By Ed Miseta, Chief Editor, Clinical Leader
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Analysts forecast that by the end of 2016, 50 percent of the top 100 drugs on the market will be biologics. Currently more than 900 biologic drugs are in development to treat a broad range of conditions, including cancers, immunologic disorders, and rare and chronic diseases. That the majority of new injectable treatments are biologics will present a new challenge in delivery of the medicines. According to Michael Hooven, CEO of Enable Injections, these high-volume and often highly viscous drugs cannot be delivered with today’s legacy injection systems. He believes they must either be delivered intravenously or by novel drug delivery technologies that are safe, patient-friendly, and cost-effective. I spoke with Hooven about this trend and the impact it will have on both patients and sponsors.
Ed Miseta: Why are new drug delivery technologies important to clinical trials and healthcare?
Michael Hooven: The full benefit of biologic therapies, whether in the clinical space or the commercial space, can only be realized if patients are accepting of their treatment and adhere to their medication regimen. We now have a new generation of injectors that are wearable and offer patients the ability to receive their important and life-saving treatments with ease and comfort. By enabling convenient, safe and easy at-home self-administration of large molecule or viscous drugs, wearable injectors may revolutionize treatment of chronic conditions. As commercial launches begin, providing patients the option of at-home, at work, or on the go treatment administration is expected to become an important driver of uptake of biological treatments developed by pharmaceutical and biotechnology companies.
Miseta: What are some of the therapeutic areas suited to the use of wearable injectors?
Hooven: The market is expected to grow rapidly to over $8 billion in the next 10 years. According to a Roots Analysis Report 2014-2024, cancer and related conditions are expected to be the most researched area for wearable injectors. Other prominent target diseases are likely to be autoimmune diseases, blood disorders, and genetic disorders. One of the greatest promises of these systems and the reason they will likely be rapidly adopted relates to their ability to increase patient compliance and generate cost savings while increasing patient satisfaction.
Miseta: Why would wearable injectors increase patient compliance and adherence to treatments?
Hooven: The medical literature clearly demonstrates that taking medication as prescribed and for the recommended duration is problematic for many patients, and can significantly impact healthcare outcomes and cost of care. Nonadherence is a leading cause of preventable morbidity, mortality and cost. Yet, compliance among chronic disease patients averages just 50 percent. Difficulty of administration is among the major causes of failure to comply with prescribed medication. Injectable drug administration is particularly problematic for patients. Not surprisingly, most patients dislike injections, especially those that are self-administered. Wearable injectors are designed to address the challenges of complexity, patient compliance and cost by making self-injection safe, easy, comfortable and convenient for users – and cost-effective for the pharmaceutical industry and payers. Today’s most advanced wearable injector systems reduce or eliminate injection pain, remove needles from sight and require only a few simple steps for patients, which will likely result in increased compliance and overall satisfaction.
Miseta: What effect could the introduction of wearable injectors have on the healthcare system and costs?
Hooven: Safety, ease of use, and injection comfort are vital attributes if uncomplicated self-injection of biologics is to ever become a reality. Such a solution has the ability to move drug delivery from healthcare facilities into the home or workplace and from healthcare provider-mediated injection to self-administration. This could significantly reduce overall health system costs. For patients or caregivers, the benefit of no longer needing to travel for treatment is enormous. Not only would travel be eliminated, as has proven popular with now dominant online shopping, but treatment time would be reduced as well. For example, intravenous administration of the drug Herceptin for the treatment of breast cancer takes 30-90 minutes in a healthcare facility. In contrast, subcutaneous administration of the same dose with a wearable injector could take just 2-5 minutes in the home. Then there are the costs of treatment at a healthcare facility to consider, which can be astronomical. A New York Times article cited a $133,000 charge for a single infusion for psoriatic arthritis at a hospital outpatient clinic – of which the insurer paid $99,593.
Miseta: What are the potential benefits to biopharmaceutical companies?
Hooven: Reducing complexity of development and delivery of biologics and its associated cost is one of the biggest obstacles facing companies developing medicines to revolutionize the treatment of serious and chronic diseases. Injectable drug administration is particularly problematic. Significant drug development time and cost can be reduced with use of injectors that utilize standard vials, syringes or cartridges so no change to the primary container is required. This eliminates drug stability issues with non-standard containers and can reduce overall manufacturing cost by eliminating the need for additional equipment such as filling lines. The ability to deliver higher volumes of product in a patient-accepted manner can also reduce product development costs through reduced formulation times. It may not be necessary to spend additional time formulating highly viscous products to volumes typically associated with current injection devices such as auto-injectors.
Miseta: Is there an increased element of safety here as well, for both patients and health care workers?
Hooven: Absolutely. Another reason why adoption of wearable injectors is expected to be fast-paced is that safety aspect they provide by eliminating some of the risks associated with conventional infusion and injection technologies. These include drug preparation, needle insertion, and covering and disposing of needles. With modern wearable systems, the needle is never seen or exposed to the patient. Instead, the needle is inserted after the injector is affixed and the button pushed to begin treatment. At the end of the injection, the needle automatically retracts and is locked out, allowing for safe and convenient disposal of the system. The patient is discreetly alerted with tactile, audible or visual cues to the end of treatment. Removing healthcare providers from the drug administration process could result in far fewer needle stick injuries that every day endanger those who provide treatment with intravenous injectable treatments or syringes.
Miseta: Please tell us a little about your background and current involvement with wearable injection devices.
Hooven: I have a BS in Physics and an MSME in Fluid Mechanics from the University of Michigan. My first job was at Cordis Corporation where I managed neurosurgical device engineering for five years. I moved to Siemens-Pacesetter where I managed Pacemaker development for two years, and came to Cincinnati in 1988 to head-up all internal device development for Ethicon Endosurgery. After six years I started my first company, Enable Medical Corporation, which developed, manufactured and sold bipolar RF surgical instruments. In 2000 I founded AtriCure (NASDAQ:ATRC), a company involved in the surgical treatment of Atrial Fibrillation. Enable Medical was acquired in 2005, and I left AtriCure in 2008, but remain today as a Director. I founded Enable Injections in 2010 and am the President and CEO.