The untold story of Nemera’s inhalation franchise

Introduction and disease overview:

Imagine the sheer joy and excitement of a child running towards an ice cream truck on a hot sunny day or an athlete as he crosses the finish line to win a sprint! Sounds terrific, right? But did you know that around 800 million people[1] around the world might not feel this joy because they suffer from respiratory disorders, notably, asthma and chronic obstructive pulmonary disease (COPD).

In simple terms, asthma is a medical condition that makes breathing difficult by causing the air passages to become narrow or blocked especially during an asthma exacerbation. This in turn leads to wheezing, coughing, shortness of breath and chest tightness. Asthma is thought to be caused by a combination of genetic and environmental factors. For example, based on what we know about the recent COVID-19 virus, people suffering from asthma might be more exposed to severe illnesses. Under such circumstances, care and treatment options for these patient populations become all the more urgent. Contrary to other medical conditions, there is no cure for asthma. On the brighter side, medications help prevent exacerbation and attenuate the symptoms.

Chronic obstructive pulmonary disease (COPD) is another debilitating disease characterized by long-term breathing problems and poor airflow. The most common cause of COPD is tobacco smoking. Diagnosing COPD is a challenge as most people do not realize they have it and do not reveal their symptoms to their doctors. The breathing problems tend to worsen over time and can limit an individual’s day-to-day activities.

Unmet medical needs:

Although asthma and COPD are long-term conditions with no permanent cure, the symptoms can be controlled with the right treatment. The oldest and the simplest way to treat lung diseases is with inhalation therapy. This is proven by the fact that over 1 billion inhalers[2] are sold globally every year. Moreover, these pulmonary conditions are expected to rise with increasing elderly population, air pollution, climate change and evolving lifestyles. There are still several unmet medical needs in this space and poor adherence of patients to treatments remains a big challenge. Adherence in real-life studies varies from 8% to 73%[3].  This challenge stems majorly from improper utilization of inhalation devices as well as lack of learning and training to those who handle these devices. A potential way forward could be the involvement of digital in the treatment journey of these patients. A connected device that reminds them to take their medication or warns them of changing climate to ensure they’re well-equipped with their treatment if there’s a peak in pollution, and so on!

The journey from contract manufacturing to an end-to-end partner:

As a world leader in drug delivery devices, Nemera has been instrumental in the inhalation space for over 20 years. Historically, popularly known for contract manufacturing which essentially means industrialization of an already developed device, Nemera is now recognized as a holistic partner for inhalers. Nemera’s journey from a contract manufacturer to an end-to-end partner in inhalation is worth exploring.

Nemera set foot in the inhalation space with Diskus® for the leading pharmaceutical company Glaxo SmithKline popularly known as GSK in 1998. Today, the form and purple colour of Diskus, among others of the range, are a reference and a mark of trust across the world. This first success then snowballed into other solid collaborations with blockbusters in the pharma industry and generic players specialized in inhalation fields.

Over 1500 people are dedicated to industrialization and manufacturing at Nemera to make sure we respond to small and large scale manufacturing needs of our customers with precision. Thanks to our robust manufacturing capabilities coupled with outstanding quality we have manufactured over a billion inhalers to date. Approximately 20 million patients rely on inhalers manufactured by Nemera everyday.[4] Numbers say a lot but they don’t tell the whole story!

At Nemera, our people are driven by our purpose of putting patients first. The end-user of our product is a person who has trouble breathing or undertaking simple daily chores. The fact that our devices help these people motivates our employees not only to wake up in the morning but to learn and improve constantly. We have significantly developed our injection, molding and assembly capabilities over the last few years to improve speed and on-line control. We have added electronic devices to our portfolio and share best practices within our different franchises. For instance, we are looking at exploring how human factor studies and user-design experiences in our parenteral franchise can be applied within our inhalation franchise.

Our early contract manufacturing included primarily dry powder inhalers (DPIs). DPIs can be preloaded with the medication(s) or a patient can load it with capsules as the dose-holding system, prior to use. A single dose of the medication is loaded and ready to be inhaled, for example, by sliding a lever, twisting a part of the device or, in the case of capsule devices, pressing buttons to pierce the capsule. Patients simply take a deep breath while their lips are sealed around the mouthpiece of the inhaler, and the dose is delivered.

Then came actuator and dose counters for pressurized metered-dose inhalers (pMDIs). These devices consist of an aluminum canister of medication covered by a valve fitted into a plastic body with a mouthpiece (the actuator). Each dose is delivered by pressing the canister into the actuator while inhaling through the mouthpiece. Sometimes, a dose counter can be added or integrated to the system.

Inhalation devices are often complex because the inspiratory flow is linked to device resistance. In DPIs for instance, a patient’s breathing capacity is critical in generating the desired therapeutic outcome as the dispersed powder needs to be broken into particles of the right size and be deposited appropriately into the lungs.

The best way of addressing these complexities is through early-stage research. Our innovation team works extensively on understanding the needs of patients, medical doctors and fulfilling pharmaceutical requirements so that the design we develop aims at resolving their issues. This also includes anticipating the needs of the future.

Thus, from early-stage concept development to manufacturing we are truly a holistic partner in inhalation.

Inhalers of tomorrow:

Nemera’s inhalation franchise stands on a solid foundation. We learn from the past, act in the present and build for the future. Our ambition moving forward is to participate more and more in discussions around inhalers of tomorrow: strive to ensure that our research takes into account sustainability and environment related factors, evolving patient needs, increasing preference to digital and more. At Nemera, we embed digital organically. We have developed electronic devices that are tailored to enhance patient experience to facilitate treatment adherence. These smart devices are capable of monitoring drug dosages for complete patient safety. In addition, we propose cloud solutions to illustrate how the data generated can be analyzed for best outcomes. This would help us reflect around extending our digital offering in inhalation.

We are part of the Cupido (Cardio Ultraefficient nanoParticles for Inhalation of Drug product) project. Cupido aims to hit the core of the cardiovascular disease, developing inhalable nanoparticles that can deliver a therapy directly to the diseased heart. The EU-based consortium, composed of 6 academic research groups, 5 SMEs, 2 industries, and 1 pharmaceutical company, gathers a vast array of expertise and joins cutting-edge research with pre-clinical experience and industrial manufacturing. Our role in this promising consortium is to develop the inhaler that administers the nanoparticles to the diseased heart.

What we do today has a long-lasting impact on our future. And the future is full of unexplored opportunities and hope!

[1] Source : Nemera compilation of Global data value, National Center for Biotechnology Information (NCBI), Global Asthma Report 2018

[2] Source : IQVIA – MIDAS & Analytics link + internal Nemera

[3] Source: Real-life Inhaler Adherence and Technique: Time to get smarter! – Henry Chrystyn, Raphaele Audibert, Manfred Keller, Benjamin Quaglia, Laurent Vecellio, Nicolas Roche.

[4] Source : Internal Nemera