May 11, 2022 St. Paul, MN — Kindeva Drug Delivery (Kindeva) and Breath of Life International (BOL Pharma or BOL) have agreed to the use of low GWP propellants in multiple inhaled cannabinoid products. Kindeva will develop novel formulations of BOL Pharma’s cannabinoid-based drug products delivered by Kindeva’s pressurized metered-dose inhaler (pMDI) technology using the next generation of low GWP propellants. Subject to all required regulatory approvals, the products under development are targeted to treat chronic neuropathic pain. If successful, this early-stage activity could lead to the long-term commercial supply of regulated inhaled cannabinoid products using low GWP propellants, leveraging Kindeva’s commercial manufacturing capabilities and BOL’s accumulated know-how and innovation in the field of medical cannabis.
Kindeva, a global contract development and manufacturing organization (CDMO), has a historical legacy of solving complex drug delivery challenges in the pharmaceutical, biotechnology, and life sciences sectors. The company has over 60 years of development-driven innovation across multiple drug delivery technologies, including inhalation, transdermal, and microneedles. In inhalation, Kindeva’s list of novel achievements includes the invention of the world’s first pMDI and the world’s first CFC-free pMDI. Leading the way in the use of a new generation of low GWP propellants offers yet another example of Kindeva’s leadership in sustainability in the inhalation market.
“We are excited to share our expertise in formulating pMDIs using low GWP propellants with BOL Pharma,” said Aaron Mann, CEO of Kindeva Drug Delivery. “This is a partnership between two highly innovative and growing companies. BOL Pharma is an acknowledged leader in medical cannabis, and I’m excited that Kindeva can support its progress in this space and help bring its products to market in a sustainable way. Kindeva’s recently announced low GWP pMDI manufacturing expansions enable us to be a strategic partner to BOL Pharma throughout the development lifecycle. Most importantly, the successful development of these products could ultimately offer patients a new, valuable, and sustainable tool for treating truly debilitating conditions.”
“We are excited to form a partnership with Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, a recognized global leader in the development of complex drugs, to develop a best-in-class low GWP inhaler,” said Kfir Avraham, CEO of BOL Pharma. “Entering into this sustainable inhaler space aligns perfectly with BOL Pharma. Cannabinoids are a naturally derived API so it makes sense for us to seek out a propellant that will have minimal impact on our planet whilst resulting in the effective delivery of API to the lung.”
This announcement highlights the growing opportunity for inhaled drug delivery to expand into adjacent therapy areas and indications in a sustainable way. In recent years, Kindeva has been actively identifying and progressing new development opportunities in inhalation that go beyond asthma and COPD. “The BOL partnership demonstrates how broad and effective inhaled drug delivery can be,” Mann said. “Applications for inhaled therapies go beyond respiratory diseases. In this case, we’re looking at the systemic delivery of drugs via the lungs to help patients with chronic neuropathic pain conditions.”
The products are being developed for multiple markets worldwide, including the United States, the United Kingdom, and the European Union. “With Kindeva as our partner, BOL Pharma is committed to testing this best-in-class inhaler utilizing a low GWP propellant in clinical trials, to establish the safety and efficacy in chronic neuropathic pain, in consultation with the FDA and EMA,” said Natalia Ashtamker, MD, Head of Global Clinical Development at BOL Pharma.
About Kindeva Drug Delivery
Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including autoinjectors, inhalers, transdermal patches, and microneedles. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base in the commercial and health security markets from its nine manufacturing and research and development facilities located in the U.S. and U.K. For more information, please visit www.kindevadd.com.
About BOL Pharma
BOL Pharma is a vertically integrated company in the medical cannabis and cannabinoid-based pharmaceutical industries with operations spanning the value chain from cultivation through production and extraction, formulation and product development, and product research and testing. BOL Pharma is one of the first licensed medical cannabis cultivators in Israel and has been at the forefront of the Israeli medical cannabis industry since 2008. BOL Pharma’s commitment to research and development and well-established partnerships with key universities, medical centers, and corporations is rooted in its culture of innovation. BOL Pharma is currently the only company in Israel accredited by the Ministry of Health of Israel (“Ministry of Health”) with both Israeli Medical Cannabis Good Agricultural Practices (“IMC-GAP”) certification for propagation and cultivation, Good Manufacturing Practices (“IMC-GMP”) certification for manufacturing of cannabis finished products, and EU-GMP for API manufacturing. These certifications authorize us to have our medical cannabis and cannabinoid-based APIs sold in pharmacies in Israel and the global markets. For more information, visit www.Bolpharma.com.