it was given by intravenous infusion. Administration was made more convenient with the introduction of prefilled syringes that eliminated mixing steps. TEVA, the world’s largest generics manufacturers entered with Copaxone, a branded product administered with a simple auto-injector. In a longer term strategic move, Novartis aims to gain a foothold with Extavia, Betaseron for injection licensed from Bayer Schering Pharma, before launching FTY720 (fingolimod), an oral formulation, a game-changing offering in this competitive space. Stronger competition is expected to drive differentiation, whether through formulation, or by offering additional benefits, such as expanding functionality in the therapeutic regime. There are signs that pharma companies will incorporate more advanced technology into their delivery devices as they strive to stand out in crowded spaces.
Local delivery
It is unlikely that local drug delivery technology will advance much by 2020. Existing devices perform well and only incremental improvement is expected over the next ten years, perhaps based on advances in materials science. However, a potential disruptor would be the arrival of more acceptable drug delivery formats, for example, a move towards tablet forms of therapy from inhalation, patch, or injection devices. Another disruptive technology would be the advent of curative therapies, perhaps based on biological molecules, which in themselves will require sophisticated delivery technology. Curative therapies would cause Big Pharma to reevaluate its business model, as they are more likely to be of shorter therapy duration, making today’s chronic treatment regimes obsolete.
Surgical delivery of drugs through drug-elution technology occupies a high-value niche. The drug cost may be only a small fraction of the cost of therapy. With drug-eluting stents, for example, this may be less than 20% of the cost of the surgical procedure. Such applications may remain niche in 2020 as payers and providers focus on outcome versus the cost of the surgical procedure needed to locally implant the device.
Systemic delivery
Systemic delivery sets high demands on the delivery technology to target the dose and reduce side effects. If possible, new formulations are targeted at oral delivery with simple tablets, or controlled-release tablets that reduce dosing frequency. However, the rise of biological formulations poses fundamental problems with this approach as such molecules are degraded in the stomach. Transdermal and intradermal delivery may circumvent the issue, but the advanced technology required to open the skin to such large therapeutic molecules is still in a relatively early stage of development.
Formulation can help to mitigate systemic impact, and some opportunities are thought to exist where formulation and device development are progressing hand-in-hand. In the case of the Glide Pharma (Oxford, UK) Glide-SDI, solid doses of the drug are injected via a reusable actuator eliminating the use of needles. Where injection delivery is used, optimizing compliance and comfort is the key driver. It is anticipated that micro-electronics will add some significant value to such devices by offering dose reminders, dose recording, and compliance monitoring. An example of this is EasyPod, where a sophisticated device has had a significant impact in the human growth hormone market, improving acceptance, compliance and market share for Merck Serono (Geneva, Switzerland). Incorporating these advanced delivery devices are not without challenge.
The development of such complex devices often requires the engagement of a multi-disciplinary team to incorporate electronics, electromechanical systems and user interface. This is a skill set that is not often found within traditional pharmaceutical companies as quality systems are based on the drug development cycle, not electromechanical or mechanical drug delivery devices. This explains why most advances in this area have come from start-ups and specialist service providers.
Over the next ten years, we will see more examples of systemic drug delivery products that offer expanded features, such as diagnostics and compliance monitoring to improve the patient outcome. To be successful, pharma companies will have to adjust their approach, developing the delivery device in parallel with the drug, rather than during Phase 3 clinical trials as often done today. The economics of developing a delivery device earlier, when the risk of the molecule failing to meet clinical goals is high, encourages pharma to hedge their bets by developing platform delivery methods that can be used for multiple pipeline products.
Trends and opportunities
In recent years, pharma companies have changed the way they view patients, thinking of them more as health care consumers to be targeted directly. This means drug delivery devices are likely to include the qualities and features associated with consumer products.
Much more emphasis is being placed on the usability, look, feel, and functionality of these “consumer drug delivery products.” Pharmaceutical companies are beginning to recognize the value of human factors engineering studies that improve their intuitiveness and ease of use. Combining ease of use with other features that increase patient compliance should improve patient outcome, and outcome-based therapy is likely to be the new battleground of the future.
Future generations of drug delivery devices are likely to include electronic dose monitoring and tracking systems. Wireless dose tracking systems enable pharmaceutical companies conducting clinical trials to monitor when the drug delivery device is used and how effective the medication is versus outcomes. The consumer can have their own product where they can monitor their condition and their therapy, and interact with individuals with similar conditions. Given our experience, these solutions aren’t so far fetched and could be real game changers for those that are able to successfully commercialize these drug delivery technologies.
About the Author
Ian Mawhinney leads the U.S. Medical Technology Practice at Cambridge Consultants. He holds a B.Sc in medical biochemistry and pharmacology & immunology from the University of London.
This article was published in Drug Discovery & Development magazine: Vol. 12, No. 10, November/December 2009, pp. 32-33.
Filed Under: Drug Discovery
