DevPro Biopharma and Bespak Announce Completion of Early Feasibility Studies for DP007, a Novel Pressurized Metered Dose Inhaler (pMDI) Albuterol Formulation Showing Comparable Performance to Ventolin® HFA but with a significant reduction in greenhouse gas emissions. This breakthrough pMDI is being developed by DevPro Biopharma, a respiratory-focused clinical development accelerator, and Bespak, a leading contract development and manufacturing organization (CDMO) focused on oral and nasal drug-device combination products. Clinical studies are planned to begin by the end of the year to accelerate its development as the pharmaceutical industry begins to accelerate its transition to climate-friendly respiratory care.
Preliminary results will be presented on May 18, 2024, at the 2024 Respiratory Innovation Summit, hosted by the American Thoracic Society (ATS) during the 2024 International Congress at the San Diego Convention Center, San Diego, CA.
The new formulation has the potential to revolutionize the treatment of respiratory disease by reducing the global warming potential (GWP) impact of albuterol inhalers such as Ventolin, the most commonly prescribed type of inhaler worldwide. It is expected to be commercially available by mid-2027 to meet the requirements of the phasing out of fluorinated gases in the US under the American Innovation and Manufacturing Act of 2020.
About 384 million people worldwide suffer from chronic obstructive pulmonary disease (COPD) and about 262 million people suffer from asthma. Most of these patients are treated using pMDIs that have a high GWP due to the use of greenhouse gases known as hydrofluoroalkanes (HFAs) as propellants. Greenhouse gas emissions are challenging efforts to keep global warming to 2 °C or below this century, and as a result regulations are tightening around the world.
The innovative formulation is being developed by Bespak at its research facility in Research Triangle Park, NC under the terms of an exclusive agreement with DevPro Biopharma. The new formulation contains Honeywell’s Solstice® Air (HFO-1234ze(E) cGMP), a hydrofluoroolefin (HFO) propellant that has 99.9% less global warming potential than current HFAs and is in clinical development for pMDI products. This announcement follows an earlier announcement of a commercial partnership between Bespak and Honeywell to accelerate the development of near-zero GWP inhalers.
Colin Reisner, CEO of DevPro Biopharma, said: “Albuterol pMDIs account for approximately 45% of all pMDIs used worldwide, contributing substantially to global warming. In the US, approximately 60 million prescriptions are written annually
for albuterol pMDIs that produce emissions equivalent to more than 200,000 passenger vehicles. There is an urgent need to develop a low-GWP albuterol pMDI to reduce the environmental impact of patient-required life-saving inhalers without sacrificing performance or ease of use. Working with Bespak, we are thrilled with the results we have seen with DP007 showing comparable performance to Ventolin HFA. Based on our own market research, it has the potential to generate top-line sales in excess of $500 million annually.”
Chris Hirst, CEO of Bespak, commented: “We are committed to driving the transition to low GWP propellants in pMDI to help stop global warming caused by greenhouse gases. Bespak has a long history of developing, scaling and clinical and commercial supply of inhalation devices and our aim now is to bring as many pMDI products as possible to meet the requirements of evolving global legislation. We believe in not only leveraging our skills and capabilities, including our expertise in valves, actuators and dose meters, but also in working together across the industry to achieve this. Building on our partnership with Honeywell, we are proud to work with DevPro Biopharma’s experienced team on this exciting development.”
This is a low-risk, high-reward development program with an opportunity to significantly reduce global warming. We assembled a team of world-class experts from Bespak and DevPro Biopharma, who together developed the plan for the next phase of the program to quickly eliminate the asset. We are encouraged by the interest in the program and look forward to speaking with potential investors at the ATS 2024 Respiratory Innovation Summit.”
Chris Hirst, CEO, Bespak
DevPro Biopharma invites expression of interest from investors and pharmaceutical organizations in the next phase of the development program.
