Wearable Large Volume Drug Delivery Devices

Hold key to pharmaceutical lifecycle management, patient preference

Michael D Hooven,  President and CEO, Enable Injections Inc., USA

Pharmaceutical companies racing to develop promising new biologic treatments are embracing disruptive drug delivery technology. Patient-friendly wearable large volume injectors from Enable Injections make at home delivery of large volume (5-50ml), viscous drugs easy, comfortable and convenient, promoting compliance. They can differentiate products, extend product life cycles and impact treatment outcomes positively.

It costs approximately US$2.6 billion (17,904,380,000 yuan) to bring a single new drug to market-and the cost, as well as the hurdles to innovation, are getting higher. Yet innovation is crucial to the pharmaceutical industry, and the need for a strong product pipeline is sending companies racing to develop some of the most promising new treatments—biologics-in the hope of developing another blockbuster drug like- Humira, AbbVie’s biologic treatment for rheumatoid arthritis and related diseases. Humira sales topped US$14 billion in 2015, and AbbVie raised its earnings forecast for 2016. Another 39 biologics also reached blockbuster status last year, exceeding US$1  billion in sales. Nine of these biologics brought in US$5 billion in global sales. Biologics continue to be the main drivers of industry growth and are predicted to reach US 445 billion in sales by 2019, up from US$289 billion from 2014.

However, a Deloitte 2016 pharmaceutical industry report1 states that while drugs will remain important, they will represent a diminishing share of what comes together to deliver an overall outcome. For pharmaceutical companies this emerging trend means growth will depend on innovation beyond just finding new drug candidates.

Luckily, disruptive innovation that can positively impact outcomes, create patient preference and lower drug development costs has arrived in the form of wearable large volume subcutaneous injection technology that makes it easy for patients to self-administer doses as large as 5mL to 50 mL at home with minimal if any discomfort.

A second trend, patient centricity, has long been embraced by pharmaceutical companies. Industry leaders Roche/ Genentech and Novartis, for example, have produced some of the most successful products of the last decade—Avastin, Rituxan, Herceptin, and Gleevec. To what do these drugs owe much of their product leadership? To the companies’ focus on the continual drive to improve the patient experience.

Nowhere is disruptive drug delivery innovation to enhance the patient experience more critical than with the large volume, viscous biologics that now comprise more than 50 per cent of products in pharmaceutical development. For these drugs, subcutaneous delivery has been a major goal and chronic challenge until now.

Now pharmaceutical companies can seize the opportunity to be in the forefront of both trends by marrying their large molecule drug products to revolutionary patient-centric drug delivery and reap the benefits, just as Alibaba and Amazon have done by revolutionising shopping.

Amazon, Alibaba and many others offer home delivery. It’s popular. It’s convenient. With use of the new wearable drug delivery technology, pharmaceutical companies can also offer patients home delivery, although of a slightly different nature but equally desirable – the ability to skip the trip to the hospital for an infusion and instead easily self-inject biologics, with minimal or no pain, in the comfort of their own homes using the newly available more advanced high volume injectors like those from Enable Injections. For example, a patient requiring an infusion for treatment of an autoimmune disorder must travel to a health facility for a 30 to 90 minute IV infusion. Using a wearable large volume injector instead, the same dose can easily and comfortably be self-administered by the patient at home, at work or in transit in just a few minutes. There is no needle in sight and the patient, no longer tethered to an IV line, is free to ambulate during treatment, making the experience far less stressful.

These innovative drug / drug delivery partnerships help assure that once the new drug/device combinations reach the market, their value proposition is realised as the result of improved compliance, a requisite for improved outcomes. In large markets like the US, reimbursement is soon to be determined by outcomes, making effective new technologies that boost compliance imperative.

Remove complexity to boost compliance

The medical literature leaves little doubt that taking medication as prescribed and for the recommended time period is problematic for many patients and can significantly impact healthcare outcomes and cost of care. A World Health Organization (WHO) report cites non-adherence as a leading cause of preventable morbidity, mortality and cost. Yet compliance among chronic disease patients averages just 50 per cent.

The WHO report cites complexity among the major causes of failure to comply with prescribed medication.

Reducing this complexity and its associated cost is another major challenge facing the pharmaceutical and biotech companies developing the biologics, monoclonal antibodies and immunoglobulins that are transforming treatment of cancers and chronic diseases.

The most advanced wearable large volume injectors, such as the Enable Injector, are designed to eliminate complexity, potentially helping create tomorrow’s blockbusters. Patient confusion and error are minimised by requiring only a few simple steps:

• INSERT a standard drug vial/syringe/cartridge into the transfer system, which automatically warms any refrigerated product in the 30-40 seconds it takes to fill the on-body delivery system
• PLACE the injector on skin
• PULL the safety tab
• PRESS one button.

New wearables extend product lifecycles

Biologics hold great promise for treating a multitude of illnesses. Cancers and related conditions are the most researched area for biologics, according to analysts. Other prominent target diseases are autoimmune diseases, blood disorders and genetic disorders. The list includes, but is not limited to:

• Numerous cancers
• Rheumatoid Arthritis
• Multiple Sclerosis
• Hemophilia
• Myasthenia gravis
• Lupus
• Vasculitis
• Sickle cell anemia
• Crohn’s Disease, ulcerative colitis and other digestive disorders
• Duchenne muscular dystrophy, Pompe disease and other genetic diseases
• Infectious diseases such as HIV, Ebola and CMV diseases
• Transplantation
• Inflammatory diseases
• Cardiovascular diseases
• Respiratory diseases
• Musculoskeletal disorders
• Eye diseases
• Skin diseases
• Neurologic disorders.

Improving the patient experience rewards pharmas

Already, 11 established biologic products representing 48per cent of total biologic sales are slated to lose patent protection by 2022. Companies with biologics on the market can take advantage of the new drug delivery technology to plan their patent extension strategies—and at the same time enter the next frontier in vastly improving the patient experience, creating preference. They can also use the technology to differentiate their emerging or young commercial products.

But biologics development creates challenges, and again the new wearable technology can be of assistance.

Wearables technology speeds development, formulation

Why change the way pharmas create and administer drugs? Because the need to reduce costs, increase efficiency and maintain margins is increasing pressure on pharmaceutical executives to be more creative. Ultimately, changes are likely to pay off. From the drug development point-of-view, the new delivery technology can cut costs and speed time to market.

Here’s why. Most biologics consist of mega-molecules that are hundreds of times the size of conventional small molecule drugs. Biologics are frequently composed of a heterogeneous mixture of more than 1,300 weighty amino acids. That creates three main challenges for pharmaceutical companies seeking to develop the next blockbuster biologic:

1.They are hard to make
2.They are hard to take
3.They can be expensive

Despite these difficulties, targeted as they are to particular genes or proteins, biologics are compelling for treating diseases due to their higher specificity and fewer side effects.

Scientists developing biotherapeutics spend enormous time and effort on formulation–sometimes years. This amount of time and effort can be significantly reduced by the newest biologics delivery technology.

The wearable large volume injectors bring to market a novel product development aid that reduces formulation time nd effort by enabling a simpler method of product preparation. Formulation teams can take advantage of the innovative delivery technology to speed development of stable, bioavailable, clinically relevant formulations.

Formulation teams can also facilitate patient self-injection of biologics by adopting drug delivery technology that aids in:

• Delivering more volume of product
• Delivering much higher viscosities caused by higher concentration of proteins
• Resolving biologics’ greater propensity

The time and effort savings are accomplished with automated processes performed by the Enable Injector that accelerate or eliminates tedious, time-consuming formulation functions for more rapid-and less costlyproduct development. In addition, the requirement for formulation teams to concentrate the product in the smallest possible dose for delivery by an autoinjector (typically <1ml) may no longer be relevant. The latest generation of injectors has the ability to provide a comfortable injection experience for higher volume product delivery. Patient acceptance of new higher volume on-body delivery systems should be high since the devices support mobility, are easy to use and minimise any injection discomfort. to precipitate out of solution.

For patients, biologics are now easy to take

Subcutaneous injection remains the preferred method of delivering injectable drugs, including biologics. Yet historically injectable drug administration has been particularly problematic, in large part because most patients dislike injections, especially those that are selfadministered. Injecting biologics would be even more painful and difficult for patients due to the large doses required and their viscosity. Syringes and earlier large volume injectors cannot handle anywhere near doses of up to 50 mL or their viscous formulations.

But now such large doses are possible for patients to self-inject easily and comfortably. Today’s wearable high volume injectors offer safety, ease of use, and injection comfort-vital attributes if uncomplicated self-injection of biologics is to gain traction. The new delivery technology is also connected and can monitor compliance, potentially a major step in improving data collection to assess and enable HCP intervention to help improve, treatment outcomes.

Fulfilling the vision of self-injection that is safe, easy, comfortable and convenient for patients, yet cost effectiveness for the pharmaceutical industry and payers, today’s most sophisticated drug delivery devices are distinguished by the following:

• Use standard vials, syringes or cartridges so no change to the primary container is required. This eliminates additional time-consuming and expensive stability studies

• Automatically warm the drug as the injector fills, reducing the typical 30-minute or longer wait time to use a refrigerated drug to seconds

• For lyophilized drugs, completely automate mixing and reconstitution, removing any patient variability from the mixing process

• Use only standard intravenous-set materials in the drug delivery path, minimising short-term material-drug compatibility issues

• Use a small needle size to optimise injection comfort

• Very small in size with a low profile that can discretely be worn on the body, eliminating the problems and inconvenience associated with carrying larger, heavier devices while ambulating

• Environmentally friendly – no electronics or batteries to remove or recycle

• Total volume of materials and packing less than that for a standard IV set

• Enable subcutaneous injection up to 50 mL

• Customisable drug delivery rate, duration, volume and needle size for creation of a much improved patient injection experience

• Apps-based connectivity.

Will these factors boost compliance?

Overall drug regimen compliance has historically been low, and any improvement would benefit both patients and drug makers. It remains to be seen to what extent the ease and convenience of using biologic/device combinations will impact compliance, improve outcomes and reduce drug wastage. Their connectivity will be helpful in that assessment.

It looks promising. Among the key attractions of the newest on-body delivery systems: with never a needle in sight, patients like using them, removing the many barriers to compliance that have vexed the industry for decades.

Summary: to profit, partner

The new, most advanced wearable large volume injectors available now for clinical trials and commercial application are designed to address the challenges of formulating biologics, delivery complexity, patient compliance and cost. Biologics/patient-centric delivery device partnerships are key to pharmaceutical product lifecycle management and brand preference.

References:

1. 2016 Global Life Sciences Outlook. Deloitte
2.Going Large. The Economist, January 3, 2015
3. Espiritu MJ, Collier AC and Bingham, JP. A 21st-century approach to age-old problems: the ascension of biologics in clinical therapeutics.  Drug Discovery Today 2014:19(8), 1109-1113.
4. Cai W, Wang Y, Xia R and Gao F. Closing the Gap between Preclinical Biologic Development and Clinical Application in Rheumatoid Arthritis. West Indian Med J. 2015:64(3), 312-313.
5. The World Health Report – Shaping the Future, 2003

-- Issue 26 --

Author Bio

Michael D Hooven

Michael D Hooven is President and CEO, Enable Injections, Inc. He has over 30 years of experience in the medical device industry in a broad variety of business, technical, and clinical areas. He is the Founder of five medical device companies and holds over 100 issued and pending US patents. He is the Founder and a Director of AtriCure, Inc. where he previously held positions as the Chairman and CEO. He is also Founder and Chairman of Enable Medical, a surgical device manufacturer that was acquired by AtriCure in August of 2005.

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