DevPro Biopharma and Bespak have introduced the completion of early feasibility research on DP007, a brand new formulation of albuterol in a pressurized metered dose inhaler (pMDI) which reveals comparable efficiency to Ventolin® HFA however with a major discount in greenhouse fuel emissions. This breakthrough pMDI is being developed by DevPro Biopharma, a respiratory-focused medical growth accelerator, and Bespak, a number one contract growth and manufacturing group (CDMO) targeted on orally inhaled and nasal drug-device mixture merchandise. Medical research are deliberate to be initiated by the top of the yr to fast-track its growth, because the pharmaceutical business begins to speed up its transition to climate-friendly respiratory care.
The preliminary outcomes might be offered on Might 18, 2024, on the 2024 Respiratory Innovation Summit, hosted by the American Thoracic Society (ATS) throughout their 2024 Worldwide Convention on the San Diego Conference Middle, San Diego, CA.
The brand new formulation has the potential to revolutionize the remedy of respiratory illness by lowering the worldwide warming potential (GWP) impression of albuterol inhalers equivalent to Ventolin, essentially the most generally prescribed inhaler sort globally. It’s anticipated to be commercialized by mid-2027 to satisfy the necessities of the US phasedown of fluorinated gases beneath the American Innovation and Manufacturing Act of 2020.
As many as 384 million individuals globally endure from persistent obstructive pulmonary illness (COPD), and about 262 million individuals endure from bronchial asthma. Most of those sufferers are handled utilizing pMDIs which have a excessive GWP attributable to the usage of greenhouse gases referred to as hydrofluoroalkanes (HFAs) as propellants. Greenhouse fuel emissions problem efforts to maintain the worldwide temperature rise at or beneath 2 °C this century, and regulation is being tightened internationally in consequence.
The progressive formulation is being developed by Bespak at its Analysis Triangle Park, NC analysis facility beneath the phrases of an unique settlement with DevPro Biopharma. The brand new formulation comprises Honeywell’s Solstice® Air (HFO-1234ze(E) cGMP), a hydrofluoroolefin (HFO) propellant that has 99.9% much less international warming potential than present HFAs and is in medical growth for pMDI merchandise. This announcement follows an earlier announcement of the industrial partnership between Bespak and Honeywell to hurry the event of near-zero GWP inhalers.
Colin Reisner, CEO of DevPro Biopharma, mentioned, “Albuterol pMDIs account for about 45% of all pMDIs used worldwide, contributing considerably to international warming. Within the US, about 60 million prescriptions are written yearly
for albuterol pMDIs producing emissions equal to greater than 200,000 passenger automobiles. There may be an pressing have to develop a low-GWP albuterol pMDI to cut back the environmental impression of the life-saving inhalers sufferers want, with out sacrificing efficiency or ease-of-use. Working with Bespak, we’re excited concerning the outcomes we now have seen with DP007 displaying comparable efficiency with Ventolin HFA. Primarily based on our personal market analysis, it has the potential to generate peak gross sales in extra of $500 million USD yearly.”
Chris Hirst, CEO of Bespak, commented, “We’re dedicated to main the transition to low-GWP propellants in pMDIs to assist halt the worldwide warming attributable to greenhouse gases. Bespak has an extended historical past within the growth, scale-up, and medical and industrial provide of inhalers and our objective now’s to transition as many pMDI merchandise as potential to satisfy the necessities of evolving international laws. We consider in not solely leveraging our personal abilities and capabilities, together with our experience in valves, actuators, and dose counters, but in addition working collectively throughout the business to attain this objective. Constructing on our partnership with Honeywell, we’re proud to companion with the skilled staff at DevPro Biopharma on this thrilling growth.”
This can be a low danger, excessive reward growth program with alternative for a significant discount in international warming. We now have assembled a world-class staff of consultants from Bespak and DevPro Biopharma who’ve developed the plan collectively for the following part of this system to rapidly de-risk the asset. We’re inspired by curiosity in this system and sit up for talking with potential buyers at ATS 2024 Respiratory Innovation Summit.”
Chris Hirst, CEO, Bespak
DevPro Biopharma is inviting expressions of curiosity from buyers and pharmaceutical organizations within the subsequent part of the event program.