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In this opinion article, the authors pose the question, “Can we improve accessibility and affordability of orally inhaled therapies while protecting incentives for the development of innovative products?” and invite readers to join a discussion. Point of view: Overcoming barriers to affordability of orally inhaled products while protecting innovation Aligning incentives for innovators and generic developers of orally inhaled products Igor Gonda, PhD a ; Philippe Rogueda, PhD b and David Cipolla, PhD c Respidex, LLC Merxin, Limited Insmed, Incorporated timelines and the associated cost and risk of drug devel- opment are significant components. This applies to innovative products as well as generic medications. Development of new drugs in general and pulmo- nary drugs in particular, is a very risky endeavor. As an illustration, from 2006-2015 in the United States, the failure rate for all respiratory products (including biologics) from Phase I to approval was almost 90%. 2 Even the failure rate of products in late stage develop- ment (Phase III to approval) was significant, at 33.7%. Failure rates for inhaled products are likely to be even greater, as biologics are included in these statistics and, typically, these have markedly higher success rates. 3 It is therefore natural that the innovator companies and their investors look for long periods of protection to be rewarded for the risk, length and cost of respiratory product development. The patent laws no longer provide adequately long periods of exclusivity to reflect the increasing length of innovative pharmaceutical product development; i.e., the twenty-year patent life begins at the time of patent filing, which is typically very early in product develop- ment and can be ten to fifteen years prior to product approval. Some estimates suggest that the remaining patent life after product approval is, in many cases, as low as seven to ten years. 4 Additional exclusivity, in the variety of regulatory rules introduced initially in the Hatch-Waxman Act, and more recently in the form of other initiatives (e.g., the Generating Antibiotic Incen- tives Now (GAIN) Act and the 21st Century Cures Act), is also possible. 5 Respiratory diseases are a major worldwide healthcare problem 1 and their prevalence is likely to increase due to a multitude of factors, including air pollution, the incidence of smoking and vaping, and aging of the population. e rapid global spread of the COVID-19 infection has been a stark reminder of our vulnerability to life-threatening respiratory diseases and the need for an industry that can quickly and effectively respond to such crises. Chronic obstructive pulmonary diseases (COPDs) are one of the leading causes of morbidity and mortality in many countries. 1 Influenza and asthma also affect large populations and contribute to enormous and rising healthcare costs. Tuberculosis remains a pain- ful reminder, especially in developing countries, that respiratory infections of the past could come back with a vengeance in the form of multi-drug resistant strains and become endemic in parts of the world. 1 Furthermore, there are many less-common respiratory diseases, including cystic fibrosis, bronchiectasis, pul- monary arterial hypertension and pulmonary fibrosis, as well as numerous severe chronic lung infections that contribute to the global burden of respiratory diseases. Many patients around the world already benefit from inhaled treatments for these diseases, but for many more, they are unavailable or unaffordable. Accessibility and affordability of inhaled medications (orally inhaled products or OIPs) should be an import- ant focus for improving health care outcomes globally. While there are many factors that impact the availabil- ity and pricing of inhaled drugs, long development Inhalation June 2020 21

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